Study Stopped
Not considered a clinical trial because both treatment protocols have been approved as usual care
VA Diabetes Prevention: Epidemiology of Pre-Diabetes and Implementation Pilot
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2012
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2012
CompletedFirst Posted
Study publicly available on registry
August 23, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedOctober 15, 2012
October 1, 2012
10 months
August 20, 2012
October 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
weight loss
one year
Study Arms (2)
VA DPP
EXPERIMENTALPre-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
VA DPP-eligible MOVE!
NO INTERVENTIONPre-Diabetic participants who screen and are eligible for VA DPP but bc of class being filled - have been assigned to MOVE!
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113-0170, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline R Richardson, MD
VA Ann Arbor Healthcare System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2012
First Posted
August 23, 2012
Study Start
September 1, 2012
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
October 15, 2012
Record last verified: 2012-10