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

NCT ID: NCT04522245

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-15

Brief Summary

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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

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Conditions

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Obesity Behavior, Health Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Matched Control

Intervention Type OTHER

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

Noom Health Weight Program

Group Type EXPERIMENTAL

Noom Healthy Weight; mobile behavior change program for weight loss.

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Matched Control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Noom Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Dr. Andreas Michaelides

Chief of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Michaelides, PhD

Role: PRINCIPAL_INVESTIGATOR

Chief of Psychology

Locations

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Focus Feedback

Commack, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00042660

Identifier Type: -

Identifier Source: org_study_id

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