Stepped Care for Weight Loss Maintenance
Public ClinicalTrials.gov record NCT06151145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06151145
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 192 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1, 2024 (Actual)
- Primary completion
- Jun 2028 (Estimated)
- Completion
- Jun 2028 (Estimated)
- Last update posted
- Jun 15, 2026
2024 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06151145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 15, 2026 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06151145 live on ClinicalTrials.gov.