Support and Tracking to Achieve Results (Project STAR) (NCT04116853) | Clinical Trial Compass
CompletedNot Applicable
Support and Tracking to Achieve Results (Project STAR)
United States255 participantsStarted 2019-10-17
Plain-language 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
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared an 'ADAPTIVE' approach to a 'STATIC' approach for weight loss — can you explain what the difference between these two strategies actually means in practice, and whether either one aligns with how you'd recommend I manage my weight?
2The trial tracked weight change from month 4 all the way to month 24, which suggests a long-term commitment — given my current health situation and lifestyle, do you think I could realistically sustain a two-year structured weight management program like this one?
3Since this study is now completed, has any data been published yet showing whether the adaptive group actually maintained better weight loss than the static group, and what would those results mean for my own treatment options?
4This trial is listed as 'Phase NA,' meaning it's more of a behavioral or lifestyle intervention study rather than a drug trial — does that change how you'd weigh the evidence from it compared to other obesity treatments you might recommend for me?
5Given that the study focused on weight change after an initial weight loss phase, are there standard obesity treatments or programs already available that use a similar adaptive approach, so I might benefit from those findings without needing to join a study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in Weight Change Month 4 to Month 24 of the ADAPTIVE Group Compared to the STATIC Group, Controlling for Initial Weight Loss