Clinical trial NCT06244888: Control Systems Engineering for Weight Loss Maintenance
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Overweight and Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-02-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: See study description for details. All participants will receive all intervention elements, with allocation varying randomly across time using procedures appropriate for system identification.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight change
timeFrame: Every day during the 52-week system identification experiment
Secondary outcomes:
measure: Intervention engagement
timeFrame: Every day during the 52-week system identification experiment
measure: Weight Locus of Control
timeFrame: Every day during the 52-week system identification experiment
measure: Perceived Benefit of Weight Control
timeFrame: Every day during the 52-week system identification experiment
measure: Weight Control Strategies Intentions and Implementation
timeFrame: Every day during the 52-week system identification experiment
measure: Hunger and Cravings
timeFrame: Every day during the 52-week system identification experiment
measure: Affect
timeFrame: Every day during the 52-week system identification experiment
measure: Stress
timeFrame: Every day during the 52-week system identification experiment
measure: Self-efficacy
timeFrame: Every day during the 52-week system identification experiment
measure: Sleep
timeFrame: Every day during the 52-week system identification experiment
measure: Social Support
timeFrame: Every day during the 52-week system identification experiment
measure: Physical Activity
timeFrame: Every day during the 52-week system identification experiment
measure: Dysregulated Eating
timeFrame: Every day during the 52-week system identification experiment
measure: Dietary Lapse
timeFrame: Every day during the 52-week system identification experiment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Miriam Hospital Weight Control and Diabetes Resarch Center
state: Rhode Island
Study officials:
References: