Cardiovascular Disease
Conditions
Keywords
Return of results, Genomics
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.
Interventions
BEHAVIORALReturn 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Psychological Adaptation | 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. |
Countries
United States
Outcome results
None listed