ObesityNCT04645108
Coached or Non-Coached Weight Loss Intervention
A study testing Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching and 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
To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Behavior, Health, Behavior, Eating
- What is being tested?
- Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching and Noom Healthy Weight; mobile behavior change program for weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 10 Jun 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and provide informed consent
- 18-65 years old
- Self-report of good health (physical and mental)
- Not diagnosed with diabetes
- Overweight or obesity (BMI ≥ 27)
- Able to meet our criteria of adherence to the program (at least 1 engagement per week on one of the following: logged exercise, logged meals, steps, weigh-ins, coach messages, read articles, and days with at least one weigh-in.) For females
- Not 6 months postpartum
- Not planning to become pregnant in the next 5 months.
Who cannot join
- Inability or unwillingness of a participant to give written informed consent
- Currently pregnant or ≤ 6 months postpartum
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data E.g., evidence of an eating disorder, major chronic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention
To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.
- Conditions
- Obesity, Behavior, Health, Behavior, Eating, Weight Loss, Overweight and Obesity, Self Efficacy
- Being tested
- Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching, Noom Healthy Weight; mobile behavior change program for weight loss
- Medical subject headings
- Obesity, Health Behavior, Feeding Behavior, Weight Loss, Overweight
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 with 1:1 coachingBehavioural
The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach.
Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily.
Noom Healthy Weight; mobile behavior change program for weight lossBehavioural
The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity. During the first week of the study, participants will be introduced to the program, and the Noom app.
| Study group | Role | What they receive |
|---|---|---|
| Coached | Experimental | Not described Receives: Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching |
| No Coach | Active comparator | 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.
Weight
Self reported
Measured: 4 months
Self reported in app engagement measures
self reported and automatically logged
Measured: 4 months
Secondary outcomes (5)
Quality of Life Via SF-12
Self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure
Measured: 4 months
Eating Behavior via the Dutch Eating Behavior Questionnaire
The Dutch Eating Behavior Questionnaire (DEBQ) assesses the structure of an individual's eating behavior. the DEBQ contains separate scales for emotional, external, and restrained eating behavior.
Measured: 4 months
Resilience via Devereux Adult Resilience Survey
Provides insights into personal strengths
Measured: 4 months
Self Efficacy via General Self-Efficacy Scale
The scale was created to assess a general sense of perceived self-efficacy with the aim in mind to predict coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events.
Measured: 4 months
Linguistic Features via Linguistic Inquiry Word Count (LIWC)
LIWC-derived linguistic analysis of emotional tone taken from from expressively written text following a writing task prompt
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start20 Nov 2020
- Primary completion10 Jun 2021
- Study completion10 Jun 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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noom Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645108
- Sponsor's protocol ID
- 00046922
- Status last verified
- Oct 2022
- First submitted
- 28 Oct 2020
- Last updated
- 7 Oct 2022
- Results posted
- 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 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel Trial of Overweight Men and Women Using a Coached or Non-Coached Weight Loss Intervention
- ClinicalTrials.gov ID
- NCT04645108
- Acronym / sponsor ID
- 00046922
- Conditions
- Obesity, Behavior, Health, Behavior, Eating, Weight Loss, Overweight and Obesity, Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 27 Nov 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.
To evaluate the effect of one-on-one coaching in the Noom Healthy Weight Program, a digital behavior change, weight loss intervention, compared to the same program with no coaching, as well as influential factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coached | Experimental | Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching |
| No Coach | Active comparator | Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and provide informed consent
- 18-65 years old
- Self-report of good health (physical and mental)
- Not diagnosed with diabetes
- Overweight or obesity (BMI ≥ 27)
Key exclusion criteria (3 listed)
- Inability or unwillingness of a participant to give written informed consent
- Currently pregnant or ≤ 6 months postpartum
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the quality of the data E.g., evidence of an eating disorder, major chronic condition
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 with 1:1 coachingThe intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach. Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily. | Behavioural | Coached |
| Noom Healthy Weight; mobile behavior change program for weight lossThe intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity. During the first week of the study, participants will be introduced to the program, and the Noom app. | Behavioural | No Coach |
Primary outcome
Weight
Time frame: 4 months
Self reported
Self reported in app engagement measures
Time frame: 4 months
self reported and automatically logged
5 secondary outcomes
Quality of Life Via SF-12
Time frame: 4 months
Eating Behavior via the Dutch Eating Behavior Questionnaire
Time frame: 4 months
Resilience via Devereux Adult Resilience Survey
Time frame: 4 months
Self Efficacy via General Self-Efficacy Scale
Time frame: 4 months
Linguistic Features via Linguistic Inquiry Word Count (LIWC)
Time frame: 16 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 7 Oct 2022.
- 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.
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 Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching and 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 8 inclusion and 3 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 7 Oct 2022. 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?
Weight (time frame: 4 months). The study lists 2 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 7 Oct 2022.