Heart Healthy Lenoir: Return of Results Study

Study Overview
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Brief Summary
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The investigators are conducting a two group intervention to study to the effect of individualized heart disease genomic risk results on motivation towards diet and physical activity behaviors to reduce heart disease risk. The intervention includes provided participants with genomic and lifestyle risk estimates. Investigators will follow participants for 3 months to determine if motivation towards and engagement in diet and physical activity behaviors change.

Official Title
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Heart Healthy Lenoir: Return of Results Study

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Return of genomic results on cardiovascular disease risk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in Heart Healthy Lenoir Genomics African-American (self-identified) Wants to be contacted for future studies Exclusion Criteria: Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral intervention (e.g. weight loss or weight maintenance programs)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Return of genomic results on cardiovascular disease risk<br>Participants will receive genomic cardiovascular disease risk information. | Behavioral: Return of genomic results on cardiovascular disease risk<br>* Experimental group: Participants will receive genomic cardiovascular disease risk information. Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.<br>|
| Active Comparator: Return of lifestyle results on cardiovascular disease risk<br>Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study. | Behavioral: Return of genomic results on cardiovascular disease risk<br>* Experimental group: Participants will receive genomic cardiovascular disease risk information. Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motivation | The Prevention and Planning Behaviors Scale is a recently developed tool that provides a direct measure of degrees of influence on participants' motivation to change their health behavior in translational genomic studies. It has 23-items where participants rate themselves using a 5-point Likert scale (1=A Lot Less Motivated to 5=A Lot More Motivated). | Baseline, Post-interview, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Eating Habits | Eating habits will be assessed using a 10-item Block questionnaire designed to capture the frequency with which participants eat particular items from different food groups. Participants will rate themselves on a 6-point scale ranging from Less than 1 time per WEEK to 2+ a DAY. | Baseline, 3 months | 
| Change in Physical Activity | The 16-item RESIDE Neighborhood Physical Activity Questionnaire will be used to assess context-specific walking behavior through self-report. Participants are asked how often they walk, how long, to where, and similar questions about what other types of physical activity they might engage in. Giles-Corti B, Timperio A, Cutt H, Pikora TJ, Bull FC, Knuiman M, et al. Development of a reliable measure of walking within and outside the local neighborhood: RESIDE's Neighborhood Physical Activity Questionnaire. Preventive medicine 2006;42(6):455-459. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Return of results, Genomics