| NCT ID | NCT05799846 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Miriam Hospital |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2023-03-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are: * Which of the three Internet-delivered weight loss programs results in the greatest weight loss? * How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? * What individual characteristics predict success in each arm? * What are the underlying mechanisms of each approach? * Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns). Participants will: * signed informed consent * complete a baseline assessment * be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE * complete a training workshop to learn arm-specific cognitive strategies * complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons * complete an assessment at 3 months (during treatment) * complete a refresher workshop on arm-specific cognitive strategies at 3 months * complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment
Eligibility Criteria
Inclusion Criteria: * Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work. Exclusion Criteria: * Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI. Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.
Frequently Asked Questions
Who can join the NCT05799846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05799846 currently recruiting?
Yes, NCT05799846 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Miriam Hospital to inquire about joining.
Where is the NCT05799846 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT05799846 clinical trial?
NCT05799846 is sponsored by The Miriam Hospital. The trial plans to enroll 360 participants.
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