Heart Healthy Lenoir: Return of Results Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Change in motivation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Return of genomic results on cardiovascular disease risk
Participants will receive genomic cardiovascular disease risk information.
Intervention: Return of genomic results on cardiovascular disease risk (Behavioral)
Return of lifestyle results on cardiovascular disease risk
Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.
Intervention: Return of genomic results on cardiovascular disease risk (Behavioral)
Outcomes
Primary Outcomes
Change in motivation
Time Frame: Baseline, Post-interview, 3 months
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).
Secondary Outcomes
- Change in Physical Activity(Baseline, 3 months)
- Change in Eating Habits(Baseline, 3 months)
Investigators
Harlyn Skinner, MS
Doctoral Candidate
University of North Carolina, Chapel Hill