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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04522245
Other study ID # Pro00042660
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date July 15, 2021

Study information

Verified date July 2021
Source Noom Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 15, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Focus Feedback Commack New York

Sponsors (1)

Lead Sponsor Collaborator
Noom Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Positive and Negative Affect Schedule (PANAS-SF) Explore measure as it relates to change in EEG data 16-week
Other Change in quality of life outcome measure scoring (PROMIS-29) Explore measure as it relates to change in EEG data 16-week
Other Change in eating behavior measure scoring (Three-Factor Eating Questionnaire) Explore measure as it relates to change in EEG data 16-week
Other Change from baseline salivary stress marker at 16 weeks Cortisol 16-week
Other Change from baseline salivary tumor necrosis factor alpha at 16 weeks TNF-a 16-week
Other Change from baseline salivary interleukin-6 at 16 weeks IL-6 16-week
Other Change from baseline blood pressure (systolic/diastolic) at 16 weeks 16-week
Primary Change in Flanker task performance: Intervention vs control Change in amplitude and latency in conflict monitoring stage at 16 weeks 16 weeks
Primary Change in behavioral inhibition Change from baseline Flanker task performance at 16 weeks 16 weeks
Primary Change in behavioral inhibition Change from baseline n-back task performance at 16 weeks 16 weeks
Primary Change in behavioral inhibition Change from baseline Stroop test at 16 weeks 16 weeks
Secondary 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
Secondary 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
Secondary 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
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