Behavioral weight loss maintenance program
Stepped Care for Weight Loss Maintenance
This study is testing different ways to help adults with obesity keep off weight they lost after a 16-week program, to see which method works best for long-term weight maintenance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06151145 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a 16-week behavioral weight loss treatment followed by a 52-week stepped-care digital health intervention for maintaining weight loss in adults with obesity. Participants will first undergo a run-in phase to achieve a minimum weight loss of 5% before being randomized into one of three maintenance strategies. These strategies include usual care with educational modules, a SELF group with digital health tools, and a STEP group with additional support. The goal is to determine which approach best supports long-term weight maintenance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a BMI of 30 or higher, or 27 or higher with obesity-related complications, who can engage in physical activity.
Not a fit: Patients with serious medical or psychiatric conditions, those who are pregnant, or individuals who have recently lost significant weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective strategies for long-term weight maintenance in individuals with obesity.
How similar studies have performed: Other studies have shown success with behavioral interventions for weight loss maintenance, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ariana M Chao, PhD, CRNP — Johns Hopkins University
- Study coordinator: Ariana M Chao, PhD, CRNP
- Email: ariana.chao@jhu.edu
- Phone: 4432876223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.