At a glance
ClinicalIndex Comparison Record- ✓BMI between 25 and 40 kg/m²
- ✓Evidence of pre-diabetes confirmed by one of: HbA1c 5.7-6.4%, fasting plasma glucose 95-125 mg/dL, or oral glucose tolerance test 140-200 mg/dL, measured within the past 3 months
- ✓Willing to accept randomization to either the lifestyle intervention or enhanced usual care condition
- ✕Currently enrolled in a supervised weight loss program
- ✕Clinical history of diabetes
- ✕Cardiovascular disease (myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, or congestive heart failure) occurring within the past 6 months
- ✕Uncontrolled high blood pressure (systolic >160 or diastolic >100 mmHg); participants may be rescreened once controlled
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
In Brief
A clinical study evaluating HELP Vets Intervention and Individual Education Program for Pre-diabetes and Obesity. Completed, enrolled 118 participants across 2 sites.
Detailed Summary
Diabetes and obesity are both major public health concerns and the prevalence of diabetes is even higher in the patient population of the Veterans Administration. This planning project is designed to adapt a successful weight-loss program for delivery through an existing outpatient clinic to reach local Veterans at risk for developing diabetes. The information gathered as a part of this project will be used to plan a larger trial designed to improve the health of Veterans by offering them a diabetes prevention program through their usual source of healthcare.
Study Details
Timeline
Interventions
This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.