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NCT02162901 · ClinicalTrials.gov registry record · NA
The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs
A NA study, sponsored by Virginia Polytechnic Institute and State University.
- Completed
- Registry status
- NA
- Development phase
- 597
- Enrollment target
NCT02162901 is a NA study that has completed, run by Virginia Polytechnic Institute and State University. The registered enrollment target is 597 participants.
The verdict
NCT02162901, a NA study, has completed, sponsored by Virginia Polytechnic Institute and State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 597 participants
- Enrollment target
Study Summary
The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a health care setting. The overall aim is consistent with the NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. While evidence of lifestyle interventions that increase physical activity and improve eating habits to achieve modest weight loss in delaying and preventing the onset of type 2 diabetes continues to mount, the translation of these interventions into effective programs to health care settings with modest resources remains a challenge. The proposed research project will conduct a pragmatic clinical trial that employs a hybrid Preference/Randomized Controlled Trial (RCT) designed to compare two technology-enhanced diabetes prevention programs in achieving objectively verified weight loss relative to a standard care control at comparatively lower costs. Adult patients (18 years of age and older) at risk for developing diabetes will be randomized to either the Choice group or the Randomization group. Those patients randomized to the Choice group (n=240) will have the opportunity to choose one of two programs to participate in: 1. A 2-hour Small-Group (SG) session, with automated interactive voice response (IVR) systems targeting personal action planning to support lifestyle change and weight loss over a period of 12 months; or 2. A DVD-based intervention with the same IVR follow-up. Those patients assigned to the RCT group (n=360) will be randomized to one of three groups: 1. SG/IVR; 2. DVD/IVR; or 3. Enhanced standard-care (SC). SC includes the referral to a currently offered pre-diabetes class. Primary outcome measures include weight loss, cost, and reach of each
Interventions
- BEHAVIORAL Choice-Class with IVR Calls
- BEHAVIORAL Random-Class with IVR calls
- BEHAVIORAL Random-Class only
- BEHAVIORAL Choice-DVD with IVR calls
- BEHAVIORAL Random-DVD with IVR calls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2014-03-13 |
| Est. Completion | 2017-04-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02162901
The ClinicalTrials.gov registry entry for NCT02162901 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 597 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Polytechnic Institute and State University, which has 104 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Choice-Class with IVR Calls is the first listed.
NCT02162901 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02162901 about?
NCT02162901 is a clinical study titled "The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs". The aim of this project is to evaluate the reach, effectiveness, and costs of two patient-centered, theory-based, technology-enhanced diabetes prevention programs to initiate and sustain weight loss among pre-diabetic adults (i.e. impaired fasting glucose or impaired glucose tolerance) within a heal...
What is the current status of trial NCT02162901?
This trial is currently completed. It is a NA study. The enrollment target is 597 participants. The study started on 2014-03-13. Estimated completion is 2017-04-28.
What interventions are being tested in trial NCT02162901?
The interventions under investigation include: Choice-Class with IVR Calls (BEHAVIORAL), Random-Class with IVR calls (BEHAVIORAL), Random-Class only (BEHAVIORAL), Choice-DVD with IVR calls (BEHAVIORAL), Random-DVD with IVR calls (BEHAVIORAL).
Who is sponsoring clinical trial NCT02162901?
This trial is sponsored by Virginia Polytechnic Institute and State University, which has 104 total clinical trials registered on ClinicalTrials.gov.
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