Recruiting
Phase 2

Weight Loss

Sponsor:

The Miriam Hospital

Code:

NCT06244888

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Overweight and Obesity

Study ID

NCT06244888

Start date

Feb 26, 2024

Status verified date

Jan, 2024

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Intervention Targeting Stress and Emotion Regulation

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

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 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 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 measure

  • Weight change [ Time Frame: Every day during the 52-week system identification experiment ]

Central Contacts and Locations

Central contacts

Sharon O'Toole, M.A.T.

401 793-8992sotoole@lifespan.org

Locations

Miriam Hospital Weight Control and Diabetes Resarch Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Sharon O'Toole, M.A.T.

401-793-8992sotoole@lifespan.org

More Information

Sponsor

The Miriam Hospital

Last update posted

Apr 2, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2024-04-02.