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

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Noom

Status

Completed

Conditions

Weight Loss
Obesity
Behavior, Health

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04522245
Pro00042660

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
Treatment:
Other: Matched Control
Noom Health Weight Program
Experimental group
Treatment:
Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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