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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss; Behavior, Health
• Intervention / Treatment: Other: Matched Control; Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Commack, New York, United States, 11725
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control; Matched control group (Noom-branded 'healthy eating' short guide on weight loss).	Other: Matched Control; Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
EXPERIMENTAL: Noom Health Weight Program	Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Positive and Negative Affect Schedule (PANAS-SF)	Explore measure as it relates to change in EEG data	16-week
Change in quality of life outcome measure scoring (PROMIS-29)	Explore measure as it relates to change in EEG data	16-week
Change in eating behavior measure scoring (Three-Factor Eating Questionnaire)	Explore measure as it relates to change in EEG data	16-week
Change from baseline salivary stress marker at 16 weeks	Cortisol	16-week
Change from baseline salivary tumor necrosis factor alpha at 16 weeks	TNF-a	16-week
Change from baseline salivary interleukin-6 at 16 weeks	IL-6	16-week
Change from baseline blood pressure (systolic/diastolic) at 16 weeks		16-week

Collaborators and Investigators

• Sponsor: Noom Inc.
• Investigators: Principal Investigator: Andreas Michaelides, PhD, Chief of Psychology

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ACTUAL): July 15, 2021

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (ACTUAL): August 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: EEG, mhealth, weight loss, CBT, cognitive behavior therapy
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: Pro00042660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No