NCT02208180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

July 30, 2014

Last Update Submit

June 4, 2016

Conditions

Cardiovascular Disease

Keywords

Return of resultsGenomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in Eating Habits

    Baseline, 3 months

  • Change in Physical Activity

    Baseline, 3 months

Other Outcomes (1)

  • Change in Psychological Adaptation

    Baseline, 3 months

Study Arms (2)

Return of genomic results on cardiovascular disease risk

EXPERIMENTAL

Participants will receive genomic cardiovascular disease risk information.

Behavioral: Return of genomic results on cardiovascular disease risk

Return of lifestyle results on cardiovascular disease risk

ACTIVE COMPARATOR

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

Interventions

Return of genomic results on cardiovascular disease riskBEHAVIORAL

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.

Return of genomic results on cardiovascular disease riskReturn of lifestyle results on cardiovascular disease risk

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in Heart Healthy Lenoir Genomics
  • African-American (self-identified)
  • Wants to be contacted for future studies

You may not qualify if:

  • Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral intervention (e.g. weight loss or weight maintenance programs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Healthy Lenoir Field Office

Kinston, North Carolina, 28501, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Harlyn G Skinner, MS

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Alice Ammerman, DrPH, MPH

    University of North Carolina, Chapel Hill

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

July 30, 2014

First Posted

August 4, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

US(1)