Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
Primary Purpose
Weight Loss, Behavior, Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Noom Healthy Weight Program
Sponsored by

About this trial
This is an interventional health services research trial for Weight Loss
Eligibility Criteria
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
Sites / Locations
- Noom, Inc
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment group: Noom Healthy Weight Program
Arm Description
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.
Outcomes
Primary Outcome Measures
Weight
Self-reported weight
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
Program retention
i.e. % = (total participants - number of drop out) / Total number of participants) * 100%
Program satisfaction
Satisfaction assessed via an in-house survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04753268
Brief Title
Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
Official Title
Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noom Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Behavior, Health
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group: Noom Healthy Weight Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Noom Healthy Weight Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight
Description
Self-reported weight
Time Frame
baseline to 6 months
Title
Program engagement
Description
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
Time Frame
weeks 1-26
Title
Program retention
Description
i.e. % = (total participants - number of drop out) / Total number of participants) * 100%
Time Frame
weeks 1-26
Title
Program satisfaction
Description
Satisfaction assessed via an in-house survey
Time Frame
week 1 - 26 week
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female survivors of breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Noom, Inc
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
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