Healthy Living Partnership to Prevent Diabetes (HELP PD)

Wake Forest University (WFU)

Status: Completed

Conditions: Prediabetes; Obesity

Treatments: Behavioral: Self-Directed Maintenance (Phase 3); Other: Individual Education Program (All Phases); Behavioral: Group-Based Lifestyle Intervention (Phases 1 and 2); Behavioral: Extended Group Maintenance (Phase 3)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00631345

IRB00000613

R18DK069901 (U.S. NIH Grant/Contract)

1R18DK069901-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.

Full description

Social forces have promoted adverse behavioral patterns with respect to physical activity and nutrition resulting in the current epidemics of obesity, the metabolic syndrome and type 2 diabetes mellitus (DM). Results from clinical trials such as the Diabetes Prevention Program (DPP) have demonstrated a significant potential for prevention of type 2 DM through lifestyle interventions to promote physical activity, a healthy eating pattern and weight loss. Yet these approaches are not being applied in practice. In fact, whether these approaches can be successfully implemented in the community is an unanswered question. The Healthy Living Partnership to Prevent Diabetes (HELP PD) was designed to address this knowledge gap in a community setting. It incorporates key translations of prior research to enhance logistical and fiscal feasibility and long term dissemination, including the use of a group-based, rather than an individual-based, intensive lifestyle behavioral intervention employing professionals and community health workers (CHWs), and delivery of the intervention in the community setting via expansion of an existing Diabetes Education Program (DEP). The trial has been continued for an additional 5 years, and the primary goal of the continuation is to test the long-term glucose lowering effects of the HELP PD intervention by randomizing the lifestyle group to continued group maintenance or a self-directed maintenance condition and to follow the UC group for additional comparison purposes. Demonstrating the longer term effectiveness of HELP PD will represent a key step in establishing the value of this approach to translation of DM prevention into the community. This crucial evidence will be used to support reimbursement policy for DM prevention, dissemination of the HELP PD CHW approach and generalization to other behaviorally influenced chronic diseases.

Enrollment: 301 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials
• BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2
• Fasting blood glucose 95-125 mg/dl (inclusive)
• Willingness to Accept Randomization

Exclusion criteria

• Currently involved in a supervised program for weight loss
• Clinical history of DM, or newly diagnosed DM at screening
• Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure
• Uncontrolled high blood pressure: BP > 160/100
• Pregnancy, breast feeding, or planning pregnancy within 2 years
• Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
• Chronic use of medicine known to significantly affect glucose metabolism, e.g., corticosteroids
• Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP PD, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), and participation in another research study that would interfere with HELP PD

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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301 participants in 2 patient groups

Lifestyle

Experimental group

Description:

This Group-Based Lifestyle Intervention (Phases 1 and 2) will be led by lay health counselors (LHCs). The 6-month Phase 1 includes weekly meetings on nutrition and physical activity, psychosocial factors related to health behaviors, and question and answer periods. The 18-month Phase 2 will consist of monthly group meetings and individual telephone contacts. Intervention participants who choose to participate in the study continuation (Phase 3) will be further randomized to receive either extended group or self-directed maintenance. Those who are randomized to receive Extended Group Maintenance (Phase 3) will continue attending monthly meetings; those who receive Self-Directed Maintenance (Phase 3) will no longer attend groups.

Treatment:

Behavioral: Extended Group Maintenance (Phase 3)

Behavioral: Group-Based Lifestyle Intervention (Phases 1 and 2)

Behavioral: Self-Directed Maintenance (Phase 3)

Comparison

Other group

Description:

The comparison condition exceeds the usual care provided to similar community members and is an individual education program that builds on an increased awareness of existing community resources. In the initial trial, these subjects will receive two individual sessions with the RD and a monthly newsletter. In the study continuation, comparison participants will receive biannual nutrition counseling and a monthly newsletter.

Treatment:

Other: Individual Education Program (All Phases)