Clinical trial NCT04116853: Support and Tracking to Achieve Results (Project STAR)
Official title: Evaluation of an Adaptive Intervention for Weight Loss Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Weight Maintenance
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-10-07
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All randomized participants will receive extended-care intervention delivered via phone; however, the frequency/timing of these calls will vary between the ADAPTIVE and STATIC conditions.
Primary purpose: TREATMENT

Brief 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

Detailed description: Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight and obesity, long-term outcomes are suboptimal, limiting effectiveness for long-term weight loss maintenance.

The study team will evaluate methods for providing phone-based extended-care to support weight loss maintenance. The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when we determine that participants are at "high risk" for weight regain) vs. STATIC (once-per-month frequency used in gold-standard extended-care programs) schedule on weight loss maintenance. Participants will be provided with an initial in-person, group-based behavioral weight management program. Participants who successfully achieve a clinically-significant weight loss between baseline and Month 4 (defined by the Institute of Medicine as a reduction in weight of ≥ 5% from baseline) will be randomized into the clinical trial. Follow-up visits will occur at Month 12 and Month 24 after initial intervention baseline.

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)

Primary outcomes:
measure: Change in weight regain of the ADAPTIVE group compared to the STATIC group
timeFrame: Baseline; Month 4; Month 12; Month 24
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Kathryn Ross, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ross KM, Carpenter CA, Arroyo KM, Shankar MN, Yi F, Qiu P, Anthony L, Ruiz J, Perri MG. Impact of transition from face-to-face to telehealth on behavioral obesity treatment during the COVID-19 pandemic. Obesity (Silver Spring). 2022 Apr;30(4):858-863. doi: 10.1002/oby.23383. Epub 2022 Mar 11.
citation: Ross KM, Shankar MN, Qiu P, Tian Z, Swanson TN, Shetty A, Ruiz J, Anthony L, Perri MG. Design of Project STAR: A randomized controlled trial evaluating the impact of an adaptive intervention on long-term weight-loss maintenance. Contemp Clin Trials. 2024 Nov;146:107707. doi: 10.1016/j.cct.2024.107707. Epub 2024 Oct 9.