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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Behavior, Health, Weight Loss

Intervention / Treatment
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* Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.
* Other: Matched Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Matched control group (Noom-branded 'healthy eating' short guide on weight loss). | Other: Matched Control<br>* Matched control group (Noom-branded 'healthy eating' short guide on weight loss).<br>|
| Experimental: Noom Health Weight Program<br> | Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flanker task performance: Intervention vs control | Change in amplitude and latency in conflict monitoring stage at 16 weeks | 16 weeks | 
| Change in behavioral inhibition | Change from baseline Flanker task performance at 16 weeks | 16 weeks | 
| Change in behavioral inhibition | Change from baseline n-back task performance at 16 weeks | 16 weeks | 
| Change in behavioral inhibition | Change from baseline Stroop test at 16 weeks | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control | 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 | 16-week | 
| Comparison of EEG data in program starters to successful program completers | 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 | 16-week | 
| Within-subject comparison for EEG data | 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 | 16-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, mhealth, weight loss, CBT, cognitive behavior therapy