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Clinical Trials/NCT04522245
NCT04522245
Completed
Not Applicable

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

Noom Inc.1 site in 1 country70 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Noom Inc.
Enrollment
70
Locations
1
Primary Endpoint
Change in behavioral inhibition
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
July 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Noom Inc.
Responsible Party
Principal Investigator
Principal Investigator

Dr. Andreas Michaelides

Chief of Psychology

Noom Inc.

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in behavioral inhibition

Time Frame: 16 weeks

Change from baseline Stroop test at 16 weeks

Change in Flanker task performance: Intervention vs control

Time Frame: 16 weeks

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

Secondary Outcomes

  • Within-subject comparison for EEG data(16-week)
  • Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control(16-week)
  • Comparison of EEG data in program starters to successful program completers(16-week)

Study Sites (1)

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