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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Matched control group (Noom-branded 'healthy eating' short guide on weight loss). |
|
| Noom Health Weight Program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive and Negative Affect Schedule (PANAS-SF) | Explore measure as it relates to change in EEG data | 16-week |
| Change in quality of life outcome measure scoring (PROMIS-29) | Explore measure as it relates to change in EEG data |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michaelides, PhD | Chief of Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Focus Feedback | Commack | New York | 11725 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015438 | Health Behavior |
| D015431 | Weight Loss |
| D003117 | Color Vision Defects |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016022 | Case-Control Studies |
| ID | Term |
|---|---|
| D016021 | Epidemiologic Studies |
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| Matched Control | Other | Matched control group (Noom-branded 'healthy eating' short guide on weight loss). |
|
| 16-week |
| Comparison of EEG data in program starters to successful program completers |
| 16-week |
| Within-subject comparison for EEG data |
| 16-week |
| 16-week |
| Change in eating behavior measure scoring (Three-Factor Eating Questionnaire) | Explore measure as it relates to change in EEG data | 16-week |
| Change from baseline salivary stress marker at 16 weeks | Cortisol | 16-week |
| Change from baseline salivary tumor necrosis factor alpha at 16 weeks | TNF-a | 16-week |
| Change from baseline salivary interleukin-6 at 16 weeks | IL-6 | 16-week |
| Change from baseline blood pressure (systolic/diastolic) at 16 weeks | 16-week |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000077765 | Cone Dystrophy |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |