Control Systems Engineering for Weight Loss Maintenance

NCT06244888 | Recruiting Phase 2

• 2 other identifiers: 4226201R01DK137423
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Intervention engagement

  Every day during the 52-week system identification experiment

• Weight Locus of Control

  Every day during the 52-week system identification experiment

• Perceived Benefit of Weight Control

  Every day during the 52-week system identification experiment

• Weight Control Strategies Intentions and Implementation

  Every day during the 52-week system identification experiment

• Hunger and Cravings

  Every day during the 52-week system identification experiment

Study Arms (1)

System Identification

EXPERIMENTAL

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; Behavioral: Intervention Targeting Motivation and Self-efficacy for Weight Management; Behavioral: Intervention for Normalization of Eating; Behavioral: Intervention Targeting Physical Activity and Sleep

Interventions

Intervention Targeting Stress and Emotion Regulation BEHAVIORAL

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

System Identification

Intervention Targeting Motivation and Self-efficacy for Weight Management BEHAVIORAL

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.

System Identification

Intervention for Normalization of Eating BEHAVIORAL

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.

System Identification

Intervention Targeting Physical Activity and Sleep BEHAVIORAL

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.

System Identification

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Methods; Sleep

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Sharon O'Toole, M.A.T.

CONTACT

401 793-8992; sotoole@lifespan.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: See study description for details. All participants will receive all intervention elements, with allocation varying randomly across time using procedures appropriate for system identification.

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 6, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)