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Completed

NCT Number: NCT04522245

Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention

The aim of this study is to compare brain changes in individuals with overweight or obesity enrolled in either the Noom Healthy Weight program or a matched control. The study objectives (primary and secondary) are to measure brain change reported as ERP and EEG data over a 16-week timeframe. Additionally, we will explore changes in the default mode network (resting-state asymmetry in EEG measurements), changes in executive functioning, quality of life, mood, and salivary markers as they relate to EEG data.

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Key information

Conditions

Obesity Behavior Behavior, Health Body Weight Body Weight Changes Color Vision Defects Cone Dystrophy Eye Diseases Eye Diseases, Hereditary Health Behavior Nervous System Diseases Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Focus Feedback

Commack, New York, 11725, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Each subject must be able to understand and provide informed consent
  • Between the ages 18-60 years
  • Self-report of good health
  • Overweight or obesity (BMI ≥ 25)
  • Able to meet our criteria of adherence to the program
  • Able to attend in-person visit in Long Island, NY

Exclusion criteria

  • Inability or unwillingness to give written informed consent or comply with the study
  • Visual impairment that cannot be corrected with glasses or contact lenses
  • Any indication of drug, alcohol or medicine abuse.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
  • Presence of a brain injury, psychiatric disorders, seizure disorders, and other neurological conditions
  • Reported eating disorder
  • Currently pregnant or 6 months postpartum
  • Planning to become pregnant within the next 5 months

Treatment and study plan

Noom Healthy Weight; mobile behavior change program for weight loss.

Behavioral

The mobile cognitive behavior change program follows guidelines from the Obesity Society's "2013 Guidelines for the Management of Overweight and Obesity in Adults" NIH "Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults".

There are 52 weeks of curriculum with 1-3 articles to read per day. Users are requested to perform weight logging once daily and food logging after each meal. Users are assigned human coaches and are able to interact with them via in-app messaging or phone communication. Users are also assigned to support groups via in-app messaging.

Matched Control

Other

Matched control group (Noom-branded 'healthy eating' short guide on weight loss).

Primary outcomes

  1. Change in Flanker task performance: Intervention vs control

    Time frame: 16 weeks

    Change in amplitude and latency in conflict monitoring stage at 16 weeks

  2. Change in behavioral inhibition

    Time frame: 16 weeks

    Change from baseline Flanker task performance at 16 weeks

  3. Change in behavioral inhibition

    Time frame: 16 weeks

    Change from baseline n-back task performance at 16 weeks

  4. Change in behavioral inhibition

    Time frame: 16 weeks

    Change from baseline Stroop test at 16 weeks

Secondary outcomes

  1. Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control

    Time frame: 16-week

    Task-specific event-related potential (ERP) peak amplitude and latency for channels and

    • Task-specific event-related potential (ERP) peak amplitude and latency for channels and cortical ROIs
    • Event-related spectral perturbation (time x frequency power) for channels and cortical ROIs
    • Mean and relative power spectral density measures for each frequency band + select ratios, for channels and cortical ROIs
    • Brain connectivity between cortical ROIs

  2. Comparison of EEG data in program starters to successful program completers

    Time frame: 16-week

    • Task-specific event-related potential (ERP) peak amplitude and latency for channels and cortical ROIs
    • Event-related spectral perturbation (time x frequency power) for channels and cortical ROIs
    • Mean and relative power spectral density measures for each frequency band + select ratios, for channels and cortical ROIs
    • Brain connectivity between cortical ROIs

  3. Within-subject comparison for EEG data

    Time frame: 16-week

    • Task-specific event-related potential (ERP) peak amplitude and latency for channels and cortical ROIs
    • Event-related spectral perturbation (time x frequency power) for channels and cortical ROIs
    • Mean and relative power spectral density measures for each frequency band + select ratios, for channels and cortical ROIs
    • Brain connectivity between cortical ROIs

Other outcomes

  1. Change in Positive and Negative Affect Schedule (PANAS-SF)

    Time frame: 16-week

    Explore measure as it relates to change in EEG data

  2. Change in quality of life outcome measure scoring (PROMIS-29)

    Time frame: 16-week

    Explore measure as it relates to change in EEG data

  3. Change in eating behavior measure scoring (Three-Factor Eating Questionnaire)

    Time frame: 16-week

    Explore measure as it relates to change in EEG data

  4. Change from baseline salivary stress marker at 16 weeks

    Time frame: 16-week

    Cortisol

  5. Change from baseline salivary tumor necrosis factor alpha at 16 weeks

    Time frame: 16-week

    TNF-a

  6. Change from baseline salivary interleukin-6 at 16 weeks

    Time frame: 16-week

    IL-6

  7. Change from baseline blood pressure (systolic/diastolic) at 16 weeks

    Time frame: 16-week

Sponsors and collaborators

Lead sponsor

Noom Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Jul 20, 2021

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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