N/A
N=255
Support and Tracking to Achieve Results (Project STAR)
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04116853 ↗Enrolled (actual)
255
Serious AEs
10.2%
Results posted
Oct 2025
Primary outcome: Primary: Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss — 99.57; 100.22; 90.18; 90.59 Weight (kg)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ADAPTIVE Extended-Care Program (Behavioral); STATIC Extended-Care Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss |
99.57; 100.22; 90.18; 90.59; 89.18; 90.15 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- History of bariatric surgery
- Current use of weight loss medications
- Weight loss of ≥ 10 lb in prior 6 months
- 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
- 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
- More than one participant per household (enrollment limited to one participant per household)
- 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)
Data sourced from ClinicalTrials.gov (NCT04116853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.