Clinical trial

Control Systems Engineering for Weight Loss Maintenance

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06244888

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionOverweight and Obesity

Full registry 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

Treatments and study arms

Intervention Targeting Stress and Emotion Regulation

Behavioral

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

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.

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.

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.

Primary outcomes

Weight changeEvery day during the 52-week system identification experiment

This will be measured throughout the system identification experiment using a consumer scale with internet connectivity.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

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

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Sharon O'Toole, M.A.T.Contact

Email · Call 401-793-8992