Stepped Care for Weight Loss Maintenance

Study Overview
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Brief Summary
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This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss. 16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet. 52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups: Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. Participants in the SELF group will receive a wireless smart body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance. Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.

Official Title
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Stepped Care for Weight Loss Maintenance

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Usual care
* Behavioral: SELF
* Behavioral: STEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI>/=30 kg/m2 or >/=27 kg/m2 with an obesity-related complication Age 18-70 years Completion of baseline assessment tasks Ability to engage in physical activity Own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers Home wireless access Exclusion Criteria: Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program Pregnant or planning pregnancy in the next 1.5 years Weight>440 lbs Planned move out of the area in the next 1.5 years Recently began a course of or changed the dosage of medication that can cause significant change in weight History of bariatric surgery Weight loss of >5% in the previous 6 months Household member already participating in study

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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Accepts Healthy Volunteers

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care | Behavioral: Usual care<br>* Participants in usual care will be emailed monthly educational modules with information on maintaining weight loss.<br>|
| Experimental: Text-message intervention with digital tools (SELF)<br>Text-message intervention | Behavioral: SELF<br>* The SELF group will receive a wireless smart body weight scale and wearable physical activity tracker, and text messages.<br>|
| Experimental: Stepped Care (STEP)<br>Stepped care | Behavioral: STEP<br>* The STEP intervention consists of 4 steps that are progressive and based on response to treatment. Step 1: Digital health intervention. The first step will be the digital health intervention as described under SELF. Step 2: Monthly, in-person counseling. Participants who move to Step 2 will be provided with monthly, in-person counseling. Step 3: Twice per month counseling. Step 3 will be twice-monthly counseling, spaced at every other week. Step 4: Meal replacements. Participants will be prescribed a partial meal replacement program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight (kg) change for STEP versus usual care | Weight change (kg) for STEP versus usual care | Baseline, 52 weeks | 
| Weight (kg) change for SELF versus usual care | Weight change (kg) for SELF versus usual care | Baseline, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-weighing frequency (days) for STEP and SELF versus usual care | Change in number of days of self-weighing for STEP and SELF versus usual care | Baseline, 52 weeks | 
| Change in daily calorie intake for STEP and SELF vs usual care | Change in daily calorie intake measured using 24-hour dietary recalls for STEP and SELF versus usual care | Baseline, 52 weeks | 
| Change in physical activity (minutes) for STEP and SELF versus usual care | Change in self-reported minutes of physical activity for STEP and SELF versus usual care | Baseline, 52 weeks | 
| Weight (kg) change for STEP versus SELF | Weight change (kg) for STEP versus SELF | Baseline, 52 weeks | 
| Change in days of self-weighing for STEP versus SELF | Self-weighing frequency for STEP versus SELF | Baseline, 52 weeks | 
| Change in daily calorie intake for STEP versus SELF | Change in daily calorie intake measured using 24-hour dietary recalls for STEP versus SELF | Baseline, 52 weeks | 
| Change in self-reported minutes of Physical activity for STEP versus SELF | Change in self-reported minutes of physical activity for STEP versus SELF | Baseline, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, weight loss