Group 5Clinical Trial

Kirstie Campbell, Stephanie Hutchinson, Blaire Williams, Miranda Shaner, Billy Heath, Chris Payne, Chris Simmons,

Brandon Abbott, Nick Gordon, Rachae Graves, Josh Jackson, Anna Sampson, Stephanie Kelly, Sara Catlett, Marquiesha Hairston, Michaela

Yoak, Thomas Gray, Jzanese Weekes, Zac Atwell, Courtney Handley, Samantha Simmons,

Shannon Tolen, Darryl Baynes, Craig Arensberg.

Nutrition• 40 different nutrients.

• Stored fat is the most efficient source of energy

• Glucose is the second most efficient source of energy.

• Brain’s energy source is glucose

• http://www.mypyramid.gov/

ObesityObesity is being 20% heavier then your maximum recommend body weight.

2nd leading cause of death in America is obesity.

60 million people are affected by obesity.

DiabetesDiabetes

There are 2 types of There are 2 types of diabetes: Type 1 and diabetes: Type 1 and Type 2Type 2

Diabetes is caused Diabetes is caused by the pancreas not by the pancreas not producing insulin producing insulin properly or not properly or not enough natural enough natural insulin is being insulin is being produced.produced.

Diabetes can not be Diabetes can not be cured, but a healthy cured, but a healthy lifestyle can help lifestyle can help maintain diabetes.maintain diabetes.

In West Virginia In West Virginia 106,852 people 106,852 people (7.6%) have (7.6%) have diabetes. 53,000 diabetes. 53,000 have diabetes but have diabetes but are unaware.are unaware.

Benefits of exercise

• Reduces risk of disease, cancer, and premature death

• Reduces depression

• Improves well-being

• Enhances performance

Hypothesis (Question)Does a better understanding of risk factors for obesity and

diabetes lead to a change in behavior to avoid these risk factors?

This can be broken down into a structured framework using KWLH approach

What we KNOW (K) role of diet and exercise in energy \ metabolism obesity diabetes treatment of diabetes

What we WANT to find out (W) role in diet and exercise in energy metabolism obesity diabetes treatment of diabetes

What we LEARNED and want to tell others (L) Design and create an educational intervention

HOW do we know if this new information made any difference (H)

Design how the intervention will be implemented

Design a study to find out if the new information made a difference

a) Who to study? b) How many to study? c) What measurements to make in the study?

Analysis of results from study a) How can the results be best presented to the

community? b) Could design be improved?

Does the study raise new questions that can be answered by another study?

Ethics, Morals, and HIPAA.

Ethics- Do no harm, respect for persons, justice, and beneficent.

Morals- To set standards and live by them.

HIPAA- Health Insurance Portability & Accountability Act

Survey On DiabetesOn Tuesday we broke up into two groups and

ask questions to our BioMed peers. These are some of the questions

• 1. Do you have diabetes?• 2. Do either one of your parents have diabetes?• 3. Do any of your siblings have diabetes?• 4. Does any other of your family members have diabetes?• 5. Do any of your peers have diabetes?• 6. Have you ever been tested for diabetes?• 7. Do you think your present eating habits will lead to diabetes?• 8. Do you exercise enough to prevent diabetes? • 9. Do you feel that you’re at a healthy weight? Y/N/U• 10. Do you know the symptoms of diabetes?• Count how many people are in the room• Count of males/females• Count yes/no

Family TreeThis is an example of how we did our family tree.

Consent Form

• We made our own consent form for our Clinical Trial. We learned that you have word things exactly right and make questions very clear.

Thank You PITT!!!

Thanks to the Team from PITT we have Our own Group 5 website where we can

discuss issues, upload documents & keep in touch as we work on our Clinical Trials/Symposium Projects.

Our own webcams we can use to communicate with our group members across the state and Pittsburgh

https://ccp-236.dept-med.pitt.edu/hstasummer/default.aspx

HSTA’s SSTA’s and MSTA’s =)Learning How To Develop An Implement. A Clinical Trial.

Prototype of Clinical and Translational Research

Study

Outcome

Outcome

StudyHistory

BaselineEvaluation

TimeNo Intervention

Intervention

Subject AccrualSubject Intensive Description

Ŧ family historyŦ personal historyŦ measures of nutrition, exercise, obesity, and risk of diabetes

Interval endpoint measurement of selected variables

Ŧ feasible measurements for study in community

*~Creating A Clinical Trial~* Study The Subject That Is Being Used Complete a Consent Form Take a baseline survey Apply An Intervention and a control Post Evaluation Analyze The Results Publish Results

We constructed our own consent

form CERTIFICATION of INFORMED CONSENT

I certify that I have explained the nature and purpose of this research study to the above-named individual(s), and I have discussed the

potential benefits and possible risks of study participation. Any questions the individual(s) have about this study have been answered, and we will always be available to address future questions as they arise.”

___________________________________________________________

Printed Name of Person Obtaining Consent Role in Research Study

_________________________________ ____________ Signature of Person Obtaining Consent Date

IF THE RESEARCH STUDY INVOLVES CHILDREN, PLEASE SEE CHAPTER 8.0, SECTION 8.2 #14 FOR THE APPROPRIATE

LANGUAGE/SIGNATURE SPACES.

We practiced taking a base line survey.

And created a new survey to be

used.

Intervention...

Coming Soon!!!

Post Evaluation…

Future Events!! Send Data and Travel to Pittsburgh to

Analyze the results Use results for symposium Results published in a medical

educational journal Present our clinical trial at the Spring

National Institute of Health/ SEPA meeting

Thanks To: Dr. Branch, Steve Groark, Louise DeRiso, Dr Shama Buch, University of

Pittsburgh, Dr. Chester, Dr. Dooley, Jenny Bardwell, And Last But Not Least…WVU!

Special Thanks to: Cathy Morton, Delores Fondale