Healthy Living Partnership to Prevent Diabetes

NACompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
PrediabetesObesity
Interventions
BEHAVIORAL

Group-Based Lifestyle Intervention (Phases 1 and 2)

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 the first 6-months of treatment (Phase 1) for a total weight loss of 5-7%. During Phase 2 (months 7-24) participants will be encouraged to continue weight loss as long as their BMI does not fall below 20 kg/m2, but the primary focus will be on weight maintenance. 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.

OTHER

Individual Education Program (All Phases)

Comparison participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the RD 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 and will receive the lifestyle intervention manual and video series at the conclusion of their participation. These participants will be approached about the continuation at 24 months. If they agree to participate, these participants will continue to receive a monthly newsletter and will also receive biannual RD contacts.

BEHAVIORAL

Self-Directed Maintenance (Phase 3)

Individuals from the lifestyle intervention group in the original HELP PD project who are randomized to self-directed maintenance will receive biannual nutrition counseling from the study RDs. In these sessions, the RD will cover basic aspects of transition from the group maintenance to individual maintenance, answer questions about healthy eating and activity to support weight loss, and discuss existing community resources that may fit the participants' needs as they attempt to maintain their weight loss, physical activity and dietary goals.

BEHAVIORAL

Extended Group Maintenance (Phase 3)

The extended group maintenance condition will consist of monthly CHW-led group meetings, monthly individual telephone contacts with the CHW, biannual RD contacts, and other contacts as needed. During Phase 3, the objectives for Phase 2 of the initial program will be continued. That is, participants who were successful at weight loss (≥ 7% of initial body weight) are encouraged to either maintain their weight loss or to advance towards their own personal goals. Participants who were not successful are encouraged to problem solve the reasons for lack of success. The groups will focus on maintaining the healthy behaviors that produced weight loss and/or problem solving to overcome barriers to weight loss.

Trial Locations (1)

27157

Wake Forest University School of Medicine, Winston-Salem

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT00631345 - Healthy Living Partnership to Prevent Diabetes | Biotech Hunter | Biotech Hunter