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NCT02214641 · ClinicalTrials.gov registry record · NA
Resilient, Empowered, Active Living: REAL Diabetes Study
A NA study, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 81
- Enrollment target
NCT02214641 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 81 participants.
The verdict
NCT02214641, a NA study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 81 participants
- Enrollment target
Study Summary
This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention. The study's specific aims and hypotheses are as follows: Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care. Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants. Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT). Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants. Hypothesis 2: At 6 months, intervention group
Interventions
- BEHAVIORAL Resilient, Empowered, Active Living with Diabetes
- BEHAVIORAL Information Control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2014-10 |
| Est. Completion | 2017-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02214641
The ClinicalTrials.gov registry entry for NCT02214641 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Resilient, Empowered, Active Living with Diabetes is the first listed.
NCT02214641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02214641 about?
NCT02214641 is a clinical study titled "Resilient, Empowered, Active Living: REAL Diabetes Study". This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assess...
What is the current status of trial NCT02214641?
This trial is currently completed. It is a NA study. The enrollment target is 81 participants. The study started on 2014-10. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02214641?
The interventions under investigation include: Resilient, Empowered, Active Living with Diabetes (BEHAVIORAL), Information Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT02214641?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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