Healthy Living Partnerships to Prevent Diabetes (HELP PD): Design and methods

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Abstract

Although the Diabetes Prevention Program (DPP) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals, it has yet to be widely adopted at the community level. The Healthy Living Partnership to Prevent Diabetes study (HELP PD) was designed to translate the DPP approach for use in community settings as a cost-effective intervention led by Community Health Workers (CHW's) and administered through a Diabetes Care Center (DCC). Approximately 300 overweight and obese (BMI 25-40 kg/m2) individuals with prediabetes (fasting blood glucose 95-124 mg/dl) were randomly assigned to either a lifestyle weight loss intervention (LW) or an enhanced usual care comparison condition (UC). The goal of LW is ≥ 7% weight loss achieved through increases in physical activity (180 min/wk) and decreases in caloric intake (approximately 1500 kcal/day). The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months. UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter. The primary outcome is change in fasting blood glucose. Secondary outcomes include cardiovascular risk factors, health-related quality of life, and social cognitive variables. Outcomes are masked and are collected every 6 months. The cost-effectiveness of the program will also be assessed. A community-based program that is administered through local DCC's and that harnesses the experience of community members (CHW's) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals.

Introduction

The prevalence of Type II diabetes continues to increase in both older and younger adults [1], [2], [3]. Although evidence suggests that diabetes mortality has declined in the last ten years by 8.3%, diabetes-related complications continue to increase resulting in rising disease burden [4]. These realities exist despite the success of large scale clinical trials, such as the Diabetes Prevention Program (DPP) and the Finish Diabetes Prevention Study (DPS), demonstrating that weight loss resulting from changes in diet and physical activity can decrease the incidence of diabetes [5], [6].

It has been argued that the lack of large-scale implementation of effective diabetes prevention programs is due to a general lack of understanding of translational research [7], [8]. That is, although compelling evidence exists demonstrating the efficacy of lifestyle interventions in clinical settings [9], whether these strategies can be successfully implemented in the community is an unanswered question. Although recent projects have attempted to translate the DPP intervention, sample sizes have been small and the degree of translatability is unknown [10], [11], [12], [13], [14]. The overall goal of the Healthy Living Partnerships to Prevent Diabetes (HELP PD) project is to translate the methods of the DPP into the community setting by incorporating several key translations of prior research to enhance logistical and fiscal feasibility and long term dissemination: the use of a group-based intensive lifestyle behavioral intervention employing professional and community health workers (CHWs) and delivery of the intervention in the community setting via innovative expansion of an existing Diabetes Education Program (DEP) in collaboration with CHWs as empowered community partners.

Section snippets

Primary Research Goals

The primary hypothesis being tested in HELP PD is that a lifestyle intervention (addressing healthy eating, physical activity, and weight loss) administered through a community-based diabetes prevention program model will have a beneficial and clinically meaningful impact on glucose and insulin metabolism, and markers of the metabolic syndrome. It compares, in overweight and obese volunteers with elevated fasting glucose, the effects of two study conditions: a lifestyle intervention designed to

Overview

A total of 300 participants with pre diabetes (fasting blood glucose = 95 mg/dl  FBG  125) were recruited over 2 years and randomized to either a CHW led lifestyle intervention or an enhanced usual care intervention. Our comparison intervention condition is an individual education program that builds on an increased awareness of existing community resources and is designed to exceed the usual care provided to similar community members and to enhance retention. Comparison participants receive two

Study Management

The Help PD Trial is conducted by a unique and multi-disciplinary team, including trialists, epidemiologists, internists, nutritionists, exercise physiologists, behavioral scientists, biostatisticians and economists to develop the protocol and interventional components of this study. A companion Manual of Operations and Intervention Manual provides specific operational details of the project for all study personnel. The study is managed through several committees with distinct roles and

Discussion

Although diabetes-related mortality has declined in recent years, the continued rise in prevalence and incidence has resulted in increases in the overall public health burden and highlights the need for effective diabetes prevention interventions [4], [7], [8], [43]. While the DPP provided compelling evidence that weight loss achieved through lifestyle behavioral interventions can decrease the risk of diabetes incidence in individuals at high risk for diabetes, additional research is needed to

Acknowledgment

This study was funded by grant #R18 DK69901-01A2.

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