Control Systems Engineering for Weight Loss Maintenance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention Targeting Stress and Emotion Regulation, Intervention Targeting Motivation and Self-efficacy for Weight Management, Intervention for Normalization of Eating, Intervention Targeting Physical Activity and Sleep.
- Who it may be relevant to
- Registry conditions: Overweight and Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- Weight change [Time frame: Every day during the 52-week system identification experiment]
Secondary outcome measures (12)
- Intervention engagement [Time frame: Every day during the 52-week system identification experiment]
- Weight Locus of Control [Time frame: Every day during the 52-week system identification experiment]
- Perceived Benefit of Weight Control [Time frame: Every day during the 52-week system identification experiment]
- Weight Control Strategies Intentions and Implementation [Time frame: Every day during the 52-week system identification experiment]
- Hunger and Cravings [Time frame: Every day during the 52-week system identification experiment]
- Affect [Time frame: Every day during the 52-week system identification experiment]
- Stress [Time frame: Every day during the 52-week system identification experiment]
- Self-efficacy [Time frame: Every day during the 52-week system identification experiment]
- Sleep [Time frame: Every day during the 52-week system identification experiment]
- Social Support [Time frame: Every day during the 52-week system identification experiment]
- Physical Activity [Time frame: Every day during the 52-week system identification experiment]
- Dysregulated Eating [Time frame: Every day during the 52-week system identification experiment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Miriam Hospital Weight Control and Diabetes Resarch Center — Providence
Identifiers
NCT: NCT06244888 · 422620 · 1R01DK137423