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Overweight and ObesityPhase 2NCT06244888

Control Systems Engineering for Weight Loss Maintenance

A Phase 2 study testing Intervention Targeting Stress and Emotion Regulation, Intervention Targeting Motivation and Self-efficacy for Weight Management and Intervention for Normalization of Eating in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Intervention Targeting Stress and Emotion Regulation, Intervention Targeting Motivation and Self-efficacy for Weight Management and Intervention for Normalization of Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
26 Feb 2024to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sharon O'Toole, M.A.T. contact

401 793-8992

sotoole@lifespan.org

United States1 site, 1 recruiting

  • Miriam Hospital Weight Control and Diabetes Resarch Center

    Providence, Rhode Island, 02903

    Sharon O'Toole, M.A.T., 401-793-8992, sotoole@lifespan.org

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
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
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention Targeting Stress and Emotion RegulationBehavioural

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

  • Intervention Targeting Motivation and Self-efficacy for Weight ManagementBehavioural

    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 EatingBehavioural

    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 SleepBehavioural

    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.

Study groups in NCT06244888
Study groupRoleWhat they receive
System IdentificationExperimentalAll 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.
Receives: Behavioral: Intervention Targeting Stress and Emotion Regulation; Behavioral: Intervention Targeting Motivation and Self-efficacy for Weight Management; Behavioral: Intervention for Normalization of Eating; Behavioral: Intervention Targeting Physical Activity and Sleep

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight change

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

    Measured: Every day during the 52-week system identification experiment

Secondary outcomes (13)

  1. Intervention engagement

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

    Measured: Every day during the 52-week system identification experiment

  2. Weight Locus of Control

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

    Measured: Every day during the 52-week system identification experiment

  3. Perceived Benefit of Weight Control

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

    Measured: Every day during the 52-week system identification experiment

  4. Weight Control Strategies Intentions and Implementation

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

    Measured: Every day during the 52-week system identification experiment

  5. Hunger and Cravings

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

    Measured: Every day during the 52-week system identification experiment

  6. Affect

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

    Measured: Every day during the 52-week system identification experiment

  7. Stress

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

    Measured: Every day during the 52-week system identification experiment

  8. Self-efficacy

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

    Measured: Every day during the 52-week system identification experiment

  9. Sleep

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

    Measured: Every day during the 52-week system identification experiment

  10. Social Support

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

    Measured: Every day during the 52-week system identification experiment

  11. Physical Activity

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

    Measured: Every day during the 52-week system identification experiment

  12. Dysregulated Eating

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

    Measured: Every day during the 52-week system identification experiment

  13. Dietary Lapse

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

    Measured: Every day during the 52-week system identification experiment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2024
  2. Study start26 Feb 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06244888
Sponsor's protocol ID
422620
Other IDs
1R01DK137423
Status last verified
Jan 2024
First submitted
18 Jan 2024
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will make data and documentation available under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intervention Targeting Stress and Emotion Regulation, Intervention Targeting Motivation and Self-efficacy for Weight Management and Intervention for Normalization of Eating in people with Overweight and Obesity, run by The Miriam Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sharon O'Toole, M.A.T. (401 793-8992, sotoole@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight change (time frame: Every day during the 52-week system identification experiment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06244888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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