Behavior, Health, Obesity, Weight Loss
Conditions
Keywords
EEG, mhealth, weight loss, CBT, cognitive behavior therapy
Brief summary
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.
Interventions
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.
OTHERMatched Control
Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
Sponsors
Noom Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Flanker task performance: Intervention vs control | 16 weeks | Change in amplitude and latency in conflict monitoring stage at 16 weeks |
| Change in behavioral inhibition | 16 weeks | Change from baseline Flanker task performance at 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control | 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 |
| Comparison of EEG data in program starters to successful program completers | 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 |
| Within-subject comparison for EEG data | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline salivary interleukin-6 at 16 weeks | 16-week | IL-6 |
| Change in Positive and Negative Affect Schedule (PANAS-SF) | 16-week | Explore measure as it relates to change in EEG data |
| Change from baseline blood pressure (systolic/diastolic) at 16 weeks | 16-week | — |
| Change in quality of life outcome measure scoring (PROMIS-29) | 16-week | Explore measure as it relates to change in EEG data |
| Change in eating behavior measure scoring (Three-Factor Eating Questionnaire) | 16-week | Explore measure as it relates to change in EEG data |
| Change from baseline salivary stress marker at 16 weeks | 16-week | Cortisol |
| Change from baseline salivary tumor necrosis factor alpha at 16 weeks | 16-week | TNF-a |
Countries
United States
Outcome results
None listed