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    Effectiveness ofcommunication strategiesembedded in socialmarketing programmes onhealth behaviours andrelated health and welfare

    outcomes in Low and MiddleIncome Countries (LMICs)

    Eva Riboli-Sasco, Jacqueline Leslie, Lambert Felix, RoyHead, Josip Car, Laura H. Gunn

    PROTOCOL

    Publication date: 02 March, 2015

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    Table of contents

    TABLE OF CONTENTS 3 

    1  BACKGROUND 3 

    1.1  Description of the problem 3 

    1.2  Description of the intervention 5 

    1.3 

    How the intervention might work 6 

    1.4   Why it is important to do this review 11 

    2  OBJECTIVE OF THE REVIEW 14 

    3  METHODS 16 

    3.1  Criteria for including studies in the review [PICOS] 16 

    3.2  Search methods for identification of studies 21 

    3.3  Data collection and analysis 26 

    3.4  Data synthesis 31 

    4  TIMELINE 35 

    5   ACKNOWLEDGEMENTS 36  

    6  REFERENCES 37

    7   APPENDIX 46  

    8  CONTRIBUTION OF AUTHORS 52 

    9  DECLARATIONS OF INTEREST 53 

    10   SOURCES OF SUPPORT 54 

    10.1  Internal sources 54 

    10.2  External sources 54 

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    Background

    1.1   DESCRIPTION OF THE PROBLEM

    Human behaviour plays a significant role in the leading causes of disease, disability,

    and death (Marteau, Hollands, & Fletcher, 2012). In developed countries, health

    programmes use behaviour change communication to provide tailored messages and

    a supportive environment that persuades individuals and encourages communities to

    make better health changes (Glanz & Bishop, 2010; Gordon et al. 2006). For example,

    many studies have examined behaviours like smoking cessation, dieting and exercise,

    since these are important contributors to urgent health issues in developed countries

    (Glanz & Bishop, 2010; Gordon et al., 2006; Hastings et al. 2006). However, in the

    developing world it is becoming increasingly critical to address health issues and to

    find new methods of promoting behaviours that might prevent illness. Based on this

    reality, health communication campaigns have been developed to inform and

    promote the adoption of preventive practices, health products and services and to

    fight harmful cultural beliefs and behaviours, among groups and individuals (Snyder,

    Linkov, & Laporte, 2007).

    Health related communication strategies have changed significantly in the last 15

     years from top down public service announcements to a wider approach which draws

    on behaviour models and methods used in marketing and adapted for the purposes of

    "social marketing" (Figueroa et al., 2008; Lefebvre & Flora, 1988).

    Social marketing uses a consumer-focused approach based on behaviour, not

    awareness or attitude, change and/or maintenance to maximise sale and use of the

    product (for example, insecticide treated nets) or service (for example, peercounsellors) by segmented target groups, and uses a marketing mix or ‘‘4 Ps’’

    (product, price, place, promotion) (Perez-Escamilla, 2012) to provide products

    differentiated by brand, relevance, and positioning. The 4 ‘Ps’ are mostly used with

    tangible products, however for non-tangible products or services (for example, hand

     washing, exclusive breast feeding, regular exercise), a more appropriate marketing

    mix to use would include the “4 Cs” (consumer need/want/desire, cost, convenience,

    and communication) of Integrated Marketing Communication for Behavioural

    Impact (IMC/COMBI) (Hosein, Parks, & Schiavo, 2009). The UK National Social

    Marketing Centre (NSMC) has identified eight benchmark criteria defining key

    characteristics of social marketing programmes (see Section 3.1.3 for these criteria)

    (National Social Marketing Centre, 2010).

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    However the evidence on the effectiveness of social marketing and/or behaviour

    change communication strategies in the health and public health context is not always

     well synthesised, and often scattered across a number of subsectors in water and

    sanitation, family planning, mother and child health, malaria, and epidemic diseases

    such as HIV, polio, and avian influenza (Hornik, 2002; Bertrand et al., 2006). The

    effectiveness of the communication strategies reported can also be confounded by

    issues related to health product or service characteristics such as price, access, and

    ease of use.

    Early use of health communication relied on top-down one-way messages (Thackeray

    & Neiger, 2009). They did not take account of motivational factors and constraints,

    and as a result, these campaigns had limited impact (Pfeiffer, 2004). However,

    communication approaches continuously evolve. Behaviour change communication

    (BCC) is a more recent approach, which makes strategic use of communication to

    promote positive health outcomes. It is based on proven theories and models of

     behaviour change (and maintenance) and market segmentation. Segmentation is a

    group-level, or community/population, marketing approach, whereas behaviour

    change focuses primarily on individual actions. Both models of behaviour change and

    market segmentation are often used for community mobilisation, health and

    environmental education, and various public outreach programmes (Maibach et al.,

    2007; Grier and Bryant, 2005). However in some cases, the effectiveness of BCC can

     be constrained by other factors relating to product or service characteristics,

    availability, and cost (Price, 2001). In India, the National Family Planning

    programme uses BCC, however in selected areas, social marketing approaches were

    added in order to improve access to products and services (Gurgaon, 2012).

    Strategic communication is an important component of social marketing programmes

    (UNICEF, 2005). The purpose of any social marketing campaign is to change people’s

     behaviour (Andreasen, 1995), or maintain positive behaviour adoption (Hosein, et al.,

    2009). Social marketing is distinguished from other health and education campaigns

     by its adoption of commercial marketing principles, consumer orientated focus, and

    its use of integrated market analysis, segmentation, and marketing strategies (Noble

    & Camit, 2005). These are endorsed by the UK National Social Marketing Centre

    (NSMC) who recognises these as benchmarks of what is needed for a successful socialmarketing programme (NSMC, 2010).

    This review will assess the evidence on “what works” and the impact of BCC strategies

    in a social marketing environment on health behaviour and other health and welfare

    outcomes among individuals and their carers and communities. The review will draw

    on a wide range of public health programmes implemented in low- and middle-

    income countries (LMICs).

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    1.2   DESCRIPTION OF THE INTERVENTION

    Health communication is concerned with “informing, influencing and motivating

    individual, institutional [including community] and public audiences about

    important health issues”  (needs citation with page number) and engaging people

    through three principal approaches: individual messaging, social networks, and thepopulation or a community (Maibach, Abroms, & Marosits, 2007).

     A communication strategy has been defined by the Food and Agriculture Organization

    of the United Nations as “a systematic, well-planned series of actions, combining

    different methods, techniques and tools, to achieve an intended change or objective

    utilising the available resources within a specific time frame”  (Mefalopulos &

    Kamlongera, 2004, p. xx).

     Various communication strategies may be used within a campaign to change the

     behaviour of the target population (Snyder, 2007). Whether acting as an individual

    component or multi-component programme(s), single- or multi- media can be used

    at various levels, including locally, regionally, and nationally (Noar et al., 2009).

    Communication strategies can involve a range of complimentary components

    delivered by various channels and in different interventional forms, including public

    advocacy and public relations; awareness; mobilisation; education; and advertising,

    promotion, and incentivisation.

    Interventions can use a range of delivery channels including: mass media (for

    example, television, radio, newspapers, leaflets, and posters); educationalentertainment (that is “edutainment”; for example, songs and dances, road shows,

    dramas); interpersonal communication/counselling (for example, home visits,

    discussion groups and point-of-service); and digital or electronic communications

    (including individual mobile phone messaging and electronic social networks).

     Although “traditional” mass media such as television and radio remain common, so-

    called “new media” are increasingly being used in public communication campaigns

    (Parker and Thorson, 2009), including health behaviour change interventions (Edgar,

    Noar and Freimuth, 2008). This new field is referred to as eHealth. New media

    includes emerging digital technologies and platforms (for example, video games,

     virtual worlds, software, mobile devices), online communication (for example,

    Internet, blogs, chat rooms, wikis, e-mail, online newsletters) and electronic and

    multimedia publishing—multimedia CD-ROMs and hypertext (Shapiro et al., 2007) . 

    Their increasing success in health communication can be explained by the several

    additional features brought by such technologies, including:

    -  the use of multimedia applications, combining text, audio, video, graphics,

    and animation;

    the possibility of an interactive process, as opposed to the passivity of watching

    TV or listening to the radio;

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    -  the tailoring of information which pushes further the broader targeting of

    traditional campaigns by individualizing the message conveyed; and

    -  the use of hypertext which allows linkage of information with other related

    content (Pavlik, 2001).

     An important factor in this development has been the widespread usage of the

    Internet, on which health promoters are increasingly capitalizing (Webb et al., 2010).

    Examples of interventions include the setting up of an Internet-Based Peer

    Community dedicated to health information in Dakar, Senegal (Massey et al., 2009),

    Despite several successful experiences, in the general context of LMICs, the individual

    access to most new media, and particularly the Internet, often remains limited by

    several socioeconomic, political and geographical barriers (Edejer, 2000). While the

     World Bank estimated that 75.3% of the population in high-income countries had

    access to the Internet in 2012, the figures dropped to 29.8% in middle-income

    countries and 6.9% in low-income countries (World Bank, 2013a). As a result, thisusage limitation highly restricts the potential reach and impact of digital health

    communication campaigns utilising the Internet in LMICs.

     Whereas television, computers and landline phones tend to remain scarce in LMICs,

    mobile phones constitute a noticeable exception. With 41.5 mobile subscriptions for

    100 habitants in low-income countries and more than 80% in middle-income

    countries (World Bank, 2013a), this technology is becoming ubiquitous, including in

    the most deprived settings. Mobile phones, therefore, hold promising opportunities

    for delivering health related messages to a wide audience, in the form of text messages

    (Cole-Lewis and Kershaw, 2010) or apps (Cohn et al., 2011; Cowan et al., 2013).

    However, the effectiveness of such interventions is still debated, dependent on a

    multitude of internal and external factors, thus calling for high quality evidence-based

    evaluations (Noar and Harrington, 2012; Sood et al., 2014). This is even more true for

    LMICs where specific and often stronger social, economic and cultural constraints

    might arise, compromising the success of these eHealth interventions (Kaplan, 2006).

    Sood et al. (2014) conducted a review of health communication campaigns in

    developing countries; however a major difference between their review and ours is

    that our review will specifically address communication strategies embedded in social

    marketing programmes.

    1.3   HOW THE INTERVENTION MIGHT WORK

    Figure 1 (below) presents an example of a logic model we created which shows the

    connections between the possible variables identified in various theoretical models as

    determinants of behaviour change and/or maintenance and potential health and

     welfare outcomes, whether short term or intermediate-to-long term (Knowlton and

    Phillips, 2009; Patton, 2008).

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    Figure 1. Example of a logic model of possible variables considered in communication interventions and the inputs and

    channels used to affect short and intermediate-to-long term outcomes within a framework of social marketing health

    programmes 

    Model

    Socialmarketingframework

    Behaviourmodels

    McGuire'scommunication

    stages

    Audience

    Individuals

    Social & othernetworks

    Communities

    or

    populations

    Input

    Public advocacy& publicrelations

    Awareness

    Mobilisation

    Information &education

    Promotion,advertising, &incentivisation

    Channel

    Mass media

    Educationalentertainment

    Digital orelectronic

    communications

    Interpersonal

    Short Term

    Outcomes

    Communication& channel

    contact rates

    Cognitiveoutcomes

    Behaviourchange

    Changes indemand forservice orproduct

    Intermediate-to-Long

    TermOutcomes

    Health outcomes

    Welfareoutcomes

    Social outcomes

    Behaviour changeand/or

    maintenance

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     8 The Campbell Collaboration | www.campbellcollaboration.org

    Figure 1 portrays the theoretical models from a number of areas including behaviour

    change and/or maintenance, communication theory, and social marketing.

    Commonly used behaviour change (including maintenance) models include (though

    are not limited to): Health Belief Model (Janz & Becker, 1984), Theory of Planned

    Behaviour (Ajzen, 1991), and the Transtheoretical Model-Stages of Change

    (Prochaska & Velicer, 1997). These three models are associated with behaviour change

    at the individual level, whereas theories of mobilization and diffusion (for example,

    Community Mobilisation Theory (Rothman & Tropman, 1987) and Diffusions of

    Innovation Theory (Rogers, 2010)) are associated with the community level. The

    social marketing framework considers both individual and community levels.

    These models assume that any health or illness outcome is the consequence of the

    complex interaction between social, economic, psychological and biomedical factors

    (Edelman, 2000; Kelly et al., 2009). Essential components of these models and

    theories are the set of mediators and other variables on which they rely. A mediator

    is an intervening variable necessary to complete a cause-effect link between an

    intervention programme and the targeted health behaviour. Common mediators

    include, but are not restricted to: self-efficacy; attitudes towards the behaviour; fear;

    perceived barriers and benefits; subjective norms; knowledge; and so forth (World

    Bank, 2013b). 

    Furthermore, McGuire (McGuire, 1984) identifies five communication components

    for successful communication. These include: credibility of the message source;

    message design; delivery channel; intended audience; and intended behaviour (see

    also (Clarke, 1999)).

     We are interested to identify communication interventions, targeted at individuals,

    groups (including social and other networks), or communities/populations, which

    involve strategies (that is, inputs) with single or multiple media delivery channels.

    For example, the health objective may be to reduce infant mortality (e.g., an

    intermediate to long term health outcome), where messages are directed at mothers

    and are delivered using different communication strategies in different programmes.

    One strategy may involve interpersonal messaging only; another may involve

    interpersonal messaging and a poster campaign; a third may include the same

    elements plus advocacy through key networks. Such communication strategies have

     been studied, particularly in relation to reviewing alternative strategies to improve the

    performance of health workers (Rowe, 2011, 2013).1 

    1.4    WHY IT IS IMPORTANT TO DO THIS REVIEW

    There is a lack of clear synthesised evidence on the effectiveness of communication

    strategies of social marketing health programmes. It is unclear which communication

    strategies are most effective as assessed by changes in health and welfare outcomes,

    1http://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/res

    ources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20[Compatibility%20Mode].pdf  

    http://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdfhttp://obssr.od.nih.gov/scientific_areas/translation/dissemination_and_implementation/DI2011/resources/4B%20Rowe%20Reviews%20of%20Emerging%20Issues%20%5bCompatibility%20Mode%5d.pdf

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    as well as behaviour change and/or maintenance. There is a need to provide evidence

    on what facilitates effective and persuasive messaging in different communication

    interventions, which often brings together a mix of strategies (such as public advocacy

    and public relations; awareness; mobilisation; information and education; and

    advertising, promotion, and incentivisation) across a range of public health

    programmes in LMICs (Noar et al., 2009).

    Previous reviews to date conducted specifically on behaviour change communication

    (BCC) interventions, and their outcomes, have several limitations. First, they have

    focused on very specific topics such as: condom use (Sweat et al., 2012); HIV/AIDS

    (Noar et al., 2009); uptake of HIV/STI testing in men who have sex with men (Wei et

    al., 2011); alcohol (Moreira, Smith, & Foxcroft, 2009); hand hygiene (Mah et al.,

    2008); bicycle helmet use (Spinks et al., 2005; Royal et al., 2007); and preventive

    cardiology, sexual health, and substance use (Jepson et al., 2010). Second, previous

    reviews have examined a single, specific type of communication channel, particularly

    mass media (Bala, Strzeszynski, & Cahill, 2008; Bertrand et al., 2006; Grilli, Ramsay,

    & Minozzi, 2002; Leavy et al., 2011; Lecouturier et al., 2010; Marcus et al., 1998; Noar

    et al., 2009) and campaigns (Evans et al., 2008; Snyder, 2007). Third, some prior

    reviews have restricted their search to the highest quality study designs such as

    randomised controlled trials (RCTs) and cluster randomised controlled trials

    (Moreira et al., 2009). Fourth, although many of these reviews did not exclude LMICs,

    they nonetheless did not focus on LMICs. Fifth, previous reviews have neither

    explored the theoretical basis nor the mechanism of action of the interventions,

     whereas this review seeks to understand mechanisms of action by exploring potential

    mediators of behaviour such as knowledge, intention, self-efficacy and attitudes.Finally, there are a couple of protocols registered with the Cochrane Public Health

    Group that may overlap, to some degree, with this review but these reviews are

    focussed on specific topics such as oral health in children (de Silva-Sanigorski et al.,

    2012) and dietary behaviour in children and adolescents (Ganann et al., 2010).

     A review was undertaken in 2003 by PSI (Population Services International) of health

     based social marketing research (Department for International Development, 2003).

    The evidence base was defined through systematic review methodological procedures

    of the published literature documenting the effectiveness of social marketing availableon PubMed as well as unpublished PSI papers. The review resulted in the

    identification of 87 studies, which almost exclusively were related to HIV/AIDS,

    maternal and child health (including malaria interventions), and family planning and

    reproductive health. The review evaluated the effectiveness, efficiency and equity of

    social marketing programmes presented in the papers. Effectiveness of social

    marketing appeared clear based on strong evidence of a positive relationship between

    social marketing interventions and changes in product and service use as well as non-

    product related behaviours. The underlying process of such changes involves the areas

    of opportunity, ability and motivation as key determinants of health behaviours. On

    the other hand, recurrent observation of substitution as well as halo effects supported

    the claim of efficiency of social marketing interventions. Only in terms of equity, the

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    evidence base is more mixed, due mainly to differences in the statistical choices of

    study authors. More data is therefore required for it to be assessed properly.

    Despite these encouraging results, the review also demonstrated the gaps in the

    knowledge base about social marketing, and in particular in terms of:

     

    Guidance on the design of interventions, projects, and programmes;  Evidence of the rates of change at which targeted behaviour practices occur;

      Effectiveness of different levels of intensity/frequency;

      Effectiveness and efficiency of different marketing mixes as behaviour

    changes within a population;

      Long term effect on health behaviours; and

      Role of the price as a potential barrier to continued use of products and

    services.

    The major investment made by the international community in the communicationcomponent of global public health and development programmes, along with an

    increasing scientific literature, illustrate the importance accorded to this component

    – and hope in its effectiveness (Obregon & Waisbord, 2012). However, more evidence

    on its processes and best practices is needed.

    This review will address the gaps identified in the earlier PSI study and Department

    for International Development (DFID) review discussed above and will focus

    specifically on evidence from studies that have used BCC strategies in an intervention

    underpinned by social marketing principles.

    There is an increasing demand from policy-makers and funders for rigorous evidence

    for the impact of BCC projects on health behaviours and health outcomes and on

    market efficiency (Dhaliwal & Tulloch, 2012). This is driven by several factors:

       A significantly increased emphasis on evidence-based policy and funding

     within the international development sector as a whole, and thus on the

    importance of rigorous impact evaluation (UNICEF, 2005);

       A linked increase in the importance placed by donors (such as DFID and

    USAID, United States Agency for International Development) as well as

    NGOs on cost-effectiveness and value for money in the context of increased

    public scrutiny of funding for overseas aid and pressure on philanthropic

     budgets (Fowler, 2013);

      Scepticism in some quarters about the effectiveness of mass media behaviour

    change campaigns, given the lack of robust evidence, exacerbated by an

    impression that some BCC campaigns (for example, promoting condom use)

    have not always been effective; and

      Increased interest and funding in markets for the poor and underserved

    (Heierli, 2009; Bloom et al., 2014).

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    This review will focus on those studies that have specifically used single and multi-

    channel communication strategies in social marketing health programmes as defined

     by at least five of the eight underlying NSMC criteria mentioned in Section 1.1 above.

    The review will consider social marketing programmes from all LMIC health related

    sectors.

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    Objective of the review

    The overall objectives of the review are to assess the effectiveness of communication

    strategies incorporated in social marketing, on behaviour changes and/or

    maintenance, and health and welfare outcomes in LMICs.

    Primary objectives

    1)  To assess the effectiveness of communication strategies and the impact of such

    “messages’’ that are most used to underpin communication strategies through

    theoretical models of behaviour change and/or maintenance and social marketing

    strategies (that is, message impact); and

    2)  To assess the effectiveness of such communication strategies on health outcomes

    (prevalence, morbidity and mortality).

    Secondary objectives

    The following secondary objectives will be addressed, when available among includedstudies, in a narrative review:

    3)  To assess the barriers, mediators and moderators which significantly influence the

    impact of communication strategies on health behaviour change and/or

    maintenance;

    4)  To review the convergence of tools/technologies and channels which have been

    most used in communications for social marketing programmes. What evidence

    and potentially on-going research is available to support what is the best

    combination of tools and how and when should these be used (while keeping inmind that it may not always be evident for authors of studies involving complex

    interventions to identify exactly which tool, or combination of tools, yields the

    most favourable outcomes);

    5)  To review the principles and approaches used in communication design and

    evaluation, particularly the methods or theories used for: effective messaging;

    persuasiveness and information processing; credibility of programme and spokes

    people; and message design; and

    6) 

    To identify important evidence gaps in communication strategies.

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    to): statistical matching (for example, propensity score matching); and regression

    adjustment (for example, difference-in-differences, estimation, and variable selection

    models) (Waddington et al., 2012).

     With the breadth of different study designs within the inclusion criteria, any meta-

    analysis to evaluate the effect size(s) will be appropriately sub-grouped by study

    design (in addition to other PICO components –  participants, interventions,

    comparisons, outcomes, including by health condition) in order to minimise biases

    that could occur from combining studies of multiple types; further explanation of

    analyses are presented in Sections 3.3 and 3.4.

    3.1.2  Participants

    Participants will include targeted populations or communities, including social

    networks, and/or individuals in low- and middle-income countries (LMICs) of any

    age, gender, education, socio-economic status, or health conditions, who are eitherthe direct recipient of the health treatment product or service, the carer, or those in

    positions to administer or provide a treatment, product or service.

    3.1.3  Interventions

    Interventions would include all communication strategies in social marketing health

     behaviour change and maintenance programmes (which could also include those

    among the private sector) which agree with a modified version of at least five of the

    eight NSMC criteria that use communication inputs and channels designed to

    influence voluntary behaviour of target audiences (NSMC, 2010). The strategiescould relate to any product and/or service, or variation of these, promoted as part of

    the health programme.

    These criteria include:

    1) Behaviour change and/or maintenance: the intervention seeks to change (or

    maintain, in the case of positive behaviour adoption at baseline; for example,

    exclusive breast feeding may be an initial behaviour adoption but then it is often not

    always sustained for the recommended period) behaviour and has specific measurable

     behavioural objectives;

    2) Consumer research: formative research is conducted to identify consumer

    characteristics and needs, including their view of the recommended behaviour and

     what they see as constraining and facilitating factors in terms of implementing the

     behaviour. Interventions are pre-tested with the target group;

    3) Segmentation and targeting: different segmentation variables are used and a

    strategy is tailored to the segments;

    4) Marketing communication mix: the intervention must consist of communications

    (for example, mass media, personal selling, advertising, community mobilisation, or

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    public relations) plus at least one ‘P’ (from product, price, place, or promotion) or ‘C’

    (from consumer need/want/desire, cost, convenience, and communication);

    5) Exchange: the intervention considers what will motivate people to engage

     voluntarily with the intervention and offers them something beneficial in return,

     whether that is intangible or tangible, and whether the benefits are of value to the

    consumer (for example, insecticide treated bed nets are beneficial, but are these

     benefits perceived by the consumer as of value to them?);

    6) Competition: the intervention considers the appeal of competing behaviours

    (including the current behaviour) and uses strategies to decrease competition;

    7) Theory: the intervention uses behavioural theories to understand human behaviour

    and to build programmes around this understanding; and

    8) Customer orientation: the intervention attaches importance to understanding from

     where the customers are starting, their knowledge, attitudes and beliefs, and the social

    context in which they work.

    The intervention setting should be a developing country defined as a country bearing

    the World Bank designation of a low income, lower middle income, or upper middle

    income economy (World Bank, 2012).

    3.1.4  Comparisons

     Any comparisons will be included, both inactive and active controls including

    comparisons between different types of medium of communications.

    Comparisons would include:

      Baseline or adjusted baseline;

      Communication strategies, which can be comprised of at least one different

    type of communication method/channel;

      Use of different communication channels and their attributes including

    persuasiveness and information processing and message design and

    interactivity; and

      Different characteristics of social marketing policy as identified through the

    four “P”s (including, for example, differentiation in pricing, place of

    delivery and organisational provider, products and promotion), or the four

    “C”s (including, for example, differences in consumer

    needs/wants/desires, costs, conveniences to obtain the product or service,

    and communications).

     With the possible comparisons that could exist in evaluating effect sizes among

    studies of the same study design, further sub-groups will be defined to meta-analyse

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    those studies with similar comparisons in order to minimise biases that could occur

    from combining studies containing varying comparisons; further explanation of

    analyses are presented in Sections 3.3 and 3.4.

    3.1.5  Outcomes

    Due to the nature of the interventions, only the primary outcome will form part of theeligibility criteria. As seen in Figure 1, outcomes can occur in the short term, as well

    as in the more intermediate to long term. In some cases, outcomes can be both short

    and intermediate-to-long term in nature.

    Primary  

     A change in behaviour, and/or sustained behaviour change over time, targeted by the

    intervention, which could also include the adoption or sale of a service or product

    (that is, change in, or maintenance/uptake of, demand of a service or product). This

    may be objectively measured/observed or self-reported. In order to measure

    sustainability, or maintenance, of a behaviour change (or an initial positive behaviour

    adoption), the outcome would need to be measured for at least 6 months or longer

    (Prochaska & Velicer, 1997).

    Secondary

     Any of the following health, welfare, and cognitive outcomes will be identified from

    included studies, when available, and assessed narratively.

    Health outcomes:

      Prevalence and/or incidence;

      Indicators of morbidity and/or severity of morbidity; and

      Indicators of transmission, including change in transmission rate (for

    example, change in infected vectors).

     Welfare outcomes:

     

    Economic

    o  Income (change in monetary income);

    o  Labour productivity (for example, change in working hours, ability

    to work a “standard work day”, or to undertake more demanding

     work e.g. heavier work or increased production, including

    agricultural production for the same hours of work); and

    o   Voluntary leisure time;

      Social

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    o  Change in social relations (for example, measures of community

    inclusion/exclusion, measures of stigma e.g. earnings,

    employment, marriage status as compared with “health y people”);

    and

      Environmental

    o   Water and air quality.

    There are also intermediaries that assist the assessment of progress toward achieving

    a primary outcome of behaviour change, or a secondary health and welfare outcome.

    Intermediaries will be considered only if the aforementioned primary outcome is

    identified within a study. Intermediaries include the following:

    Cognitive outcomes:

    o  Knowledge (for example, awareness of the disease, knowledge of

    disease risk and realism of risk perception, and knowledge ofprivate and public benefits of the health intervention);

    o   Attitudes and intentions to change; and

    o  Self-efficacy (that is, a person’s belief in their capacity to carry out

    a specific action).

     Adverse outcomes may also be reported throughout the studies, which we will include

    in this review.

    Intermediate outcomes will be collected along the causal chain and may form part of

    the contextual and background information of the study.

    Based on the PICOS components defined above, an example of a study that meets the

    eligibility criteria for inclusion is Pattanayak et al. (2009). The intervention reported

     by the authors consisted in a community-led total sanitation approach aiming to

    empower local inhabitants by not simply providing latrines but also fostering

    discussions and reflexions to change knowledge, attitudes and practices. The

    development of the campaign was informed by in-depth interviews and focus groups

     with the targeted audience and key informants. Such formative research suggested

    the importance of key notions such as privacy, dignity and safety benefits, thus going beyond a simply medical approach and encompassing social and cultural dimensions.

    Social mobilization was fostered through a variety of intervention tools and channels,

    including three community-based activities: a community walk, a participatory

    mapping exercise, and group discussions. The planning and evaluation of the

    intervention makes use of other key social marketing concepts including the

    marketing mix approach: price, product, placement and promotion.

    On the contrary, Khan et al. (2012) is an example of a study that does not meet

    inclusion criteria. Although this study assesses a behaviour change communication,

    it does not meet any of the following social marketing criteria: consumer research,

    customer orientation, exchange, segmentation and targeting and therefore does not

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    reach the minimum five out of the eight criteria listed previously. Furthermore, the

    communication is limited to a single booklet, which is not accessible to illiterate

     women, thus reducing the reachable audience.

    3.2   SEARCH METHODS FOR IDENTIFICATION OF STUDIES

    3.2.1  Electronic searches

    The search will be performed in the following electronic databases:

    i.  CENTRAL, The Cochrane Central Register of Controlled Trials (latest

    issue);

    ii.  MEDLINE (Ovid SP) (1960 to date);

    iii.  EMBASE (Ovid SP) (1960 to date);

    iv.  PubMed;

     v.  PsycINFO (Ovid SP) (1960 to date);

     vi.  ERIC (Ovid) (1960 to date);

     vii.  CINAHL (Ovid) (1960 to date);

     viii.  Chinese Social Science Citation Index; 

    ix.  Indian Citation Index; 

    x.  Interred educational search engine; 

    xi.  Global Health (Ovid) (1960 to date);

    xii.   WHOLIS (1960 to date);

    xiii.  LILACS (1960 to date);

    xiv. 

    SCIRUS (1960 to date);

    xv.   Web of Science (1960 to date);

    xvi.   ASSIA (ProQuest) (1960 to date);

    xvii.  HMIC (Health Management Information Consortium)

    xviii.   WHO nutrition databases

    (http://www.who.int/nutrition/databases/en/) 

    xix.  Social Science Index

    http://en.wikipedia.org/wiki/Chinese_Social_Science_Citation_Indexhttp://en.wikipedia.org/wiki/Indian_Citation_Indexhttp://en.wikipedia.org/wiki/Interred_educational_search_enginehttp://www.who.int/nutrition/databases/en/http://www.who.int/nutrition/databases/en/http://www.who.int/nutrition/databases/en/http://www.who.int/nutrition/databases/en/http://en.wikipedia.org/wiki/Interred_educational_search_enginehttp://en.wikipedia.org/wiki/Indian_Citation_Indexhttp://en.wikipedia.org/wiki/Chinese_Social_Science_Citation_Index

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    xx.  OVID HealthStar

    xxi.  Open Grey

    xxii.  Sociofiles

    xxiii. 

    HINARI

    xxiv.  Scopus

    xxv.  Social Care Online

    3.2.2  Searching other resources

     We will also search reference lists of included studies and related reviews.

    In addition, we will search the grey literature using Google Scholar.

    The following document repositories of organisations will also be searched,

    throughout which we will use broad search terms such as ‘social marketing’  and

    ‘communication’:

    i.  Population Service International (http://www.psi.org);

    ii.  U.K. Department for International Development

    (http://www.dfid.gov.uk);

    iii. 

    U.S. Agency for International Development (http://www.usaid.gov);

    iv.  IDEAS/RePEc (http://ideas.repec.org);

     v.  3ie impact evaluation (http://www.3ieimpact.org);

     vi.  JHPIEGO (http://www.jhpiego.org/en);

     vii.  Family Health International (FHI) (http://www.fhi.org/en/index.htm);

     viii. 

    Population Council (http://www.popcouncil.org);

    ix.  The British Library for Development Studies;

    (http://www.blds.ids.ac.uk);

    x.   Asian Development Bank (http://www.adb.org);

    xi.   Australian Aid Agency (http://www.ausaid.gov.au/Pages/home.aspx);

    xii.  Canadian International Development Agency

    (http://www.acdi-cida.gc.ca/home);

    http://www.psi.org/http://www.dfid.gov.uk/http://www.usaid.gov/http://www.3ieimpact.org/http://www.jhpiego.org/enhttp://www.fhi.org/en/index.htmhttp://www.popcouncil.org/http://www.blds.ids.ac.uk/http://www.blds.ids.ac.uk/http://www.popcouncil.org/http://www.fhi.org/en/index.htmhttp://www.jhpiego.org/enhttp://www.3ieimpact.org/http://www.usaid.gov/http://www.dfid.gov.uk/http://www.psi.org/

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    xiii.  Swedish Development Agency (http://www.sida.se/English);

    xiv.  Danish Development Agency (http://um.dk/en/danida-en);

    xv.  Japan International Cooperation Agency (http://www.jica.go.jp/english);

    xvi. 

    Japan Bank for International Cooperation (http://www.jbic.go.jp/en);

    xvii.   World Bank (Office of Evaluation and Development)

    (http://go.worldbank.org/1F1W42VYV0);

    xviii.  Pan American Health Organization (http://www.paho.org);

    xix.   World Health Organization (http://www.who.int/en);

    xx.  United Nations (UNAIDS (http://www.unaids.org/en), UNICEF

    (http://www.unicef.org), UNEP (http://www.unep.org), UNDP(http://www.undp.org), UN-HABITAT (http://www.unhabitat.org), and

    UNRISD (http://www.unrisd.org));

    xxi.  Inter-American Development Bank (http://www.iadb.org);

    xxii.   African Development Bank (http://www.afdb.org);

    xxiii.  Red Cross (http://www.redcross.org);

    xxiv.  Christian Aid (http://www.christianaid.org.uk);

    xxv.  Oxfam (http://www.oxfam.org.uk);

    xxvi.   African Medical and Research Control (http://www.amref.org);

    xxvii.  Centers for Disease Control and Prevention (http://www.cdc.gov);

    xxviii.  Futures Group (http://futuresgroup.com);

    xxix.  Manoff Group (http://manoffgroup.com);

    xxx.  Centre of Excellence for Public Sector Marketing (CEPSM)

    (http://cepsm.ca.home);

    xxxi.  Rescue Social Change Group (http://rescuescg.com);

    xxxii.  Strategic Social Marketing Ltd. (http://www.strategic-social-

    marketing.vpweb.co.uk);

    xxxiii.  Social Marketing Services Inc. (http://www.socialmarketing

    servive.com);

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    xxxiv.  National Social Marketing Centre (NSMC) (http://www.thensmc.com);

    and

    xxxv.  DKT International (http://www.dkinternational.org/about-dkt).

     We will search the following theses and conference proceedings databases:

    i.  Index to Theses (http://www.theses.com); and

    ii.  Dissertation Abstracts

    (http://library.dialog.com/bluesheets/html/bl0035.html).

     We will search the following trial registers for on-going and recently completed trials:

    i.   WHO International Clinical Trials Registry Platform

    (http://www.who.int/ictrp/en/);

    ii.  Current Controlled Trials (www.controlled-trials.com);

    iii.  Clinical Trials (www.clinicaltrials.gov);

    iv.  Trials Register of Promoting Health Interventions (TRoPHI)

    (http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=5); and

     v.  Database of promoting health effectiveness reviews (DoPHER)

    (http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=2).

     We will also search the EPPI-Centre database of health promotion (Bibliomap)

    (http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=7).

    Given the focus of the review and the potential for studies to have been conducted and

    reported in other countries and languages, studies will not be excluded based on

    language of publication, and a translation will be performed when necessary.

    3.2.3  Search terms

    The following search terms will be used across marketing, communication, and

    setting domains:

    Marketing

    1 exp Marketing

    2 exp Social Marketing

    3 marketing.ab.ti

    4 (social adj3 market$).ab,ti.

    http://www.dkinternational.org/about-dkthttp://www.dkinternational.org/about-dkthttp://www.dkinternational.org/about-dkthttp://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=2http://eppi.ioe.ac.uk/webdatabases/Intro.aspx?ID=2http://www.dkinternational.org/about-dkt

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    5 behavio?r change.ab,ti.

    6 consumer research.ab,ti.

    7 audience segment$.ab,ti.

    8 market$ mix.ab,ti.

    9 customer orient$.ab,ti.

    Communication

    1 exp communication

    2 exp advocacy

    3 exp Consumer Advocacy/ or exp Patient Advocacy

    4 exp information dissemination

    5 information adj3 disseminat$.ab,ti.

    6 exp health promotion

    7 exp Education

    8 exp advertising

    9 adverti$.ab,ti.

    10 exp mass media

    11 mass media.ab.ti

    12 exp multimedia

    13 exp communications media

    14 exp information technology

    15 exp information

    16 drama?.ab,ti.

    17 "home visit*".ab,ti.

    18 play$.ab,ti.

    19 internet.ab,ti.

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    Setting

    43 exp Developing Countries

    44 low income countr$.ab,ti.

    45 low middle income countr$.ab,ti.

    46 developing countr$.ab,ti.

    47 middle income countr$.ab,ti.

    48 sub-saharan africa.ab,ti.

    49 southeast asia.ab,ti.

    50 latin america.ab,ti.

    51 south america.ab,ti.

    52 Exp Africa south of the Sahara

    53 Exp Asia, Southeastern

    54 Exp Latin America

    55 exp South America

    3.3   DATA COLLECTION AND ANALYSIS

     We will follow a three-stage approach to data collection and analysis. Using the

    aforementioned search strategy, Stage 1 will consist of identifying peer-reviewed and

    grey literature from databases and other sources listed in the previous section. These

     will be screened, first using titles and abstracts and then the full texts of potentially

    eligible studies, to ensure that articles meet the study inclusion criteria. In the full text

    screening, we will apply a restriction to include only those articles published after

    1960, as although “social marketing” was coined in 1971 (Kotler & Zaltman, 1971) the

    term and approach had already started being applied to health interventions by the

    1960s, especially in developing countries (Manoff, 1985; Walsh et al., 1993). However,

     we will not apply this restriction at the time of searching or initial screening of titles

    and abstracts due to the possibility of incorrect indexing of an article, particularly the

    date of publication.

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    In Stage 2, we will develop a matrix to facilitate the identification and categorisation

    of relevant social marketing communication strategies. The columns in the matrix will

    consist of common health conditions in LMICs that contribute to the global burden of

    disease while the rows will consist of the different strategies of the alternative

    communication strategies. These strategies relate to the inputs and channels outlined

    in Figure 1.

    In Stage 3, the definition and understanding of communication strategies will be

    informed by the matrix and refined as necessary.

    3.3.1  Selection of studies

     We will merge search results across databases and other resources, using the

    reference management software EndNote X5 (Thomson Reuters Corporation, 2010),

    and remove duplicate records of the same report. Two authors (ERS and LF) will

    independently examine titles and abstracts of records retrieved from the search. We will retrieve the full text of the potentially-relevant studies and assess their eligibility

    against the inclusion criteria. Multiple reports of the same study will be reviewed in

    order to determine if the study is eligible for inclusion, since oftentimes multiple

    publications regarding a single study may not always provide the study design and

    analysis information in each publication for that study. Authors will compare their

    inclusion and exclusion decisions and discuss any differing results, with unresolved

    disagreements about study eligibility evaluated by a third review author (LHG or JL),

     who will serve as a mediator.

    If any disagreements are not resolved, then we will place the article with those

    'awaiting assessment' and will contact the author(s) for clarification. We will also

    include any on-going trials if a study author(s) provides interim outcome data, or the

    final data, ahead of publication of their report. We will describe all the potentially-

    relevant excluded studies in the ‘Characteristics for Excluded Studies’ table along with

    reasons for exclusion. We will use an adapted PRISMA (Preferred Reporting Items for

    Systematic Reviews and Meta-Analyses) flow-chart to describe the study selection

    process (Schünemann et al., 2011).

    3.3.2 

    Data extraction and management

    For studies meeting the inclusion criteria, we will extract the PICOS characteristics

    (information on participants, interventions, comparisons, outcomes, and study

    designs) and present them in a table. The Appendix (in Section 7) provides a draft

    codebook of key constructs of interest for the data extraction. Two authors (ERS and

    LF) will independently extract relevant PICOS characteristics of all the included

    studies using a structured data collection/extraction form approved by the other team

    members; any disagreements will be resolved by referencing the original article or

    consulting, when necessary, with a third author (LHG). Any relevant missing

    information on the study(s) will be sought from the original author(s) of the article, if

    required. ERS will transfer the data from the extraction form to the Review Manager

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    software (The Cochrane Collaboration, 2012) while LF will confirm the accuracy of

    the entered data.  We will summarise extracted data in a ‘Characteristics of Included

    Studies’ table. 

    3.3.3   Assessment of risk of bias in included studies

    Two authors (ERS and LF) will perform independent assessments of the risks of biases within each study. For studies with a separate control group such as

    randomised controlled trials, non-randomised controlled trials, and controlled

     before-after studies, we will use the risk of bias criteria as suggested by the Cochrane

    Collaboration’s Effective Practice and Organisation of Care (EPOC) review group

    (Effective Practice and Organisation of Care Group, 2009). This judges the study

    against nine criteria related to: sequence generation; allocation concealment; baseline

    outcome measurements; baseline characteristics; incomplete outcome data; blinding

    of outcome assessments; contamination; selective outcome reporting; and other

     biases. For judging other biases, we will consider the following two criteria: use of valid and reliable outcome measurements; and funding sources. For each criterion,

    the risk of bias will be judged as low, unclear, or high.

    For studies that use an interrupted time series (ITS) design, we will assess the risk of

     bias using the following domains as recommended by EPOC (Effective Practice and

    Organisation of Care Group, 2009): 1) the intervention being independent of other

    changes; 2) sufficient data points to enable statistical inference; 3) the intervention

     being unlikely to affect data collection; 4) blinding of outcome assessors to

    intervention allocation; 5) incomplete outcome data being adequately addressed; 6)

    selective reporting of outcomes; and 7) other risk of bias related to validity and

    reliability of outcome measures and funding sources.

     We will seek guidance from the IDCG (International Development Coordinating

    Group) secretariat to assess the risk of bias in studies that have used multiple

    statistical analyses (IDCG, 2012).

    In all cases, two authors (ERS and LF) will independently assess the risk of bias of

    included studies, with any disagreements resolved by discussion, and with

    consultation of a third review author (LHG) as a mediator. As necessary and wherepossible, we will contact study authors for additional information about the included

    studies, or for clarification of the study methods. We will incorporate the results of

    the risk of bias assessment into the review through a ‘Risk of Bias’ table, and a

    systematic narrative description and commentary about each of the elements, leading

    to an overall assessment of the risk of bias of included studies and a judgment about

    the overall internal validity of the review’s results. 

    The correlation between these risks of bias measures and the effect sizes will be

    examined. And a sensitivity analysis will be conducted using one or more risk of bias

    scores as a moderator.

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    3.3.4   Assessment of statistical power of included studies

    For any included study that is not eligible for a meta-analytic synthesis of estimating

    pooled effects, we will obtain the statistical power of the study to detect pre-

    established significant effect magnitudes from the published report (IDCG, 2012). If

    this is not available, then we will calculate the power of the study (post-hoc) for the

    point estimate of the effect based on the primary outcome. This will be based on the

    assumption that the sample size is sufficient to detect an optimal difference in

     behaviour change outcome with 90% power at the 0.05 significance level.

    3.3.5  Measures of treatment effect

     We will compare characteristics of included studies to assess the feasibility of

    conducting a meta-analysis. Only those studies that are deemed homogeneous based

    on similar PICOS elements, including cultural and population-specific characteristics

    (that is, it may be unrealistic to conclude that the effectiveness of the sameintervention strategy/mix of strategies is equivalent among varying cultures), will be

    meta-analysed. For dichotomous outcomes of included studies, we will report risk

    ratios and corresponding 95% confidence intervals. For continuous data among

    studies that assess the same outcome measure, we will estimate mean differences (for

    studies using the same scale) and standardised mean differences (for differences in

    scale) between groups, along with their corresponding 95% confidence intervals.

    Since included studies are likely to come from heterogeneous epidemiological and

    socioeconomic settings, and true effect sizes are expected to vary, a random effects

    meta-analysis will be employed, if feasible to combine similar studies by subgroups.

    For controlled before and after studies, we will report the relative percentage change

    post intervention and standardised mean differences, along with their associated 95%

    confidence intervals.

     Where follow-up data were collected at different time periods, we will report results

    taken from the furthest points in time relative to the intervention (Deeks et al., 2011).

    For interrupted time series studies, we will report the following estimates, and their

    95% confidence intervals, from regression analyses which adjust for autocorrelation:

    (i) change in level of the outcome at the first point after the introduction of the

    intervention (immediate effect of the intervention); and (ii) post-intervention slope

    minus the pre-intervention slope (long term effect of the intervention) (Brennan et

    al., 2009).

    3.3.6  Unit of analysis issues

    If a study has multiple intervention arms, but only one that would fulfil our inclusion

    criteria, then we would compare this arm with the least active or inactive arm. We

     will, however, list all other arm(s) that were not used for comparison in the report.

     Where a study has more than one active intervention arm, data from the appropriate

    arms for each of the main comparisons will be extracted. If more than one treatment

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    arm is relevant for a single comparison, then data from all appropriate arms will be

    included in that comparison.

    In studies where the effects of clustering have not been taken into account (for

    example, by using multilevel modelling), we will correct for this unit of analysis error

     by adjusting the studies’ corresponding standard errors and confidence intervals, by

    a factor including the intra-class correlation coefficient (ICC), if provided in papers,

    or using a published estimate of the ICC for different interventions and outcomes

    (Ukoumunne et al., 1999) as suggested by (Higgins et al., 2011).

    3.3.7  Dealing with missing data and incomplete data

    For any missing data within included studies, we will contact the study authors in an

    effort to obtain this missing information (for example, number of participants in each

    group, outcomes, and summary statistics). If the standard deviations (SDs) of

    continuous outcome data are missing, then we will attempt to calculate them usingother reported statistics, such as 95% confidence intervals, standard errors, or p-

     values. If these are unavailable, then we will contact the author(s) in an effort to obtain

    them. We will use an intention-to-treat (ITT) analysis (Higgins et al., 2011).

    3.4   DATA SYNTHESIS

    3.4.1  Quantitative Synthesis

    The studies’ characteristics based on the PICOS components will be compared to

    determine whether studies can be combined with a meta-analysis based on relatively

    little or moderate clinical heterogeneity, as determined by experts with knowledge of

    communication strategies embedded within social marketing programmes. First,

    studies will be grouped according to health condition and primary outcome(s) within

    that condition. Next, studies will be assessed on the criteria of intervention(s),

    comparison(s), and participants within a given health condition to determine whether

    (or which) studies can be combined based on relatively low or moderate clinical

    heterogeneity of these criteria (e.g., see Section 3.4.1.2 for some of the intervention

    components that will be assessed). Experts with knowledge of communication

    strategies embedded within social marketing programmes (for example, one of our

    co-authors at Development Media International, some of the Key Influencers as

    identified in our Policy Influence Plan) will be contacted to review these criteria to

    assess the level of clinical heterogeneity, hence advising whether to combine

    potentially similar studies in a meta-analysis. Grouped studies will then be assessed

     by study design and only those with the same study design will be combined into a

    meta-analysis. Thus, only those studies that are deemed by the experts as

    homogeneous based on similar PICOS elements, including cultural and population-

    specific characteristics (that is, it may be unrealistic to conclude that the effectiveness

    of the same intervention strategy/mix of strategies is equivalent among varying

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    cultures), will be meta-analysed. Where appropriate, effects will be synthesized for

    short, intermediate, and long term outcomes along the causal chain (IDCG, 2012).

    If suitable numerical data are not available and/or if a meta-analysis is not

    appropriate, as in cases where the included studies are too clinically heterogeneous to

    combine, we will perform a narrative synthesis. We will refer to the narrative

    synthesis framework to guide this process (Rodgers et al., 2009). In particular, we will

    use the following steps:

      Develop a preliminary synthesis by grouping the included studies by the type

    of health condition;

      Describe Participants, Interventions, Comparisons, and Outcomes (PICO

    elements) along with the reported findings for each of the included studies;

      Explore the relationships between characteristics of individual studies and

    their reported findings, as well as those between the findings of different

    studies;

      Describe the moderators as well as the mediators that would have an impact

    on the intervention effects. Depending on the availability of data from

    included studies, we will also explore and report the impact of the

    interventions on specific population groups such as those belonging to low

    socioeconomic status, children, women, or older people; and

     

    Use the summary of the risk of bias of an outcome across studies to judge therobustness of the evidence.

     We will perform the statistical analysis using RevMan version 5.2 (The Cochrane

    Collaboration, 2012). We will adhere to the statistical guidelines in (Higgins et al.,

    2011).

     We will use the GRADE system to assess the quality of the overall evidence. We will

    construct a ‘Summary of Findings’ table that will include  the magnitude of the effect

    of the interventions, and a summary of available data for primary and secondary

    outcomes (Schünemann et al., 2011).

    3.4.1.1   Assessment of heterogeneity

     When a meta-analysis is possible, we will assess statistical heterogeneity through

     visual inspection of forest plots, by assessing the overlap of 95% confidence intervals

    for estimated intervention effects across studies (i.e., with poor overlap indicative of

    statistical heterogeneity), and through assessment of heterogeneity statistics, such as

    I2 and the Chi-square significance test for heterogeneity. Since the Chi-square test

    may have lower statistical power for a smaller number of combined studies or with

    studies of small sample sizes, a 0.1 significance level will be used rather than the

    standard 0.05 level, with significant results indicative of statistical heterogeneity

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    (Deeks et al., 2011). As we will be using a random effects meta-analytic model, we will

    also report the between study variability, tau-squared (τ 2).

    3.4.1.2  Investigation of Heterogeneity

     We will investigate whether findings differ according to key intervention components

    or potential contextual mediators as listed below (Baron & Kenny, 1986; Bauman etal., 2002):

      Theoretical models used;

      Mono or multi intervention and intervention combinations;

      Duration of intervention, its frequency and intensity;

      Channel(s) of delivery (fore example, media, face-to-face, electronic, and so

    forth);

      Level of interaction allowed by intervention;

     

     Audience health status;  Product or service type;

      Level and attributes of segmentation;

      Country income level (that is, ‘lower middle income countries’, ‘higher middle

    income countries’ and ‘low income countries’); and

      Source of funding and/or implementation (that is, industry, aid, national).

    In addition, we will collect information on sub-groups of interest, including

     vulnerable groups, according to PROGRESS-plus (place of residence, race/ethnicity,

    occupation, gender, religion, education, socioeconomic status, social capital, age,

    disability, and sexual orientation) categories (Kavanagh et al., 2009).

    If sufficient studies are available for a given outcome and potentially important

    moderators are identified in the review through a sub-group meta-analysis, then we

     will perform meta-regression to estimate the independent effects of these covariates

    on effect (IDCG, 2012). This would be performed in the statistical software package R

    (R Core Team, 2013).

    3.4.1.3  Sensitivity Analysis

     We will perform sensitivity analyses (using the criteria discussed in the ‘Assessment

    of Risk of Bias in Included Studies’ section, and as recommended by Effective Practice

    and Organisation of Care Group, (2009)) including:

      Exclusion of studies with a high risk of attrition bias, that is, incomplete

    outcome data; and

      Exclusion of potentially influential outliers (that is, large studies with

    excessively large or small effect sizes that may heavily influence the mean

    effect size).

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     At the end we  will apply 3ie’s quality appraisal of systematic reviews checklist2  to

    check for the completeness of all the review methods and to improve clarity in the

    final report.

    3.4.1.4  Assessment of Publication Bias

     We will evaluate funnel plots for asymmetry (provided there are at least ten includedstudies in the meta-analysis). Funnel plots will be used as a means of investigating

    small study effects that may have occurred due to the potential existence of reporting

     biases (for example, small study bias). Tests of funnel plot asymmetry may also be

    used to examine whether the association between estimated intervention effects and

    a measure of study size is greater than might be expected to occur by chance, and to

    add further consideration to the visual inspection of the funnel plot (Sterne et al.,

    2011). We will also consider other reasons for possible funnel plot asymmetry such as

    true heterogeneity or the methodological quality of included studies.

    3.4.2  External Validity

    In order to explore external validity of the review, we will present results in terms of

    relative and/or absolute effects and discuss the implications of differences in absolute

    or relative effects for different contexts such as related to moderators and PROGRESS

    plus categories as listed under the Assessment of Heterogeneity section. In addition,

     we will use the GRADE system to assess the quality of the evidence, the magnitude of

    effect of the interventions, and the available information on the primary and

    secondary outcomes. Results will be presented in a ‘Summary of Findings’ table

    (Schünemann et al., 2011).

    2http://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabas

    e.pdf  

    http://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdfhttp://www.3ieimpact.org/media/filer/2012/05/07/quality_appraisal_checklist_srdatabase.pdf

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    Timeline

    Date Event

    1 March 2013 Preliminary Protocol submitted to Campbell Collaboration

    14 April 2013 Comments received from Campbell Collaboration

    21 May 2013 Final Protocol submitted to Campbell Collaboration

    15 October 2013 Submission of draft report to Campbell Collaboration

    15 November 2013 Comments received from Campbell Collaboration

    31 December 2013 Submission of final paper to Campbell Collaboration

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     Acknowledgements

     We would like to acknowledge support and assistance from:

      International Initiative for Impact Evaluation (3ie) who are funding this

    review;

      Tim Reeves, Medical Research Support Librarian at Imperial College

    London, for his advice on devising the search strategies;

      The review Advisory Group members for their feedback on a draft of this

    document; and

      Campbell peer review groups.

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