NCT04116853Completed
Support and Tracking to Achieve Results (Project STAR)
Evaluation of an Adaptive Intervention for Weight Loss Maintenance
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 255 (actual)
- First submitted
- 3 Oct 2019
- Start date
- 17 Oct 2019
- Primary completion date
- 5 Nov 2024
- Lead sponsor
- University of Florida
- Diseases
- Obesity
- NCT number
- NCT04116853
What you commit to
- Study type: Interventional
- Participants enrolled: 255
- From 17 Oct 2019 to the primary completion date, 5 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of weight loss medications
- Weight loss of ≥ 10 lb in prior 6 months
Other illness
- History of bariatric surgery
- Lack of written approval for participation from potential participant's physician if the participant has been diagnosed with type 2 diabetes, hypertension, or has a history of coronary heart disease
- Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, or plans to relocate during the study period)
Other
- Physical limitations that prevent walking ¼ mile without stopping
- Use of a pacemaker
- Currently pregnant
- Currently breastfeeding
- Less than 1 year post-partum
- Plans to become pregnant within the study period
- More than one participant per household (enrollment limited to one participant per household)
Who the study is looking for
- BMI 30.0-45.0 kg/m2
- Own a smartphone \[Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)\] with a cellular and data plan
- Weight ≤ 396 pounds (due to scale limit)
- Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)
- Completion of baseline assessment measures
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
Related publications
- Changes in Ultra-Processed Food Intake During a Single-Arm Behavioral Weight Management Intervention: A Secondary Analysis.Obesity (Silver Spring) · 2026 · PMID 42446055
This page is information, not medical advice. Discuss any trial with your doctor.