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NCT03202420 · ClinicalTrials.gov registry record · NA
Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT03202420 is a NA study that has completed, run by Duke University. The registered enrollment target is 26 participants.
The verdict
NCT03202420, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics. To achieve these goals, the investigators will pursue the following Specific Aims: Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups. Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants. Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks. Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.
Interventions
- OTHER TOPS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2017-12-22 |
| Est. Completion | 2019-12-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03202420
The ClinicalTrials.gov registry entry for NCT03202420 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TOPS is the first listed.
NCT03202420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03202420 about?
NCT03202420 is a clinical study titled "Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic". The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future rand...
What is the current status of trial NCT03202420?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2017-12-22. Estimated completion is 2019-12-05.
What interventions are being tested in trial NCT03202420?
The interventions under investigation include: TOPS (OTHER).
Who is sponsoring clinical trial NCT03202420?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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