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NCT Number: NCT06244888

Control Systems Engineering for Weight Loss Maintenance

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miriam Hospital Weight Control and Diabetes Resarch Center

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Sharon O'Toole, M.A.T.

CONTACT

[email protected]

401-793-8992

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Weight change

    Time frame: Every day during the 52-week system identification experiment

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

Secondary outcomes

  1. Intervention engagement

    Time frame: Every day during the 52-week system identification experiment

    Intervention engagement will be measured by the smartphone application that delivers intervention. Engagement is defined as the count of clicks to open intervention resources.

  2. Weight Locus of Control

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the Multidimensional Health Locus of Control scale for smartphone administration.

  3. Perceived Benefit of Weight Control

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the Beliefs about Dietary Compliance Scale and the Exercise Benefits/Barriers scale for smartphone administration.

  4. Weight Control Strategies Intentions and Implementation

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the Weight Control Strategies scale for smartphone administration.

  5. Hunger and Cravings

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration.

  6. Affect

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the Profile of Mood States and Positive and Negative Affect States for smartphone administration.

  7. Stress

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from Cohen's Stress Scale for smartphone administration.

  8. Self-efficacy

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the short-form Weight Efficacy Lifestyle Questionnaire for smartphone administration.

  9. Sleep

    Time frame: Every day during the 52-week system identification experiment

    Wrist-worn accelerometer-measured sleep timing, duration & quality.

  10. Social Support

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the short-form Multidimensional Scale of Perceived Social Support for smartphone administration.

  11. Physical Activity

    Time frame: Every day during the 52-week system identification experiment

    Wrist-worn accelerometer-measured minutes per day of physical activity.

  12. Dysregulated Eating

    Time frame: Every day during the 52-week system identification experiment

    Mean scale score of questionnaire items adapted from the Three Factor Eating Questionnaire for smartphone administration.

  13. Dietary Lapse

    Time frame: Every day during the 52-week system identification experiment

    Count of self-reported instances of unintended eating, eating larger portions than one intended, and eating foods that one intended to avoid

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon O'Toole, M.A.T.

CONTACT

[email protected]

401 793-8992

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2024
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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