NCT02835495

Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

The Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed description

Type II diabetes and its complications disproportionately affect the patient population served by the Department of Veterans Affairs (VA). Recent lifestyle interventions have demonstrated that weight-loss achieved through reductions in calorie intake and increases in physical activity can prevent or delay the onset of diabetes. The Healthy Living Partnerships to Prevent Diabetes (HELP PD), a community-based adaptation of the lifestyle intervention used in the Diabetes Prevention Program, achieved more than a 7% weight loss at 6 months. In HELP Vets, researchers will test the feasibility of further translating the HELP PD lifestyle intervention, tailored for use in the Veteran population, in the Kernersville Community-Based Outpatient Clinic operated by the VA. The investigators plan to recruit 50 overweight or obese Veterans at high risk for developing diabetes from the existing patient population to participate in a 6-month weight loss intervention led by community health workers who are also Veterans. As VA outpatient clinics have the requisite infrastructure to identify, screen, and enroll participants and access to Veteran community health workers from within their patient populations, they are ideal potential homes for diabetes prevention programming. Data gathered during this planning grant will be used to develop a large-scale study to test implementing the HELP Vets intervention in a larger segment of the Veteran population.

Conditions

• Pre-diabetes
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	HELP Vets Intervention	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.
BEHAVIORAL	Individual Education Program	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.

Timeline

• Start date: 2017-11-15
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2016-07-18
• Last updated: 2020-09-24
• Results posted: 2020-09-24

Locations

2 sites across 1 country: United States