NCT06151145Active, not recruiting
Stepped Care for Weight Loss Maintenance
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 192 (actual)
- First submitted
- 21 Nov 2023
- Start date
- 1 Feb 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Obesity
- NCT number
- NCT06151145
What you commit to
- Study type: Interventional
- Participants enrolled: 192
- From 1 Feb 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recently began a course of or changed the dosage of medication that can cause significant change in weight
- Weight loss of \>5% in the previous 6 months
Other illness
- 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
- History of bariatric surgery
Other
- 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
- Household member already participating in study
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.