Heart Healthy Lenoir: Return of Results Study (HHL)

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 Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Behavioral: Return of genomic results on cardiovascular disease risk

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Kinston, North Carolina, United States, 28501
      • Heart Healthy Lenoir Field Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Return of genomic results on cardiovascular disease risk; Participants will receive genomic cardiovascular disease risk information.	Behavioral: Return of genomic results on cardiovascular disease risk; 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.
Active Comparator: 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.	Behavioral: Return of genomic results on cardiovascular disease risk; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psychological Adaptation	The Psychological Adaptation Scale (PAS) measures adaptation to health risk information via a 20-item questionnaire rated on a 5-point Likert scale (1=Not At All to 5=Very Much). This questionnaire measures adaptation in 4 domains: coping efficacy, self-esteem, social integration, and spiritual well-being. This scale was developed specifically for use in genomic studies to measure adaptation and aid understanding in the relationship between health outcomes and psychological well-being. Biesecker BB, Erby LH, Woolford S, Adcock JY, Cohen JS, Lamb A, et al. Development and validation of the Psychological Adaptation Scale (PAS): Use in six studies of adaptation to a health condition or risk. Patient Educ Couns 2013.	Baseline, 3 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Harlyn G Skinner, MS, University of North Carolina, Chapel Hill; Study Chair: Alice Ammerman, DrPH, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: July 31, 2014
• First Posted (Estimate): August 4, 2014

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 4, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Genomics; Return of results
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 14-1500; 1P50HL105184-01 (U.S. NIH Grant/Contract)