Control Systems Engineering for Weight Loss Maintenance

NCT ID: NCT06244888

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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System Identification

All participants who lose at least 3% of their initial body weight will be asked to participate in a system identification experiment every day for 52 weeks.

Group Type EXPERIMENTAL

Intervention Targeting Stress and Emotion Regulation

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Intervention Targeting Stress and Emotion Regulation

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon O'Toole, M.A.T.

Role: CONTACT

401 793-8992

Facility Contacts

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Sharon O'Toole, M.A.T.

Role: primary

401-793-8992

Other Identifiers

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1R01DK137423

Identifier Type: NIH

Identifier Source: secondary_id

View Link

422620

Identifier Type: -

Identifier Source: org_study_id

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