Overview
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.
Eligibility
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