Control Systems Engineering for Weight Loss Maintenance

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244888
• Other study ID #: 422620
• Secondary ID: 1R01DK137423
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: The Miriam Hospital
• Contact: Sharon O'Toole, M.A.T.
• Phone: 401 793-8992
• Email: sotoole[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

Behavioral:
• Intervention Targeting Stress and Emotion Regulation
This intervention involves learning and practicing relaxation exercises and setting aside time for pleasurable activities.
• 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.
• 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.
• 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

Country	Name	City	State
United States	Miriam Hospital Weight Control and Diabetes Resarch Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sleep	Wrist-worn accelerometer-measured sleep timing, duration & quality.	Every day during the 52-week system identification experiment
Secondary	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
Secondary	Physical Activity	Wrist-worn accelerometer-measured minutes per day of physical activity.	Every day during the 52-week system identification experiment
Secondary	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
Secondary	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