Stepped Care for Weight Loss Maintenance
Purpose
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: 1. Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss. 2. 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. 3. 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.
Condition
- Obesity
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Usual care |
Usual care |
|
|
Experimental Text-message intervention with digital tools (SELF) |
Text-message intervention |
|
|
Experimental Stepped Care (STEP) |
Stepped care |
|
Recruiting Locations
Baltimore, Maryland 21205
More Details
- NCT ID
- NCT06151145
- Status
- Recruiting
- Sponsor
- Johns Hopkins University