Heart Healthy Lenoir: Return of Results Study

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Return of genomic results on cardiovascular disease risk

• Registration Number: NCT02208180
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-30
• Study First Submitted QC: 2014-07-31
• Study First Posted: 2014-08-04
• Study Start: 2014-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-04
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Return of lifestyle results on cardiovascular disease risk	Return of genomic 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.
Return of genomic results on cardiovascular disease risk	Return of genomic results on cardiovascular disease risk	Participants will receive genomic cardiovascular disease risk information.

Primary Outcome Measures

Name	Time	Method
Change in motivation	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 Outcome Measures

Name	Time	Method
Change in Physical Activity	Baseline, 3 months	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.
Change in Eating Habits	Baseline, 3 months	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."

Trial Locations

Locations (1)

Heart Healthy Lenoir Field Office; 🇺🇸 Kinston, North Carolina, United States