Heart Healthy Lenoir: Return of Results Study

NCT ID: NCT02208180

Last Updated: 2016-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Return of genomic results on cardiovascular disease risk

Participants will receive genomic cardiovascular disease risk information.

Group Type EXPERIMENTAL

Return of genomic results on cardiovascular disease risk

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Return of genomic results on cardiovascular disease risk

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Harlyn Skinner, MS

Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harlyn G Skinner, MS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Alice Ammerman, DrPH, MPH

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

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Heart Healthy Lenoir Field Office

Kinston, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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1P50HL105184-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1500

Identifier Type: -

Identifier Source: org_study_id

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