Healthy Living Partnership to Prevent Diabetes (HELPPD)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00631345
First received: March 5, 2008
Last updated: May 25, 2011
Last verified: May 2011
  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 (Phases 1 and 2)
Other: Individual Education Program (All Phases)
Behavioral: Self-Directed Maintenance (Phase 3)
Behavioral: Extended Group Maintenance (Phase 3)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Fasting Glucose [ Time Frame: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Weight Loss [ Time Frame: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization ] [ Designated as safety issue: No ]
    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.

  • Waist Circumference [ Time Frame: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization ] [ Designated as safety issue: No ]
    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.

  • Dietary Intake [ Time Frame: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization ] [ Designated as safety issue: No ]
    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.

  • Physical Activity [ Time Frame: Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization ] [ Designated as safety issue: No ]
    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.


Enrollment: 301
Study Start Date: August 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle
Weight-loss group sessions will be facilitated by lay health counselors (LHC) and content will be delivered by a DVD series. The 6-month intensive phase (Phase 1) will involve weekly meetings covering nutrition and physical activity-related content, psychosocial factors related to health behaviors and troubleshooting/question and answer periods. Subjects will receive individual sessions with nutritionist during months 1, 3, and 6. The 18-month maintenance phase (Phase 2) will consist of monthly LHC-led group meetings and individual telephone contacts with the LHC. Intervention participants who choose to participate in the study continuation (Phase 3) will be further randomized to receive either extended group maintenance or self-directed maintenance.
Behavioral: Group-Based Lifestyle Intervention (Phases 1 and 2)
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.
Other Name: Community Health Worker-Led Intervention
Behavioral: Self-Directed Maintenance (Phase 3)
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.
Other Name: SDM
Behavioral: Extended Group Maintenance (Phase 3)
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.
Other Name: EGM
Comparison
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)
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.
Other Name: Control

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). 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.

  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

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David C. Goff, Jr. MD, PhD, Wake Forest University School of Medicine
ClinicalTrials.gov Identifier: NCT00631345     History of Changes
Other Study ID Numbers: R18DK69901, R18DK069901, 1R18DK069901-01A2
Study First Received: March 5, 2008
Last Updated: May 25, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
prediabetes
overweight
obesity
metabolic syndrome
community health worker

Additional relevant MeSH terms:
Obesity
Glucose Intolerance
Prediabetic State
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014