Support and Tracking to Achieve Results (Project STAR)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of an Adaptive Intervention for Weight Loss Maintenance

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: ADAPTIVE Extended-Care Program
* Behavioral: STATIC Extended-Care Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADAPTIVE Extended-Care Group<br>Participants randomized to the ADAPTIVE extended-care program will receive extended-care intervention phone delivered only if either 1) an algorithm developed by our study team detects that a participant is at high risk for weight regain or 2) the participant self-initiates a request for a session. | Behavioral: ADAPTIVE Extended-Care Program<br>* Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.<br>|
| Active Comparator: STATIC Extended-Care Group<br>Participants randomized to the STATIC extended-care program will receive the extended-care intervention phone calls on a fixed, once-per-month schedule (the schedule currently used in gold-standard weight maintenance programs). | Behavioral: STATIC Extended-Care Program<br>* Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight regain of the ADAPTIVE group compared to the STATIC group | Participant body weight will be measured at the screening visit as well as all assessment visits by trained research staff using calibrated Tanita digital scales, with participants in light indoor clothing, with pockets emptied and belts and shoes removed. | Baseline; Month 4; Month 12; Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Weight Maintenance