preliminary findings of an individually-tailored adaptive ...preliminary findings of an...

Preliminary Findings of an Individually-Tailored

Adaptive Intervention to Manage Perinatal Weight Gain

Exercise Psychology Laboratory

Annual Meeting of the Society of Behavioral Medicine

April 1 2016

Dr. Danielle Symons Downs, Professor of Kinesiology and OBGYN

The Pennsylvania State University

Symposium Objectives

• Describe individually-tailored,

intensively adaptive intervention for

managing perinatal weight gain

• Discuss preliminary findings from

Study 1

• Highlight key lessons learned in

preparation of Study 2



April 1 2016

The Problem


(Flegal et al., 2010 – JAMA, 303; 235-241)

(Haugen et al., 2014 – BMC Preg & Childbirth, 14; 201-211)

• Majority of women enter pregnancy

already overweight (OW 45%) or

obese (OB 30%)

• GWG in excess of guidelines

– OW 70%, OB 60%

• Elevates risks for maternal and

fetal complications

– GDM, preeclampsia, macrosomia

(CDCP, 2009; IOM, 2009; Linne et al., 2004; NRC, 2007)

IOM GWG Guidelines

Exercise Psychology Laboratory(CDCP, 2009; IOM, 2009; NCR, 2007)

Category Prepreg

BMI (kg/m2)

GWG

Range

Rates of GWG

2nd-3rd TRI

(M range in

lbs/wk)

Underweight < 19.8 28-40 1 (1-1.3)

Normal 19.9 – 24.9 25-35 1 (.08-1)

Overweight 25.0-29.9 15-25 0.6 (0.5-0.7)

Obese > 30.0 11-20 0.5 (0.4-0.6)

Very small amount of

weight gain per week

Managing GWG Should be Straight Forward?


+

• Review found 20% reduced risk of

high GWG with diet only, exercise

only, and diet + exercise

– largely among normal weight women

• Not consistent in OW/OB women

– OW/OB women have more trouble

adhering to diet and exercise rec’s

than NW women

– limited effectiveness

– recruitment & retention

(Muktabhant et al., 2015)

(Streuling et al., 2011; Sui et al., 2012; Choi et al., 2013)

R01 Research Aims

Weisman, C. S., Hillemeier, M. M., Symons Downs, D., Chuang, C. H., & Dyer, A. M. (2010).

Preconception predictors of weight gain during pregnancy: Prospective findings from the Central

Pennsylvania Women’s Health Study. Women’s Health Issues, 20, 126-132.Exercise Psychology Laboratory

1R01HL119245-01

• Aim 1: Establish feasibility of individually-tailored, intensively adaptive

intervention for managing GWG in OW/OBPW (2 studies)

• Aim 2: Use data collected from Aim 1 and control systems engineering to

build dynamical model

– adapt dosages and characterize effects of energy balance and planned/self-

regulatory behaviors (using m-health tools) on GWG

• Use model to develop an optimized intervention

– as effective and efficient as possible


April 1 2016

Conceptual Framework

Weisman, C. S., Hillemeier, M. M., Symons Downs, D., Chuang, C. H., & Dyer, A. M. (2010).

Preconception predictors of weight gain during pregnancy: Prospective findings from the Central

Pennsylvania Women’s Health Study. Women’s Health Issues, 20, 126-132.Exercise Psychology Laboratory

1R01HL119245-01

Dong, Y., Rivera, D. E., Thomas, D. M., Navarro-Barrientos, J. E., Symons

Downs, D., Savage, J. S., & Collins, L. M. (2012). A dynamical systems model

for improving gestational weight gain behavioral interventions. Proceedings of

the 2012 American Control Conference, Montreal, CN, 4059-4064.

Studies

• Study 1: Feasibility

– delivering components/dosages

– self-monitoring with m-Health tools

– measurement

– Included:

• 28 OW/OB pregnant women

• randomized to 7 dosages over 4 wk

• post individual interviews for user

acceptability


• Study 2: Proof of Concept

– implement criterion rule

– fully adaptive intervention

– intensive longitudinal data

– Will include:

• 30 OW/OB pregnant women

• randomization to INT vs CON

from ~8-12 wk-37 wk gestation

• biomarkers for maternal stress;

fetal growth and infant birth wt*

Result in:

Control systems engineering to build model

Develop optimized intervention to effectively/

efficiently manage GWG

Lead to:

Better simulation model

Inform necessary modifications

(intervention/measurement protocols)

1R01HL119245-01 *R56HL126799-01

Intervention Components

Exercise Psychology LaboratoryComponents: Evidence-based from model programs (DPP, Look AHEAD,

past GWG interventions, and PI research on promoting healthy behaviors in

pregnancy with the Theory of Planned Behavior (NIDDK 07586702).

1R01HL119245-01

Education• GWG/nutrition/EX guidelines

• GWG plotting

• Energy density, portion size, etc.

• EX benefits, safety, strategies

Goal-Setting• Principles, implementation intentions

• Healthy eating/EX plans

• Problem-solving/weekly feedback

Self-Monitoring

• Behaviors, feedback, overcoming

barriers

Active Learning

• Healthy eating/EX sessions

Intensive Longitudinal Data


Baseline Intervention Dosage Follow-up

Daily: Aria Scale, Jawbone/Actigraph

Weekly: MFP, Self-Report Measures

1R01HL119245-01

Weight, Height

GWG Attitudes/Knowledge

HE Behaviors, TPB, Cognitions

EX Behaviors, TPB, Cognitions

Self-Regulation Behaviors

Sleep Behaviors

Psychological Well-Being

Socio-demographic

Weight, Height

GWG Attitudes/Knowledge

HE Behaviors, TPB, Cognitions

EX Behaviors, TPB, Cognitions

Self-Regulation Behaviors

Sleep Behaviors

Psychological Well-Being

Socio-demographic

Study 2

Body Composition (Bod Pod)

Serum Blood Biomarkers

Cortisol (Urine)

Mobile Metabolism/RMR

Study 2

Body Composition (Bod Pod)

Serum Blood Biomarkers

Cortisol (Urine)

Mobile Metabolism/RMR

Study 2

Weekly: Cortisol, Perceived Stress, RMR

4-6 Weeks: Fetal Growth/Abnormalities

1R01HL119245-01 *R56HL126799-01

Healthy Mom Zone Study 1

Preliminary Findings


1R01HL119245-01

Study 1: Feasibility of Dosages


Baseline(week 1)

Intervention Dosage(weeks 2-5)

Follow-up(week 6)

AssessmentsDaily: Aria Scale, Jawbone/Actigraph

Weekly: MFP, Self-Report Measures Assessments

Dosage 1 Dosage 2 Dosage 3 Dosage 4 Dosage 5 Dosage 6 Dosage 7

1R01HL119245-01

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

2nd EX Session

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

2nd EX Session

3rd EX Session

Study 1: Results


Baseline(week 1)


Follow-up(week 6)




1R01HL119245-01

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

2nd EX Session

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

2nd EX Session

3rd EX Session

N = 28 Eligible, 22 completed dosage assignment

Study 1: Dosage Feasibility Results


Baseline(week 1)


Follow-up(week 6)




1R01HL119245-01

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

2nd EX Session

Education

Self-Monitoring

Food Scale

Goal-Setting

HE/EX Plans

HE Demo’s

EX Session

Self-Monitoring

Feedback

Meal Replacmt

2nd EX Session

3rd EX Session

N = 28 Eligible, 22 randomized, 18 completed (2 pregnancy losses prior to randomization; 4 lost to follow-up after screening, 4 drop-outs)

Participant Characteristics (Completed)


1R01HL119245-01

Wt

Status

AgeM (SD)

Gest Wk

Study Start*M (SD)

Pre-Preg

BMI* M (SD)

Weight Study

Start*M (SD)

GWG Study

StartM (SD)

OW

(n=12)

29.5

(5.9)

18

(4.5)

26.8

(1.5)

173.2

(17.8)

10.8

(9.1)

OB

(n=6)

29.3

(5.0)

13.3

(2.4)

33.5

(3.0)

210.8

(27.3)

5.9

(3.9)

* Significant group difference at p < .01; Variations in participant characteristics precludes individual

dosage examination

Study 1 Feasibility Results

• Identified threshold of “too much intervention” between dosage 6 and 7

– dropped 3rd on-site exercise session – integrated ‘at home’ sessions

• Protocol modifications

– revised screening protocol (e.g., wider BMI range, excluded smokers)

– increased efforts to recruit women into study sooner (~6-8 weeks gestation)

• Assessment Protocol

– dropped Supertracker and ASA-24 – women greatly disliked

– less than 5% missing data despite intensive data collection


1R01HL119245-01

Healthy Mom Zone Study 1

Challenges, Solutions, and Lessons Learned

in Preparation for Study 2


1R01HL119245-01

Retaining Participants Longitudinally

• Clinic OBGYNs encouraging

patients to join study

• Used feedback from Study 1

interviews to improve retention

and reduce burden

– revised instructions and developed

summary table (tasks & appt’s)

– developed PPT and video demo’s for

m-health tools

– adjusted compensation


1R01HL119245-01

Criterion Rule for Evaluating GWG


1R01HL119245-01

GWG

evaluation

meet GWG

goal:

stay the

course

exceed

GWG goal:

step-up

baseline

intervention

meet GWG

goal at study

entry get:

exceed GWG

goal at study

entry:

step-up

assess GWG in

4-week cycles

through delivery

Decision rule = evaluate GWG; dosage maintained if meet

GWG goal; dosage increased if exceed GWG goal. GWG

also a tailoring variable.

GWG

evaluationRecruit / Enter Study

10-12 weeks

gestation

Criterion Rule for Evaluating GWG

• Study 2: started recruitment sooner (~6-8 wk gestation)

• Include 2-wk acclimation period

– reduce burden (adjust to ILD schedule of measures), concerns about EX

• Adapt up after acclimation as needed


1R01HL119245-01

Recruit

(~6-8 wk)

Baseline

Measures Week

(on-site & home)

Acclimation

(2 weeks)

- on-site session

- education

- goals

- self-regulation

- ILD measures

GWG

Assmt

Above GWG

Step-up Dosage

Within GWG

Maintain Dosage

continue to evaluate every 3-4 wks

t (days)0 90 100 110 120 130 140 150 160 170

W (

lb)

145

150

155

142 lb

149.8 lb 153.9 lb

Dosage 3Predicted W (MFP-Actigraph(Evenson))Predicted W (MFP-Actigraph(Hooker))Predicted W (MFP-Jawbone)Measured WIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170

EI (k

cal)

0

1000

2000

3000

4000

EI MFPIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170

PA

(kca

l)

0

500

1000Actigraph (Evenson)Actigraph (Hooker)Jawbone

PA Measurement (ILD)


1R01HL119245-01

t (days)0 90 100 110 120 130 140 150 160 170 180

W (

lb)

160

165

170

175

157 lb

167.5 lb 175.7 lb

Dosage 3

Predicted W (MFP-Actigraph(Evenson))Predicted W (MFP-Actigraph(Hooker))Predicted W (MFP-Jawbone)Measured WIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170 180

EI (k

cal)

0

1000

2000

3000

4000

EI MFPIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170 180

PA

(kca

l)

0

500

1000

Actigraph (Evenson)Actigraph (Hooker)Jawbone

BMI = 25.2 kg/m2

Age = 36

GA @baseline = 17 weeks

BMI = 26.9 kg/m2

Age = 31


Correspondence of Actigraph & Jawbone for estimating kcal

(avg discrepancy over 4 weeks was 26 kcal)

Underreporting of Dietary Intake


1R01HL119245-01

• Energy intake back-calculation from the energy balance model

• Numerical approximation of derivative term using 2nd order centered difference:

• Also developed other approaches to EI estimation:

• Semi-physical identification using batch data to estimate systematic

underreporting of EI in the presence of noise despite missing data

• Kalman filtering approach for real-time EI estimation

• The results obtained from these three approaches are observed to be comparable

Add ACC reference

Degree of Underreporting in Study 1


1R01HL119245-01

Subject MFP Back Calculated EI IOM Guideline % Underreporting

1 2166 2518 3161 14.0%

2 2234 3003 3237 25.6%3 2349 2963 3237 20.7%4 1859 2701 3155 31.2%5 2457 2777 3155 11.5%6 2239 3886 3259 42.4%7 2010 2115 2795 5.0%8 2419 2953 3275 18.1%9 1793 2515 3187 28.7%

10 1477 2945 3216 49.8%11 1376 2543 3120 45.9%12 1534 3196 3214 52.0%13 1204 2626 3223 54.2%14 1793 2664 3155 32.7%15 1378 1968 3109 30.0%16 1358 2321 3181 41.5%17 2126 2476 3184 14.1% Values in kcal

Range from 5-54%100% underreported

Underreporting of Dietary Intake


1R01HL119245-01

BMI = 29.7 kg/m2

Age = 34


BMI = 25.2 kg/m2

Age = 36


t (days)0 90 100 110 120 130 140 150 160 170

W (

lb)

145

150

155

142 lb

149.8 lb 153.9 lb

Dosage 3Predicted W (MFP-Jawbone)Predicted W (Calc-Jawbone)Measured WIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170

EI (k

cal)

0

1000

2000

3000

4000

5000

EI MFPEI CalculatedIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170

PA

(kca

l)

0

500

1000

Jawbone

t (days)0 90 100 110 120 130 140 150 160 170

W (

lb)

170

180

190

200

187 lb

177.6 lb 185.5 lb

Dosage 1

Predicted W (MFP-Jawbone)Predicted W (Calc-Jawbone)Measured WIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170

EI (k

cal)

0

1000

2000

3000

4000

5000

EI MFPEI CalculatedIOM Recommendation

t (days)0 90 100 110 120 130 140 150 160 170

PA

(kca

l)0

500

1000

Jawbone

Less Significant Underreporting More Significant Underreporting

Add ACC reference

1600

1800

2000

2200

2400

2600

2800

12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40

Calo

ries

Weeks Gestation

Obese Participant

Vesco 30 Vesco 25 Vesco 20 IOM

Calorie Goals 1R01HL119245-01


Vesco et al. (2012). Contemporary Clinical Trials, 33, 777-785.

• IOM calories are based on energy needs for normal weight women

• Lack of guidance on EI for OW/OB women

• Explore use of calorie goal reduction (Vesco et al., 2012)

Calorie Goals


1R01HL119245-01

Vesco et al. (2012). Contemporary Clinical Trials, 33, 777-785.

Vesco 20% reduction

Vesco 25% reduction

Vesco 30% reduction

IOMMFP

ASA-24

Vesco Range


1R01HL119245-01

t (days)0 90 100 110 120 130 140 150 160 170

W (

lb)

170

180

190

200

187 lb

177.6 lb 185.5 lb

Dosage 1

Predicted W (MFP-Jawbone)Predicted W (Calc-Jawbone)Measured WIOM RecommendationVesco Range

t (days)0 90 100 110 120 130 140 150 160 170

EI (k

cal)

0

1000

2000

3000

4000

5000

EI MFPEI calculatedIOM RecommendationVesco Range

t (days)0 90 100 110 120 130 140 150 160 170

PA

(k

cal)

0

200

400

600

800

1000

Jawbone

BMI = 29.7 kg/m2

Age = 34


t (days)0 90 100 110 120 130 140 150 160 170 180 190 200

W (

lb)

170

175

180

185

190

195

170 lb

186.2 lb

196.1 lb

Dosage 2Predicted W (MFP-Jawbone)Predicted W (Calc-Jawbone)Measured WIOM RecommendationVesco Range

t (days)0 90 100 110 120 130 140 150 160 170 180 190 200

EI (k

cal)

0

1000

2000

3000

4000

5000

EI MFPEI calculatedIOM RecommendationVesco Range

t (days)0 90 100 110 120 130 140 150 160 170 180 190 200

PA

(k

cal)

0

200

400

600

800

1000Jawbone

BMI = 27.4 kg/m2

Age = 28


Safety Alerts for Study 2


1R01HL119245-01

• Weight loss

• Contraindications to EX

• Anemia

• Addition of Ultrasound protocol*

• 2 participants had U/S flagged

(fetus < 10%tile, low lying

placenta)

• immediate referral to OBGYN

• obtain MD consent to continue

participation

*R56HL126799-01

Conclusions & Next Steps


1R01HL119245-01

• Individually-tailored intervention

intense dosages to manage GWG

in OW/OB women appear feasible

• women liked intervention

components, enjoyed active

learning activities

• Study 2 fully adaptive intervention

• recruitment currently under way

• Goal to develop optimized

(effective and efficient)

intervention to manage GWG

Collaborative Team

• Dr. Jennifer S. Savage, Center for Childhood Obesity Research and Department

of Nutritional Sciences, The Pennsylvania State University

• Dr. Daniel E. Rivera, Control Systems Engineering Laboratory, School for

Engineering of Matter, Transport, and Energy, Arizona State University

• Drs. Linda Collins, Joshua Smyth, Barbara Rolls, Rick Legro, Jamey Pauli, Erica

Rauff, Diana Thomas, Yueng Dong, Brandi Rollins, Katie Balantekin

• Abigail Pauley, Lindsey Hess, Allen Kunselman, Courtenay Devlin, Penghong

Guo, Krista Leonard, Emily Hohman


Dr. Danielle Symons Downs

[email protected]

mailto:[email protected]

Funding

• Support for this work has been provided by the Office of Behavioral and

Social Sciences Research (OBSSR) of the National Institutes of Health, the

National Institute on Drug Abuse (NIDA), National Heart, Lung, and Blood

Institute (NHLBI) through grants R21 DA024266 (roadmap), K25 DA021173,

R01 HL119245-01, R56HL126799-01, USDA NIFA (#2011-67001-30117

Program A2121 Childhood Obesity Prevention Training Program), and PSU

State Social Science Research Institute


Dr. Danielle Symons Downs

[email protected]

mailto:[email protected]

preliminary findings of an individually-tailored adaptive ...preliminary findings of an...

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