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ObesityNCT03887078

Noom Coach for Bariatric Health

A study testing Noom Coach for Bariatric Health in people with Obesity, run by Noom Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled… 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
14 Sep 2018to 7 Sep 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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Enrolled in: (1) the Metabolic, Endocrine, and Minimally Invasive Surgery Division at Mount Sinai 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 (Wechsler Abbreviated Scale of Intelligence IQ Estimate < 70) or history of developmental disability.
  • History of neurological disorder or injury (e.g., seizure disorder or moderate or severe head injury with >10 minutes loss of consciousness).
  • Current/lifetime DSM-5 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.

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery

Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. As more Americans consider bariatric surgery for the treatment of severe obesity, it is imperative to improve factors influencing suboptimal surgical outcomes (e.g., failure to adhere to diet and exercise recommendations and psychosocial impairment). This study will evaluate the effect of the Noom Coach for Bariatric Health platform in improving standard interventions utilized in bariatric surgery programs.

Read the detailed description

Overweight and obesity have reached epidemic proportions in the United States. As few behavioral treatments are effective for weight loss, bariatric surgery is an increasingly important option. Although these procedures are more helpful than psychosocial treatments, post-operative weight losses vary widely, and a notable subset of patients demonstrate suboptimal weight loss or substantial weight regain. Adherence to treatment recommendations is a likely contributor to these variable outcomes. Smartphone applications (apps) designed to augment behavior change or enhance adherence, have expanded exponentially in recent years, and are a potentially useful option to improve outcomes, but rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. This study will test a combined smartphone app and health coaching system to improve adherence and behavioral/psychosocial outcomes for patients receiving bariatric surgery. The aims have not been modified since the original phase 1 and will compare usual pre-operative care and pre-surgical use of Noom Coach for Bariatric Health on post-surgery adherence and psychosocial variables in a larger test (n=200) to explore whether usage of the app is a viable predictor of subsequent post-operative weight trajectories 12 months following surgery. This study will also examine app usage as a viable predictor of subsequent post-operative weight and psychosocial trajectories in the 12 months post-surgery and establish sensitivity and specificity of early optimal response to surgical intervention using weight loss, diet and exercise adherence, and psychosocial adjustment.

Conditions
Obesity
Being tested
Noom Coach for Bariatric Health
Keywords
Obesity, Bariatric Surgery, mHealth
Medical subject headings
Obesity

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 pre and or post-surgery.

Study groups in NCT03887078
Study groupRoleWhat they receive
A. Presurgery Noom Bariatric + Augmentation Noom BariatricExperimentalSelf-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. Intervention responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.
Receives: Behavioral: Noom Coach for Bariatric Health
B. Presurgery Noom Bariatric + Augmentation Standard CareExperimentalSelf-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. Intervention responsive individuals will be randomized post-surgery to "usual care" in which participants are free to seek any assistance for their bariatric post-surgery care during the study period.
Receives: Behavioral: Noom Coach for Bariatric Health
C. Presurgery Noom Bariatric + Augmentation Noom BariatricExperimentalSelf-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. Intervention non-responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.
Receives: Behavioral: Noom Coach for Bariatric Health
D. Presurgery Noom Bariatric + Augmentation Standard CareExperimentalSelf-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. Intervention non-responsive individuals will be randomized post-surgery to "usual care" in which participants are free to seek any assistance for their bariatric post-surgery care during the study period.
Receives: Behavioral: Noom Coach for Bariatric Health
E. Pre-surgery Standard Care + Augmentation Noom BariatricExperimentalThe 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. Usual care responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.
Receives: Behavioral: Noom Coach for Bariatric Health
F. Pre-surgery Standard Care + Augmentation Standard CareNo interventionThe 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. Usual care responsive individuals will be randomized post-surgery to usual care.
G. Pre-surgery Standard Care + Augmentation Noom BariatricExperimentalThe 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. Usual care non-responsive individuals will be randomized post-surgery to Noom Bariatric augmentation.
Receives: Behavioral: Noom Coach for Bariatric Health
H. Pre-surgery Standard Care + Augmentation Standard CareNo interventionThe 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. Usual care non-responsive individuals will be randomized post-surgery to usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, 8 weeks, 3 months, and 12 months

  2. 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: Baseline, 8 weeks, 3 months, and 12 months

  3. 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, 8 weeks, 3, 6, 9, and 12 months

  4. Anthropometric changes (weight)

    To calculate trajectories of BMI, measures of height (inches) and weight (pounds) will be obtained at all in-person visits.

    Measured: Baseline, 8 weeks, 3, 6, and 12 months

  5. Anthropometric changes (height)

    To calculate trajectories of BMI, measures of height (inches) and weight (pounds) will be obtained at all in-person visits.

    Measured: Baseline, 8 weeks, 3, 6, and 12 months

Secondary outcomes (3)

  1. Eating Disorder Examination Questionnaire (EDE-Q)

    Change in EDE-Q 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, 8 weeks, 3, 6, 9, and 12 months

  2. Depression Anxiety Stress Scales (DASS)

    Change in symptoms of depression, anxiety, and stress from baseline. 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, 8 weeks, 3, 6, 9, and 12 months

  3. 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, 8 weeks, 3, 6, 9, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start14 Sep 2018
  3. Primary completion7 Sep 2021
  4. Study completion7 Sep 2021

Resources

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
Sequential
Model description
Two successive randomizations based on patterned response to primary intervention. Pre-surgical participants (n=200) will be randomized to groups in Noom Coach for Bariatric Health or standard care pre-surgery. Post-surgery, optimal and suboptimal responders will be randomized to Noom Bariatric or standard care. This design allows for comparisons between all 8 conditions. Contrasts allow us to answer the critical question about main effects of Noom Pre-surgery and Noom augmentation and whether this augmentation effect differs based on empirically derived classification of early response.
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887078
Sponsor's protocol ID
R44DK116370
Status last verified
May 2023
First submitted
17 Mar 2019
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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, 8 weeks, 3 months, and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887078.

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.

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