Control Systems Engineering for Weight Loss Maintenance

ConditionOverweight and Obesity

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorThe Miriam Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

180 Participants

are divided into 1 treatment group

Group A: System IdentificationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

Weight change

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

Time frame