The Healthy Lifestyle Project

Diabetes Clinical Trial

Official title:

Diabetes Prevention Translation Project: the Healthy Lifestyle Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01050205
• Other study ID #: PRO10010131
• Secondary ID: R18DK081323-04
• Status: Completed
• Phase: N/A
• First received: January 13, 2010
• Last updated: May 27, 2015
• Start date: September 2010
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Baseline and post-intervention (assessed at 6 months after commencement of intervention)	No
Secondary	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.		Baseline and post-intervention (assessed at 6 months after commencement of intervention)	No