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Healthy Living Partnership to Prevent Diabetes (HELPPD)
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), December 2008
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00631345
  Purpose

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
Prediabetes
Obesity
Behavioral: Group-Based Lifestyle Intervention
Other: Individual Education Program
Phase III

MedlinePlus related topics: Diabetes Obesity Weight Control
U.S. FDA Resources
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)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • change in fasting glucose [ Time Frame: 6, 12, 18, and 24 months from randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight Loss [ Time Frame: 6, 12, 18, and 24 months from randomization ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: 6, 12 and 24 months from randomization ] [ Designated as safety issue: No ]

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
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.
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.
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.).
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.

Detailed 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). 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631345

Contacts
Contact: Caroline S Blackwell, B.S. (336) 713-4061 cblackwe@wfubmc.edu
Contact: Kara A Foster, B.S. (336) 716-8747 karfoste@wfubmc.edu

Locations
United States, North Carolina
Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: David C Goff, Jr., MD, PhD Wake Forest University
  More Information

Study Website  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
prediabetes
overweight
obesity
metabolic syndrome
community health worker

Study placed in the following topic categories:
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

ClinicalTrials.gov processed this record on January 15, 2009