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

Primary Purpose

Obesity, Behavior, Health, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight; mobile behavior change program for weight loss.
Matched Control
Sponsored by
Noom Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring EEG, mhealth, weight loss, CBT, cognitive behavior therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Focus Feedback

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Noom Health Weight Program

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
August 4, 2020
Last Updated
July 19, 2021
Sponsor
Noom Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04522245
Brief Title
Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention
Official Title
Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Noom Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Behavior, Health, Weight Loss
Keywords
EEG, mhealth, weight loss, CBT, cognitive behavior therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
Arm Title
Noom Health Weight Program
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight; mobile behavior change program for weight loss.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Matched Control
Intervention Description
Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
Primary Outcome Measure Information:
Title
Change in Flanker task performance: Intervention vs control
Description
Change in amplitude and latency in conflict monitoring stage at 16 weeks
Time Frame
16 weeks
Title
Change in behavioral inhibition
Description
Change from baseline Flanker task performance at 16 weeks
Time Frame
16 weeks
Title
Change in behavioral inhibition
Description
Change from baseline n-back task performance at 16 weeks
Time Frame
16 weeks
Title
Change in behavioral inhibition
Description
Change from baseline Stroop test at 16 weeks
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control
Description
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
Time Frame
16-week
Title
Comparison of EEG data in program starters to successful program completers
Description
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
Time Frame
16-week
Title
Within-subject comparison for EEG data
Description
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
Time Frame
16-week
Other Pre-specified Outcome Measures:
Title
Change in Positive and Negative Affect Schedule (PANAS-SF)
Description
Explore measure as it relates to change in EEG data
Time Frame
16-week
Title
Change in quality of life outcome measure scoring (PROMIS-29)
Description
Explore measure as it relates to change in EEG data
Time Frame
16-week
Title
Change in eating behavior measure scoring (Three-Factor Eating Questionnaire)
Description
Explore measure as it relates to change in EEG data
Time Frame
16-week
Title
Change from baseline salivary stress marker at 16 weeks
Description
Cortisol
Time Frame
16-week
Title
Change from baseline salivary tumor necrosis factor alpha at 16 weeks
Description
TNF-a
Time Frame
16-week
Title
Change from baseline salivary interleukin-6 at 16 weeks
Description
IL-6
Time Frame
16-week
Title
Change from baseline blood pressure (systolic/diastolic) at 16 weeks
Time Frame
16-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michaelides, PhD
Organizational Affiliation
Chief of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Focus Feedback
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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