Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Weight Loss; Behavior, Health
• Interventions: Behavioral: Noom Healthy Weight Program

• Registration Number: NCT04753268
• Lead Sponsor: Noom Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-03-24
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group: Noom Healthy Weight Program	Noom Healthy Weight 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.

Primary Outcome Measures

Name	Time	Method
Program satisfaction	week 1 - 26 week	Satisfaction assessed via an in-house survey
Program engagement	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
Weight	baseline to 6 months	Self-reported weight
Program retention	weeks 1-26	i.e. % = (total participants - number of drop out) / Total number of participants) \* 100%

Trial Locations

Locations (1)

Noom, Inc; 🇺🇸 New York, New York, United States