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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00631345 |
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.
Condition | Intervention | Phase |
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Prediabetes Obesity |
Behavioral: Group-Based Lifestyle Intervention Other: Individual Education Program |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM) |
Estimated Enrollment: | 300 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Lifestyle: Experimental
This is an intensive intervention aimed at promoting healthy eating, increasing physical activity and 5-7% weight loss. The sessions will be facilitated by lay health counselors (LHC) and content will be delivered by an educational DVD series. The intervention has 2 phases, a 6-month intensive phase followed by an 18-month maintenance phase. The intensive phase will involve weekly meetings covering nutrition and physical activity-related content, psychosocial factors related to health behaviors and troubleshooting/question and answer periods. Each participant will also receive individual counseling sessions with a registered dietician during months 1, 3, and 6. The maintenance phase will consist of monthly LHC-led group meetings and individual telephone contacts with the LHC.
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Behavioral: Group-Based Lifestyle 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 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.
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Comparison
The comparison arm will consist of two individual sessions with the RD outlining healthy diet and physical activity and providing information on community resources (e.g., parks, walking trails, fitness facilities, weight loss programs, etc.).
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Other: Individual Education Program
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. 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, and discuss existing community resources that may fit the individual needs of comparison participants as they pursue dietary change, increased physical activity and weight loss. Comparison participants will receive a monthly newsletter with topics related to healthy lifestyle and will receive the lifestyle intervention manual and video series at the conclusion of their participation.
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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). Unchecked, the human toll of these conditions will be staggering over the coming decades, especially in ethnic groups that are disproportionately affected, thereby contributing to health disparities. 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. This project will address this critical gap in knowledge. The overall goal will be to create a Healthy Living Partnership to Prevent Diabetes (HELP Prevent Diabetes) in the community setting. This project will incorporate several key translations of prior research to enhance logistical and fiscal feasibility and long term dissemination: 1) case finding of persons at risk of diabetes based on adiposity and fasting glucose, rather than results from an oral glucose tolerance test, 2) the use of a group-based, rather than an individual-based, intensive lifestyle behavioral intervention employing professional and lay health counselors (LHCs), and 3) delivery of the intervention in the community setting via innovative expansion of an existing Diabetes Education Program (DEP) in collaboration with LHCs as empowered community partners. DEPs are logical potential homes for the expertise needed to establish community-based diabetes prevention programs, as DEPs have demonstrated effectiveness for improving the quality of care for patients with type 2 DM, are available in many communities, and have personnel with expertise in lifestyle interventions regarding physical activity and diet. If the planned approach is successful, health care policies could be implemented to provide for the reimbursement of community-based diabetes prevention program services, as is currently the case for DEP services. A program delivered through a collaborative effort between DEPs, LHCs, primary care sites providing care to the underserved, and local public health agencies may be the most promising strategy for reaching out to underserved and minority populations at risk for developing type 2 DM.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Caroline S Blackwell, B.S. | (336) 713-4061 | cblackwe@wfubmc.edu |
Contact: Kara A Foster, B.S. | (336) 716-8747 | karfoste@wfubmc.edu |
United States, North Carolina | |
Wake Forest University School of Medicine | Recruiting |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | David C Goff, Jr., MD, PhD | Wake Forest University |
Responsible Party: | Wake Forest University School of Medicine ( David C. Goff, Jr. MD, PhD ) |
Study ID Numbers: | DK69901 - HELP, 1 R18 DK69901-01A2 |
Study First Received: | March 5, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00631345 |
Health Authority: | United States: Federal Government; United States: Institutional Review Board |
prediabetes overweight obesity metabolic syndrome community health worker |
Obesity Metabolic Diseases Glucose Intolerance Diabetes Mellitus Prediabetic State Endocrine System Diseases Overweight Healthy |
Body Weight Signs and Symptoms Hyperglycemia Nutrition Disorders Overnutrition Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |