Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

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

Conditions
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Weight Loss, Behavior, Health

Intervention / Treatment
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* Behavioral: Noom Healthy Weight Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group: Noom Healthy Weight Program<br>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. | Behavioral: Noom Healthy Weight Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Self-reported weight | 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 | weeks 1-26 | 
| Program retention | i.e. % = (total participants - number of drop out) / Total number of participants) * 100% | weeks 1-26 | 
| Program satisfaction | Satisfaction assessed via an in-house survey | week 1 - 26 week |