Heart Healthy Lenoir: Return of Results Study (HHL)

University of North Carolina (UNC)

Status: Completed

Conditions: Cardiovascular Disease

Treatments: Behavioral: Return of genomic results on cardiovascular disease risk

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02208180

14-1500

1P50HL105184-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

Return of genomic results on cardiovascular disease risk

Experimental group

Description:

Participants will receive genomic cardiovascular disease risk information.

Treatment:

Behavioral: Return of genomic results on cardiovascular disease risk

Return of lifestyle results on cardiovascular disease risk

Active Comparator group

Description:

Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.

Treatment:

Behavioral: Return of genomic results on cardiovascular disease risk