VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot
NCT ID: NCT01671735
Last Updated: 2012-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2012-09-30
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
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!
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Similarly, patients who are being treated with metformin will be excluded, to avoid confounding factors in the analysis
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Caroline R Richardson, MD
Role: PRINCIPAL_INVESTIGATOR
VA Ann Arbor Healthcare System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RRP 12-440
Identifier Type: -
Identifier Source: org_study_id