VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot

Diabetes Clinical Trial

Official title:

VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01671735
• Other study ID #: RRP 12-440
• Status: Withdrawn
• Phase: N/A
• First received: August 20, 2012
• Last updated: October 12, 2012
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: October 2012
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will collect baseline survey data from a NCP funded VA Diabetes Prevention Program (VA DPP) clinical demonstration program at three medical centers on VA DPP participants and VA DPP-eligible VA MOVE! participants to identify baseline participant demographic characteristics; attitudes and beliefs about diet, exercise and weight loss, and psychosocial constructs such as social support; and self-regulation skills that predict 6-month weight loss and program attendance. The data collected will contribute to our knowledge of pre-diabetic Veterans' attitudes and beliefs about diet, exercise and weight loss, to our understanding of how different programs may impact weight loss, and to evidence-based targeting in future clinical implementation projects. It will also provide baseline quality of life data for use in a future cost-effectiveness analysis.

Description:

Background:

Type 2 diabetes is a preventable disease. Multiple large scale randomized controlled trials have shown that in people with impaired glucose tolerance, Type 2 diabetes can be prevented with prevention lifestyle interventions that emphasize diet, exercise and weight loss. The Diabetes Prevention Program (DPP) showed that lifestyle interventions can reduce the incidence of type 2 diabetes by 58% in this high risk group. Little is known about the incidence of pre-diabetes in the VA because routine screening for pre-diabetes is not an established practice in the VA. With a few exceptions, lifestyle modification interventions that target individuals with pre-diabetes and follow the Diabetes Prevention Program curriculum are not available to Veterans in the VA. In order to address this gap in evidence based clinical services, the National Center for Health Promotion and Disease Prevention (NCP) has funded a VA Diabetes Prevention Program Demonstration Project (VA DPP) at 3 VA Medical Centers (Baltimore, Minneapolis, and Greater Los Angeles). NCP has requested assistance to conduct a more extensive implementation focused evaluation of VA DPP.

Methods Baseline survey data will be collected from 720 Veterans eligible for the VA DPP (360 in the VA DPP group, 360 in VA MOVE!) from 3 Medical Centers across the country. All participants referred to the VA MOVE! program will be evaluated for VA DPP eligibility and scheduled for a VA MOVE! orientation meeting. At that face-to-face orientation meeting, VA DPP-eligible Veterans will be invited to complete the baseline survey after completing an informed consent process and signing a written informed consent document. Consented Veterans will be provided with a paper copy of the survey, a stamped return envelope addressed to the Ann Arbor VA coordinating center and an incentive gift card or voucher. Instructions on the survey will include a URL link to an online survey that can be used by Veterans who prefer to answer the survey online as opposed to taking the paper survey. The survey will include a unique participant code that will be used to match survey data with clinical and administrative data by participant. The participant code will also be used to access the online survey. There will be no other personal identifiers on the survey.

Objectives

1. To identify baseline participant demographic characteristics: attitudes and beliefs about diet, exercise and weight loss: psychosocial constructs such as social support; and self-regulation skills that predict 6-month weight loss and program attendance.

2. To collect baseline survey data on hypothesized modifiable mediators of program impact on weight loss including outcome expectations, self-regulation, skill mastery, willingness to self-monitor, self-efficacy for use in subsequent analyses after 6- and 12-month survey data and to collect quality of life data to be used in future cost-effectiveness studies.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Overweight or obese Veterans who qualify for VA MOVE! who also have pre-diabetes by the CDC

• NDPRP criteria (fasting glucose of 100 to 125 mg/dl or Hgb A1C of 5.7 to 6.4 )

• and who live within one hour of one of three VAMCs (Baltimore, Minneapolis and Greater Los Angeles) will be eligible for the VA DPP program

• Veterans who have been assigned to the VA DPP program or Veterans who have been screened for the VA DPP program are eligible but classes have been filled and have been assigned to VA MOVE! will be asked to consent to complete a survey questionnaire at the time of enrollment

• They will also be asked to consent for access to link their program data (such as weight, BMI, visit attendance) to their survey data

Exclusion Criteria:

• Patients with A1C of 6.5-6.9% although considered pre-diabetic by VA criteria, will be excluded, as they are considered diabetic based upon ADA and NDPRP criteria for the VA DPP clinical program

• Similarly, patients who are being treated with metformin will be excluded, to avoid confounding factors in the analysis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Survey
A clinical demonstration project funded by NCP will involve screening Veterans and enrolling veterans with pre-diabetes into the VA DPP program. This research project will recruit VA DPP eligible participants enrolled in the VA DPP program and Veterans enrolled in MOVE! that are VA DPP eligible as a comparison group. The research is not truly an intervention but similar to a program evaluation.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss		one year	No