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RECRUITING
NCT06244888
PHASE2

Control Systems Engineering for Weight Loss Maintenance

Sponsor: The Miriam Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2024-02-26

Completion Date

2027-12-31

Last Updated

2024-04-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Intervention Targeting Stress and Emotion Regulation

This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.

BEHAVIORAL

Intervention Targeting Motivation and Self-efficacy for Weight Management

This intervention involves identifying values related to weight, lifestyle, and health; identifying barriers to value-consistent living; exploring the consequences of letting barriers drive behavior; and 4) setting goals that are small, specific, attainable, and values-consistent.

BEHAVIORAL

Intervention for Normalization of Eating

This intervention involves dietary self-monitoring with the goal of staying within a calorie goal ranging from 1,200 kcal/day to 1,800 kcal/day. Participants are also provided with meal planning tools and encouraged to addresses hunger and cravings by promoting feelings of satiety via consumption of foods that are high in volume but low in calories.

BEHAVIORAL

Intervention Targeting Physical Activity and Sleep

This simple intervention prompts participants at the start of the day to schedule up to 30 minutes of moderate-to-vigorous intensity physical activity; brisk walking is encouraged. Participants also set a bedtime and wake time and are encouraged to set a reminder alarm to ensure at least 8 hours of sleep.

Locations (1)

Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, United States