Control Systems Engineering for Weight Loss Maintenance

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sharon O'Toole, M.A.T.; Phone Number: 401 793-8992; Email: sotoole@lifespan.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Miriam Hospital Weight Control and Diabetes Resarch Center
      • Contact: Sharon O'Toole, M.A.T.; Phone Number: 401-793-8992; Email: sotoole@lifespan.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: System Identification; 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.

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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): February 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 422620; 1R01DK137423 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will make data and documentation available under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
• IPD Sharing Access Criteria: A data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No