ObesityNCT03386006
Noom Coach for Bariatric Surgery
A study testing Noom Coach for Bariatric Health in people with Obesity, run by Noom Inc. at 1 site in United States.
Trial summary
The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Noom Coach for Bariatric Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 9 Nov 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
- Between the ages of 18 and 60 at entry to the study.
- Speak English.
Who cannot join
- Clinically significant cognitive limitations or history of developmental disability.
- History of neurological disorder or injury.
- Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
- Acute suicide risk.
- Current DSM-5 alcohol or substance use disorder.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery
The prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Technology, particularly the Noom Coach platform, offers a unique opportunity to improve standard interventions utilized in bariatric surgery programs. This study plans to test the efficacy of the Noom Coach platform on patients' adherence behaviors and psychosocial factors compared to standard care.
Read the detailed description
Overweight and obesity have reached epidemic proportions in the United States. Few behavioral treatments are effective for overweight, and bariatric surgery is consequently an increasingly important option. Although these procedures produce significantly more weight change than psychosocial treatments, post-operative weight losses vary widely, about 20% of patients clearly experience suboptimal weight loss, and a notable subset of these patients demonstrate substantial weight regain. Further, 20-30% report persistence of disturbed eating, depression or anxiety, or impaired health related quality of life. Adherence, or "the extent to which a person's behavior coincides with medical or health advice," contributes to variable weight and psychosocial outcomes, as well as failure to follow dietary guidelines, each of which negatively impacts weight loss.
The present study, utilizing "Noom Coach for Bariatric Health", offers a unique opportunity to overcome obstacles to providing empirically supported treatments and to improve standard interventions utilized in bariatric surgery programs; however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. The project will therefore test a combined smartphone app and health coaching system to improve adherence and behavioral outcomes for patients receiving bariatric surgery.
- Conditions
- Obesity
- Being tested
- Noom Coach for Bariatric Health
- Keywords
- bariatric surgery, mobile health (mHealth), psychosocial functioning, obesity, weight loss, behavioral activation
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom Coach for Bariatric HealthBehavioural
Noom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Noom Coach for Bariatric Health | Experimental | Self-monitoring will be conducted through Noom Coach for Bariatric Health, and individuals will receive a specialized set of instructions on how to use the app. Receives: Behavioral: Noom Coach for Bariatric Health |
| Usual Care | No intervention | The control group will be a "usual care" condition in which participants are free to seek any assistance for their bariatric surgery care during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence to dietary recommendations
Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.
Measured: Baseline and 8 weeks
Change in adherence to physical activity recommendations (Activity Tracker)
Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.
Measured: Ongoing
Change in adherence to physical activity recommendations (IPAQ)
Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.
Measured: Baseline and 8 weeks
Secondary outcomes (3)
Eating Disorder Examination Questionnaire (EDE-Q)
Change in EDE-Q at 8 weeks as compared to baseline. Questionnaire to assess for eating disorder symptomology. A 28 item measure with 4 subscales of restraint, eating concern, shape concern, and weight concern. Scores range from 0-168 with higher scores indicating more severe eating disorder pathology. Average scores on each subscale are used in addition to an average global score.
Measured: Baseline and 8 weeks
Depression Anxiety Stress Scales (DASS)
Change in symptoms of depression, anxiety, and stress at baseline and 8 weeks. A 42-item self-report questionnaire assessing three related negative emotional states: depression, anxiety, and stress. Items are scored on a 0-3 Likert scale with ranges within each emotional state for normal, mild, moderate, severe and extremely severe symptoms. Higher scores indicate more severe symptoms. Ranges in severity are reported as sum scores for each emotion state. Depression includes normal (0-9), mild (10-13), moderate (14-20), severe (21-27), extremely severe (28+). Anxiety includes normal (0-7), mild (8-9), moderate (10-14), severe (15-19) extremely severe (20+) Stress includes normal (0-14), mild (15-18) , moderate (19-25), severe (26-33) extremely severe (34+).
Measured: Baseline and 8 weeks
Short Form-36 Health Survey (SF-36)
The SF-36 is a 10-item self-report of health-related quality of life measure that generates eight scaled scored. Individual items are scored 0-100 with higher scores indicating a more favorable health state. The eight subscales, reported as weighted means as (0-100) for each scale, include physical functioning, bodily pain, role limitations due to physical health, role limitations due to personal and emotional problems, emotional well being, social functioning, energy/fatigue, general health perceptions.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start5 Dec 2017
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noom Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386006
- Sponsor's protocol ID
- R44DK116370
- Status last verified
- May 2023
- First submitted
- 30 Oct 2017
- Last updated
- 22 May 2023
- 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 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03386006
- Acronym / sponsor ID
- R44DK116370
- Conditions
- Obesity
- Keywords
- bariatric surgery, mobile health (mHealth), psychosocial functioning, obesity, weight loss, behavioral activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 29 Dec 2017 (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 prevalence of overweight in America is a national public health crisis. As more people consider bariatric surgery for the treatment of severe obesity, it is imperative to identify factors influencing surgical outcomes. Technology, particularly the Noom Coach platform, offers a unique opportunity to improve standard interventions utilized in bariatric surgery programs. This study plans to test the efficacy of the Noom Coach platform on patients' adherence behaviors and psychosocial factors compared to standard care.
Detailed description
Overweight and obesity have reached epidemic proportions in the United States. Few behavioral treatments are effective for overweight, and bariatric surgery is consequently an increasingly important option. Although these procedures produce significantly more weight change than psychosocial treatments, post-operative weight losses vary widely, about 20% of patients clearly experience suboptimal weight loss, and a notable subset of these patients demonstrate substantial weight regain. Further, 20-30% report persistence of disturbed eating, depression or anxiety, or impaired health related quality of life. Adherence, or "the extent to which a person's behavior coincides with medical or health advice," contributes to variable weight and psychosocial outcomes, as well as failure to follow dietary guidelines, each of which negatively impacts weight loss.
The present study, utilizing "Noom Coach for Bariatric Health", offers a unique opportunity to overcome obstacles to providing empirically supported treatments and to improve standard interventions utilized in bariatric surgery programs; however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. The project will therefore test a combined smartphone app and health coaching system to improve adherence and behavioral outcomes for patients receiving bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noom Coach for Bariatric Health | Experimental | Behavioral: Noom Coach for Bariatric HealthSelf-monitoring will be conducted through Noom Coach for Bariatric Health, and individuals will receive a specialized set of instructions on how to use the app. |
| Usual Care | No intervention | –The control group will be a "usual care" condition in which participants are free to seek any assistance for their bariatric surgery care during the study period. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Enrolled in: the Mount Sinai Bariatric Surgery Program and planning to receive a bariatric procedure.
- Between the ages of 18 and 60 at entry to the study.
- Speak English.
Key exclusion criteria (6 listed)
- Clinically significant cognitive limitations or history of developmental disability.
- History of neurological disorder or injury.
- Current/lifetime Diagnostic and Statistical Manual of Mental Disorders (DSM-5) serious psychiatric disorder, such as bipolar disorder, schizophrenia, or psychotic disorder.
- Acute suicide risk.
- Current DSM-5 alcohol or substance use disorder.
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 Coach for Bariatric HealthNoom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks. | Behavioural | Noom Coach for Bariatric Health |
Primary outcome
Change in adherence to dietary recommendations
Time frame: Baseline and 8 weeks
Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.
Change in adherence to physical activity recommendations (Activity Tracker)
Time frame: Ongoing
Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.
Change in adherence to physical activity recommendations (IPAQ)
Time frame: Baseline and 8 weeks
Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.
3 secondary outcomes
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Baseline and 8 weeks
Depression Anxiety Stress Scales (DASS)
Time frame: Baseline and 8 weeks
Short Form-36 Health Survey (SF-36)
Time frame: Baseline and 8 weeks
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 22 May 2023.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coach for Bariatric Health in people with Obesity, 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 3 inclusion and 6 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 22 May 2023. 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. 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 adherence to dietary recommendations (time frame: Baseline and 8 weeks). The study lists 3 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 22 May 2023.