Diabetes Prevention Translation: the Healthy Lifestyle Project

University of Pittsburgh

Status: Completed

Conditions: Diabetes; Cardiovascular Risk Factor

Treatments: Behavioral: Delayed Intervention; Behavioral: Current Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01050205

R18DK081323-04 (U.S. NIH Grant/Contract)

PRO10010131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 223 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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223 participants in 2 patient groups

Current Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Current Intervention

Delayed Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Delayed Intervention