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

Noom Inc.70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obesity Behavior, Health Weight Loss

Interventions

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 ControlOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Focus Feedback

Commack, New York, United States

Outcomes

Primary Outcomes

Change in Flanker task performance: Intervention vs control

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

Time frame: 16 weeks

Change in behavioral inhibition

Change from baseline Flanker task performance at 16 weeks

Time frame: 16 weeks

Change in behavioral inhibition

Change from baseline n-back task performance at 16 weeks

Time frame: 16 weeks

Change in behavioral inhibition

Change from baseline Stroop test at 16 weeks

Time frame: 16 weeks

Secondary Outcomes

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

Time frame: 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

Data from ClinicalTrials.gov

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