Control Systems Engineering for Weight Loss Maintenance

Phase 2

Recruiting

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Intervention Targeting Stress and Emotion Regulation; Behavioral: Intervention Targeting Motivation and Self-efficacy for Weight Management; Behavioral: Intervention for Normalization of Eating; Behavioral: Intervention Targeting Physical Activity and Sleep

• Registration Number: NCT06244888
• Lead Sponsor: The Miriam Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-18
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-06
• Study Start: 2024-02-26
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
System Identification	Intervention Targeting Stress and Emotion Regulation	All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.
System Identification	Intervention for Normalization of Eating	All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.
System Identification	Intervention Targeting Motivation and Self-efficacy for Weight Management	All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.
System Identification	Intervention Targeting Physical Activity and Sleep	All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Weight change	Every day during the 52-week system identification experiment	This will be measured throughout the system identification experiment using a consumer scale with internet connectivity.

Secondary Outcome Measures

Name	Time	Method
Weight Locus of Control	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the Multidimensional Health Locus of Control scale for smartphone administration.
Affect	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the Profile of Mood States and Positive and Negative Affect States for smartphone administration.
Self-efficacy	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the short-form Weight Efficacy Lifestyle Questionnaire for smartphone administration.
Intervention engagement	Every day during the 52-week system identification experiment	Intervention engagement will be measured by the smartphone application that delivers intervention. Engagement is defined as the count of clicks to open intervention resources.
Weight Control Strategies Intentions and Implementation	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the Weight Control Strategies scale for smartphone administration.
Dysregulated Eating	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration.
Sleep	Every day during the 52-week system identification experiment	Wrist-worn accelerometer-measured sleep timing, duration \& quality.
Perceived Benefit of Weight Control	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the Beliefs about Dietary Compliance Scale and the Exercise Benefits/Barriers scale for smartphone administration.
Hunger and Cravings	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration.
Stress	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from Cohen's Stress Scale for smartphone administration.
Social Support	Every day during the 52-week system identification experiment	Mean scale score of questionnaire items adapted from the short-form Multidimensional Scale of Perceived Social Support for smartphone administration.
Physical Activity	Every day during the 52-week system identification experiment	Wrist-worn accelerometer-measured minutes per day of physical activity.
Dietary Lapse	Every day during the 52-week system identification experiment	Count of self-reported instances of unintended eating, eating larger portions than one intended, and eating foods that one intended to avoid

Trial Locations

Locations (1)

Miriam Hospital Weight Control and Diabetes Resarch Center; 🇺🇸 Providence, Rhode Island, United States