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NCT04116853 · ClinicalTrials.gov registry record · NA
Support and Tracking to Achieve Results (Project STAR)
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 255
- Enrollment target
NCT04116853: Completed NA study, sponsored by University of Florida.
NCT04116853 is a NA study that has completed, run by University of Florida. The registered enrollment target is 255 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04116853, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 255 participants
- Enrollment target
Study Summary
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule on weight loss maintenance. The study team will provide participants with an initial behavioral weight management program, and then randomize participants who successfully achieve a clinically-significant weight loss of ≥5% to one of the two extended-care conditions
Primary Outcome
Participant body weight will be measured at baseline, Month 4, Month 12, and Month 24 using study-provided BodyTrace e-scales. Participants will be asked to measure their weight first thing in the morning on a scheduled assessment day, before having anything to eat or drink but after using the restroom, in no more than light indoor clothing and with pockets emptied and shoes removed. Analyses will examine difference in weight change from Month 4 to 24 by group, controlling for initial weight los
Interventions
- BEHAVIORAL ADAPTIVE Extended-Care Program
- BEHAVIORAL STATIC Extended-Care Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2024-11-05 |
| Phase | NA |
What the finished NCT04116853 record still lists
NCT04116853 is an interventional study that assigns participants to a tested intervention. The registered 255 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which ADAPTIVE Extended-Care Program is the first listed.
NCT04116853 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04116853 about?
NCT04116853 is a clinical study titled "Support and Tracking to Achieve Results (Project STAR)". The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as assessed by a predictive algorithm) vs. STATIC (gold-standard, once-per-month frequency) schedule o...
What is the current status of trial NCT04116853?
This trial is currently completed. It is a NA study. The enrollment target is 255 participants. The study started on 2019-10-17. Estimated completion is 2024-11-05.
What interventions are being tested in trial NCT04116853?
The interventions under investigation include: ADAPTIVE Extended-Care Program (BEHAVIORAL), STATIC Extended-Care Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT04116853?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04116853's enrollment target sits among peer trials
255 407th of 2000 higher than 1,594 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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