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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522245
• Other study ID #: Pro00042660
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Behavior, Health
• Body Weight
• Obesity
• Weight Loss

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