The Healthy Lifestyle Project

This study is currently recruiting participants.
Verified January 2011 by University of Pittsburgh
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01050205
First received: January 13, 2010
Last updated: January 13, 2011
Last verified: January 2011
  Purpose

The Diabetes Prevention Program (DPP), a large research study conducted in the United States, found that lifestyle intervention was effective in lowering risk for development of type 2 diabetes. It is important to evaluate the DPP lifestyle interventions in "real world" settings. The purpose of this project is to test an adapted version of the DPP lifestyle intervention in several community settings, including a worksite, a health care facility (primary care practice and local community centers dedicated to older adults.


Condition Intervention
Diabetes
Cardiovascular Risk
Behavioral: Group Lifestyle Balance Group or DVD
Behavioral: Delayed Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diabetes Prevention Translation Project: the Healthy Lifestyle Project

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Significant changes in weight in the intervention between baseline and post-intervention (assessed at 6 months after commencement of intervention) compared to delayed intervention participants. [ Time Frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in fasting glucose, insulin, BP, waist circumference, lipids,physical activity and quality of life between baseline and post-intervention (assessed at 6 months after commencement of intervention) compared to delayed intervention participants. [ Time Frame: Baseline and post-intervention (assessed at 6 months after commencement of intervention) ] [ Designated as safety issue: No ]

Estimated Enrollment: 351
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Current Intervention
Eligible participants will be asked to choose Group Lifestyle Balance Group (GLB-Group) or Group Lifestyle Balance DVD (GLB-DVD). Upon choosing, participants will be randomly assigned to "Current intervention" Arm in which case they will receive the intervention immediately.
Behavioral: Group Lifestyle Balance Group or DVD

Participants assigned to Current Intervention will receive the intervention described below immediately after randomization.

GLB-GROUP: Members of the original DPP lifestyle team collaborated to adapt the individual intervention to a group-based program and to condense the program from 16 individual sessions delivered over 24 weeks to 12 group sessions delivered over 12-14 weeks. As in the original DPP lifestyle program, the goals of the GLBintervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity similar to a brisk walk.

GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. GLB-DVD covers all of the sessions of the Group Lifestyle Balance program; sessions are portrayed by professional actors.

Active Comparator: Delayed Intervention
Eligible participants will be asked to choose Group Lifestyle Balance Group (GLB-Group) or Group Lifestyle Balance DVD (GLB-DVD). Upon choosing, participants will be randomly assigned to "Delayed Intervention" Arm in which case they will receive delayed intervention at 6 months.
Behavioral: Delayed Intervention

Participants assigned to Delayed Intervention will receive the same intervention as Current Intervention Group, 12 months after randomization.

GLB-GROUP: Members of the original DPP lifestyle team collaborated to adapt the individual intervention to a group-based program and to condense the program from 16 individual sessions delivered over 24 weeks to 12 group sessions delivered over 12-14 weeks. As in the original DPP lifestyle program, the goals of the GLBintervention are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes per week of moderately intense physical activity similar to a brisk walk.

GLB-DVD: Consists of a series of taped sessions of a staged GLB group following a script which was developed to closely follow the original Group Lifestyle Balance. GLB-DVD covers all of the sessions of the Group Lifestyle Balance program; sessions are portrayed by professional actors.


Detailed Description:

Evidence that lifestyle intervention can prevent or delay the development of type 2 diabetes has been demonstrated in several clinical trials including a multi center clinical trial in the US, the Diabetes Prevention Program (DPP). The challenge for public health is to translate this promising and proven behavioral intervention utilized in the DPP research effort to the "real world", i.e., how to make it work in diverse communities in a variety of local settings at a reduced cost so that the maximal number of those at risk can benefit.

The purpose of this application is to test a framework for translation of the DPP that includes: 1) demonstration of a training model for community health care professionals that includes initial training, support, and supervision in the delivery of a diabetes prevention curriculum and the needed behavioral lifestyle materials both initially and over time; 2) evaluation of a more compact and flexible DPP intervention program administered to each participant in a version of his or her choice (standard face-to-face group format or a DVD version of the same lifestyle intervention program content). These lifestyle intervention programs will be carried out in three different community settings; i.e. a health care practice, a worksite, and local centers in the community dedicated to healthy aging for older adults. Lastly, the cost-effectiveness analyses of the GLB intervention program in each of the three community settings will be tested.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Screening Eligibility Criteria: Non-diabetic men and women from the specific study sites in the local area who are age 18 years and older at the time of screening with a BMI of at least 25 kg/m2 are eligible for screening.
  • Intervention Eligibility Criteria: Individuals attending screening who are found to have prediabetes AND/OR metabolic syndrome are eligible to participate in the intervention. Pre-diabetes is defined as having a fasting glucose >100 mg/dL and <126mg/dL. Metabolic syndrome is defined as having at least 3 of the 5 following risk factors:

    1. Waist circumference (>40 inches men, >35 inches women);
    2. Blood pressure >130 mmHg (systolic) or >85 mmHg (diastolic) OR history of diagnosed hypertension
    3. Low HDL level (<40mg/dL men, <50 mg/dL women)
    4. Elevated triglyceride level >150 mg/dL
    5. Fasting glucose >100mg/dL and <126mg/dL All individuals enrolled in the study should have at least 6th grade reading/writing ability.

Exclusion Criteria:

  • Screening Exclusionary Criteria: Women who are currently (or within past 6-weeks) pregnant or lactating, or any individual planning to leave the area before the end of the effort will be considered ineligible to participate in the screening.
  • Intervention Exclusionary Criteria: Exclusionary criterion for intervention is the same as for screening. In addition, individuals who are on metformin or are identified as having diabetes as a result of the screening are not eligible. Individuals who have recently (within the past 3 months) initiated or changed their dosage of any blood pressure or lipid medication will also be excluded as being on an unstable regimen will complicate the interpretation of any blood pressure or lipid effects of the intervention.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050205

Contacts
Contact: M. Kaye Kramer, DrPH 412-383-1680 mkk3@pitt.edu
Contact: Katie Benchoff 412-383-1286 benchoffc@edc.pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Katie Benchoff    412-383-1286    dpsc@edc.pitt.edu   
Principal Investigator: Andrea M Kriska, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Andrea M Kriska, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Dr. Andrea Kriska, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01050205     History of Changes
Other Study ID Numbers: PRO10010131
Study First Received: January 13, 2010
Last Updated: January 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Diabetes Prevention
Cardiovascular Risk Reduction
Lifestyle Intervention
Group Lifestyle Balance
Diabetes Prevention and Cardiovascular Risk Reduction via Lifestyle Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014