CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 315 enrolled
Drug / intervention
Blood Test Group Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02747108
NCT02747108N/ACompleted

Improving Veteran Engagement in Diabetes Prevention (CDA 13-267)

VA Office of Research and Development·interventional·Posted Apr 21, 2016·Updated Jul 25, 2023

In Brief

A clinical study evaluating Blood Test Group Intervention and Brochure Group Intervention for Prediabetes. Completed, enrolled 315 participants across 1 site.

Detailed Summary

This study will evaluate the effects of screening for type 2 diabetes mellitus (T2DM) and brief counseling about screening test results on weight and key health behaviors among Veterans with risk factors for T2DM. Study participants will be randomly assigned to one of two study groups: (1) Blood Test Group or (2) Brochure Group. Participants in the Blood Test Group will complete a blood test called hemoglobin A1c (HbA1c) which measures average blood sugar levels. Participants will receive brief counseling about the results from their primary care provider or someone authorized to speak on their behalf. Participants randomly selected for the Brochure Group will review a handout from the VA National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations. All participants will be asked to complete a survey prior to study group assignment, immediately after a Primary Care appointment, 3 months after enrollment, and 12 months after enrollment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrediabetes
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 21, 2016
Enrollment StartDec 2, 2015
Primary CompletionDec 1, 2018
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.2 years ago

Interventions

Blood Test Group Interventionbehavioral

Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet to promote and maintain weight loss, and set a goal of achieving and sustaining a weight loss of at least 5% of body weight.

Brochure Group Interventionbehavioral

Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment.