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Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04753268
Enrollment
30
Registered
2021-02-15
Start date
2021-03-24
Completion date
2021-10-01
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Health, Weight Loss

Brief 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.

Interventions

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.

Sponsors

Noom Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Weightbaseline to 6 monthsSelf-reported weight
Program engagementweeks 1-26Engagement 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 retentionweeks 1-26i.e. % = (total participants - number of drop out) / Total number of participants) \* 100%
Program satisfactionweek 1 - 26 weekSatisfaction assessed via an in-house survey

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026