Weight LossNCT04753268
Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
A study testing Noom Healthy Weight Program in people with Weight Loss and Behavior, Health, run by Noom Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the preliminary efficacy of a Noom Breast Cancer Weight Loss Program on weight loss outcomes, quality of life, and physical activity. Also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Behavior, Health
- What is being tested?
- Noom Healthy Weight Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 1 Oct 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand and provide informed consent
- 18 years and older
- Overweight or obesity (BMI ≥ 27.5)
- Not 6 months postpartum
- Not planning to become pregnant in the next 7 months
- Have a smartphone that is compatible with Noom's mobile app
- Breast cancer survivor with stage I, II, or III
- Completed active treatment (e.g, surgery, chemo, radiation, etc.) > 6 months ago
Who cannot join
- Inability or unwillingness of a participant to give written informed consent
- Currently pregnant or < 6 months postpartum
- Plans to become pregnant within the next 7 months
- Stage IV, metastatic cancer or DCIS
- Currently taking insulin
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
The purpose of this study is to evaluate the preliminary efficacy of a Noom Breast Cancer Weight Loss Program on weight loss outcomes, quality of life, and physical activity. Also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity.
- Conditions
- Weight Loss, Behavior, Health
- Being tested
- Noom Healthy Weight Program
- Medical subject headings
- Weight Loss, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noom Healthy Weight ProgramBehavioural
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, physical activity, and meals daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: Noom Healthy Weight Program | Experimental | 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. Receives: Behavioral: Noom Healthy Weight Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Self-reported weight
Measured: baseline to 6 months
Program engagement
Engagement with the Noom program; measured as
- Number of App opens
- Messages to coach
- Number of Steps
- Logged food
- Logged exercise
- Group messages and likes
- Articles read
Measured: weeks 1-26
Program retention
i.e. % = (total participants - number of drop out) / Total number of participants) * 100%
Measured: weeks 1-26
Program satisfaction
Satisfaction assessed via an in-house survey
Measured: week 1 - 26 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start24 Mar 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm pilot study evaluating preliminary efficacy and acceptability of a Noom breast cancer survivor weight loss program. 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, physical activity, and meals daily.
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT04753268
- Sponsor's protocol ID
- 00048814
- Status last verified
- Oct 2022
- First submitted
- 29 Jan 2021
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen S, Salehi E, White C, Chen Y, Iyengar NM. Evaluation of a mobile behavior change program for weight loss in breast cancer survivors. NPJ Breast Cancer. 2024 Jun 29;10(1):53. doi: 10.1038/s41523-024-00659-x.
PubMed 38951532
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT04753268
- Acronym / sponsor ID
- 00048814
- Conditions
- Weight Loss, Behavior, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Noom Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 15 Feb 2021 (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 purpose of this study is to evaluate the preliminary efficacy of a Noom Breast Cancer Weight Loss Program on weight loss outcomes, quality of life, and physical activity. Also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm pilot study evaluating preliminary efficacy and acceptability of a Noom breast cancer survivor weight loss program. 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, physical activity, and meals daily.
| Arm | Type | Receives |
|---|---|---|
| Treatment group: Noom Healthy Weight Program | Experimental | Behavioral: Noom Healthy Weight ProgramThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to understand and provide informed consent
- 18 years and older
- Overweight or obesity (BMI ≥ 27.5)
- Not 6 months postpartum
- Not planning to become pregnant in the next 7 months
Key exclusion criteria (6 listed)
- Inability or unwillingness of a participant to give written informed consent
- Currently pregnant or < 6 months postpartum
- Plans to become pregnant within the next 7 months
- Stage IV, metastatic cancer or DCIS
- Currently taking insulin
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 ProgramThe 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, physical activity, and meals daily. | Behavioural | Treatment group: Noom Healthy Weight Program |
Primary outcome
Weight
Time frame: baseline to 6 months
Self-reported weight
Program engagement
Time frame: weeks 1-26
Engagement with the Noom program; measured as 1. Number of App opens 2. Messages to coach 3. Number of Steps 4. Logged food 5. Logged exercise 6. Group messages and likes 7. Articles read
Program retention
Time frame: weeks 1-26
i.e. % = (total participants - number of drop out) / Total number of participants) * 100%
Program satisfaction
Time frame: week 1 - 26 week
Satisfaction assessed via an in-house survey
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 6 Oct 2022.
- Derived from this study: PubMed 38951532Shen S, Salehi E, White C, Chen Y, Iyengar NM. Evaluation of a mobile behavior change program for weight loss in breast cancer survivors. NPJ Breast Cancer. 2024 Jun 29;10(1):53. doi: 10.1038/s41523-024-00659-x.
- 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 Program in people with Weight Loss 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 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 6 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: baseline to 6 months). 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?
On the ClinicalTrials.gov record for NCT04753268, which also lists 1 linked publication.
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 6 Oct 2022.