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

NCT04522245 | Completed

• 1 other identifier: Pro00042660
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Behavior, Health; Weight Loss

Keywords

EEG, mhealth, weight loss, CBT, cognitive behavior therapy

Outcome Measures

Primary Outcomes (4)

• Change in Flanker task performance: Intervention vs control

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

  16 weeks

• Change in behavioral inhibition

  Change from baseline Flanker task performance at 16 weeks

  16 weeks

• Change in behavioral inhibition

  Change from baseline n-back task performance at 16 weeks

  16 weeks

• Change in behavioral inhibition

  Change from baseline Stroop test at 16 weeks

  16 weeks

Secondary Outcomes (3)

• 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

• Within-subject comparison for EEG data

  16-week

Other Outcomes (7)

• Change in Positive and Negative Affect Schedule (PANAS-SF)

  16-week

• Change in quality of life outcome measure scoring (PROMIS-29)

  16-week

• Change in eating behavior measure scoring (Three-Factor Eating Questionnaire)

  16-week

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Matched Control

Noom Health Weight Program

EXPERIMENTAL

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

Interventions

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

Noom Health Weight Program

Matched Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noom Inc.: lead

Study Sites (1)

Focus Feedback

Commack, New York, 11725, United States

Location

MeSH Terms

Conditions

Obesity; Health Behavior; Weight Loss; Color Vision Defects

Interventions

Case-Control Studies

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andreas Michaelides, PhD

  Chief of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Psychology

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 21, 2020
• Study Start: October 1, 2020
• Primary Completion: March 15, 2021
• Study Completion: July 15, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)