Heart Healthy Lenoir: Return of Results Study

Cardiovascular Disease Clinical Trial

— HHL  

Official title:

Heart Healthy Lenoir: Return of Results Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208180
• Other study ID #: 14-1500
• Secondary ID: 1P50HL105184-01
• Status: Completed
• Phase: N/A
• First received: July 30, 2014
• Last updated: June 4, 2016
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Heart Healthy Lenoir Field Office	Kinston	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No