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NCT01884545 · ClinicalTrials.gov registry record · NA

Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
220
Enrollment target

NCT01884545: Completed NA study, sponsored by Duke University.

NCT01884545 is a NA study that has completed, run by Duke University. The registered enrollment target is 220 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01884545, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
220 participants
Enrollment target

Study Summary

The purpose of this study is to examine whether the use of genetic test information and/or health coaching in patient risk counseling for heart disease and diabetes affect health behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and Air Force retiree patients. Total of 400 subjects will be enrolled. They will be randomly(like flipping a coin)assigned to 4 groups: 1)Standard risk assessment (SRA)only; 2)SRA plus genetic risk information (SRA+G); 3)SRA plus health coaching (SRA+HC); or 4)SRA, genetic risk information, and health coaching (SRA+G+HC). Subjects randomized to the two genetic arms will have blood collected for testing of investigational coronary heart disease (CHD) and type 2 diabetes (T2D) risk markers. Participants in the two groups that include health coaching will be assigned to a trained certified health coach for a period of 6 months. The duration of the study is 12 months with 3 in person visits (baseline, 6 months and 12 months) and completion of surveys at 6 weeks and 3 month time points.

Primary Outcome

Dietary intake as measured by percent energy from fat, adjusted for baseline

Interventions

  • BEHAVIORAL Health coaching
  • GENETIC Genetic risk counseling
  • BEHAVIORAL Standard risk assessment

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2013-07
Est. Completion 2017-02-01
Phase NA
Duke University

1,725 total trials

What the finished NCT01884545 record still lists

NCT01884545 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 3 interventions - of which Health coaching is the first listed.

NCT01884545 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01884545 about?

NCT01884545 is a clinical study titled "Genetic Risk and Health Coaching for Type 2 Diabetes and Coronary Heart Disease". The purpose of this study is to examine whether the use of genetic test information and/or health coaching in patient risk counseling for heart disease and diabetes affect health behaviors and health outcomes in active-duty Air Force (ADAF), beneficiaries or dependents and Air Force retiree patients...

What is the current status of trial NCT01884545?

This trial is currently completed. It is a NA study. The enrollment target is 220 participants. The study started on 2013-07. Estimated completion is 2017-02-01.

What interventions are being tested in trial NCT01884545?

The interventions under investigation include: Health coaching (BEHAVIORAL), Genetic risk counseling (GENETIC), Standard risk assessment (BEHAVIORAL).

Who is sponsoring clinical trial NCT01884545?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01884545's enrollment target sits among peer trials

220 481st of 2000 higher than 1,516 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01884545, the US trial registry maintained by the National Library of Medicine. NCT01884545 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.