Healthy Living Partnership to Prevent Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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). 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.

Official Title
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Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)

Conditions
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Prediabetes, Obesity

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle<br>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. | Behavioral: Group-Based Lifestyle Intervention (Phases 1 and 2)<br>* 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.<br>* Other names: Community Health Worker-Led Intervention;Behavioral: Self-Directed Maintenance (Phase 3)<br>* 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.<br>* Other names: SDM;Behavioral: Extended Group Maintenance (Phase 3)<br>* 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.<br>* Other names: EGM;|
| Other: Comparison<br>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. | Other: Individual Education Program (All Phases)<br>* 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.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose | Change in fasting glucose will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year. The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period. | Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Weight loss will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year. The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period. | Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization | 
| Waist Circumference | Waist circumference will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year. The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period. | Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization | 
| Dietary Intake | Usual dietary intake will be assessed using a food frequency questionnaire (FFQ) in web-format. This software will be administered during assessments at the GCRC by trained dieticians on the GCRC staff. In addition, diet will be monitored daily by intervention participants through completion of their diet and physical activity logs. | Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization | 
| Physical Activity | We will use the International Physical Activity Questionnaire to evaluate between group differences in physical activity, an internationally reliable and valid instrument for assessing physical activity. The IPAQ short form is a 7-item index that asks respondents the number of days per week and the amount of time per day spent in vigorous- and moderate-intensity activities and walking, during the seven days prior to the interview. | Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prediabetes, overweight, obesity, metabolic syndrome, community health worker