NCT06244888

Control Systems Engineering for Weight Loss Maintenance

Name: Clinical Trial NCT06244888
Creator: The Miriam Hospital
Keywords: Overweight and Obesity, Intervention Targeting Stress and Emotion Regulation, Phase 2, behavioral, clinical trial, United States of America

Control Systems Engineering to Address the Problem of Weight Loss Maintenance: A System Identification Experiment to Model Behavioral & Psychosocial Factors Measured by Ecological Momentary Assessment

The Miriam Hospital·Phase 2·ClinicalTrials.gov·behavioralRecruiting

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Study focus

Disease/Condition: Overweight and Obesity
Drug/Device/Intervention: Intervention Targeting Stress and Emotion Regulation
Study type: Interventional
Intervention type: behavioral

Sponsor & location

Primary sponsor: The Miriam Hospital
Location: Providence, United States of America

Timeline & enrollment

Phase: Phase 2
Start date: Feb 12, 2024
End date: Dec 31, 2027
Enrollment: 180 participants

Primary outcome

Weight change

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.

ICD-10 classifications

ObesityOther obesityObesity due to excess caloriesObesity, unspecifiedObesity and other hyperalimentation

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06244888
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06244888 through Pure Global AI's free database. This Phase 2 trial is sponsored by The Miriam Hospital and is currently Recruiting. The study focuses on Overweight and Obesity. Target enrollment is 180 participants.

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