Skip to main content
OpenTrials
Completed

NCT Number: NCT02208180

Heart Healthy Lenoir: Return of Results Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Healthy Lenoir Field Office

Kinston, North Carolina, 28501, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Return of genomic results on cardiovascular disease risk

Behavioral

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.

Primary outcomes

  1. 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

  1. Change in Eating Habits

    Time frame: 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."

  2. Change in Physical Activity

    Time frame: 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.

Other outcomes

  1. Change in Psychological Adaptation

    Time frame: Baseline, 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: HHL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2014
Registry last updated
Jun 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.