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

Not Applicable

Completed

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

• Registration Number: NCT04522245
• Lead Sponsor: Noom Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-21
• Study Start: 2020-10-01
• Primary Completion: 2021-03-15
• Status Verified: 2021-07
• Study Completion: 2021-07-15
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Matched Control	Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
Noom Health Weight Program	Noom Healthy Weight; mobile behavior change program for weight loss.	-

Primary Outcome Measures

Name	Time	Method
Change in behavioral inhibition	16 weeks	Change from baseline Stroop test at 16 weeks
Change in Flanker task performance: Intervention vs control	16 weeks	Change in amplitude and latency in conflict monitoring stage at 16 weeks

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Focus Feedback; 🇺🇸 Commack, New York, United States