Clinical trial NCT04522245: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Behavior, Health
Weight Loss
Keywords: EEG, mhealth, weight loss, CBT, cognitive behavior therapy
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Flanker task performance: Intervention vs control
timeFrame: 16 weeks
measure: Change in behavioral inhibition
timeFrame: 16 weeks
measure: Change in behavioral inhibition
timeFrame: 16 weeks
measure: Change in behavioral inhibition
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control
timeFrame: 16-week
measure: Comparison of EEG data in program starters to successful program completers
timeFrame: 16-week
measure: Within-subject comparison for EEG data
timeFrame: 16-week
Other outcomes:
measure: Change in Positive and Negative Affect Schedule (PANAS-SF)
timeFrame: 16-week
measure: Change in quality of life outcome measure scoring (PROMIS-29)
timeFrame: 16-week
measure: Change in eating behavior measure scoring (Three-Factor Eating Questionnaire)
timeFrame: 16-week
measure: Change from baseline salivary stress marker at 16 weeks
timeFrame: 16-week
measure: Change from baseline salivary tumor necrosis factor alpha at 16 weeks
timeFrame: 16-week
measure: Change from baseline salivary interleukin-6 at 16 weeks
timeFrame: 16-week
measure: Change from baseline blood pressure (systolic/diastolic) at 16 weeks
timeFrame: 16-week
Locations:
city: Commack
country: United States
facility: Focus Feedback
state: New York
Study officials:
affiliation: Chief of Psychology
name: Andreas Michaelides, PhD
role: PRINCIPAL_INVESTIGATOR
References: