NCT06244888 Control Systems Engineering for Weight Loss Maintenance
| NCT ID | NCT06244888 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The Miriam Hospital |
| Condition | Overweight and Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2027-12-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2024-02-26 with a primary completion date of 2027-12-31.
⚠ 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
This project capitalizes on principles of control systems engineering to build a dynamical model that predicts weight change during weight loss maintenance using behavioral, psychosocial, and environmental indicators evaluated in a system identification experiment. A 6-month behavioral obesity treatment will be administered to produce weight loss. Participants losing at least 3% of initial body weight will be followed for an additional 12 months via daily smartphone surveys that incorporates passive sensing to objectively monitor key behaviors. Survey data pertaining to behavioral, psychosocial, and environmental indicators will be used to develop a controller algorithm that can predict when an individual is entering a heightened period of risk for regain and why risk is elevated. Interventions targeting key risk indicators will be randomly administered during the system ID experiment. Survey and passive sensing data documenting the effects of the interventions will likewise drive development of the controller algorithm, allowing it to determine which interventions are most likely to counter risk of regain.
Eligibility Criteria
Inclusion Criteria: * English language fluent and literate at the 6th grade level * Body mass index (BMI) between 25 and 50 kg/m-squared * Able to walk 2 city blocks without stopping * Owns a smartphone Exclusion Criteria: * Report of a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling. * Currently participating in another weight loss program * Currently taking weight loss medication * Has lost ≥5% of body weight in the 6 months prior to enrolling * Has been pregnant within the 6 months prior to enrolling * Plans to become pregnant within 18 months of enrolling * Any medical condition that would affect the safety of participating in unsupervised physical activity * Any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06244888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Overweight and Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06244888 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06244888 currently recruiting?
Yes, NCT06244888 is actively recruiting participants. Contact the research team at sotoole@lifespan.org for enrollment information.
Where is the NCT06244888 trial being conducted?
This trial is being conducted at Providence, United States.
Who is sponsoring the NCT06244888 clinical trial?
NCT06244888 is sponsored by The Miriam Hospital. The trial plans to enroll 180 participants.
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