VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot
|ClinicalTrials.gov Identifier: NCT01671735|
Recruitment Status : Withdrawn (Not considered a clinical trial because both treatment protocols have been approved as usual care)
First Posted : August 23, 2012
Last Update Posted : October 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Other: Survey||Not Applicable|
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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||August 2013|
Experimental: VA DPP
Pre-Diabetic Participants eligible for VA DPP receive a curriculum based life-style intervention program tailored off of the original DPP but in a group format
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.
No Intervention: VA DPP-eligible MOVE!
Pre-Diabetic participants who screen and are eligible for VA DPP but bc of class being filled - have been assigned to MOVE!
- weight loss [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671735
|United States, Michigan|
|VA Ann Arbor Healthcare System|
|Ann Arbor, Michigan, United States, 48113-0170|
|Principal Investigator:||Caroline R Richardson, MD||VA Ann Arbor Healthcare System|