ObesityNCT04522245
Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention
A study testing Noom Healthy Weight; mobile behavior change program for weight loss. in people with Obesity and Behavior, Health, run by Noom Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Behavior, Health, Weight Loss
- What is being tested?
- Noom Healthy Weight; mobile behavior change program for weight loss.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 15 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Noom Healthy Weight; mobile behavior change program for weight loss., Matched Control
- Keywords
- EEG, mhealth, weight loss, CBT, cognitive behavior therapy
- Medical subject headings
- Obesity, Health Behavior, Weight Loss, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom Healthy Weight; mobile behavior change program for weight loss.Behavioural
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.
Matched ControlOther
Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Matched control group (Noom-branded 'healthy eating' short guide on weight loss). Receives: Other: Matched Control |
| Noom Health Weight Program | Experimental | Not described Receives: Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flanker task performance: Intervention vs control
Change in amplitude and latency in conflict monitoring stage at 16 weeks
Measured: 16 weeks
Change in behavioral inhibition
Change from baseline Flanker task performance at 16 weeks
Measured: 16 weeks
Change in behavioral inhibition
Change from baseline n-back task performance at 16 weeks
Measured: 16 weeks
Change in behavioral inhibition
Change from baseline Stroop test at 16 weeks
Measured: 16 weeks
Secondary outcomes (3)
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
- Task-specific event-related potential (ERP) peak amplitude and latency for channels and cortical ROIs
- Event-related spectral perturbation (time x frequency power) for channels and cortical ROIs
- Mean and relative power spectral density measures for each frequency band + select ratios, for channels and cortical ROIs
- Brain connectivity between cortical ROIs
Measured: 16-week
Comparison of EEG data in program starters to successful program completers
- Task-specific event-related potential (ERP) peak amplitude and latency for channels and cortical ROIs
- Event-related spectral perturbation (time x frequency power) for channels and cortical ROIs
- Mean and relative power spectral density measures for each frequency band + select ratios, for channels and cortical ROIs
- Brain connectivity between cortical ROIs
Measured: 16-week
Within-subject comparison for EEG data
- Task-specific event-related potential (ERP) peak amplitude and latency for channels and cortical ROIs
- Event-related spectral perturbation (time x frequency power) for channels and cortical ROIs
- Mean and relative power spectral density measures for each frequency band + select ratios, for channels and cortical ROIs
- Brain connectivity between cortical ROIs
Measured: 16-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Oct 2020
- Primary completion15 Mar 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noom Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Andreas Michaelides, Noom Inc.
- Investigators
- Andreas Michaelides, PhD, Principal investigator, Chief of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522245
- Sponsor's protocol ID
- Pro00042660
- Status last verified
- Jul 2021
- First submitted
- 4 Aug 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT04522245
- Acronym / sponsor ID
- Pro00042660
- Conditions
- Obesity, Behavior, Health, Weight Loss
- Keywords
- EEG, mhealth, weight loss, CBT, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Matched ControlMatched control group (Noom-branded 'healthy eating' short guide on weight loss). |
| Noom Health Weight Program | Experimental | Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Noom Health Weight Program |
| Matched ControlMatched control group (Noom-branded 'healthy eating' short guide on weight loss). | Other | Control |
Primary outcome
Change in Flanker task performance: Intervention vs control
Time frame: 16 weeks
Change in amplitude and latency in conflict monitoring stage at 16 weeks
Change in behavioral inhibition
Time frame: 16 weeks
Change from baseline Flanker task performance at 16 weeks
Change in behavioral inhibition
Time frame: 16 weeks
Change from baseline n-back task performance at 16 weeks
Change in behavioral inhibition
Time frame: 16 weeks
Change from baseline Stroop test at 16 weeks
3 secondary outcomes
Change in EEG data: Successful intervention (5% weight loss) in higher engagement subgroup (successful program completers) vs control
Time frame: 16-week
Comparison of EEG data in program starters to successful program completers
Time frame: 16-week
Within-subject comparison for EEG data
Time frame: 16-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Michaelides, PhD principal investigator
Chief of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noom Healthy Weight; mobile behavior change program for weight loss. in people with Obesity and Behavior, Health, run by Noom Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flanker task performance: Intervention vs control (time frame: 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.