Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753268
• Other study ID #: 00048814
• Status: Completed
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2022
• Source: Noom Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Health
• Body Weight
• Weight Loss

Intervention

Behavioral:
• 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. 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.

Locations

Country	Name	City	State
United States	Noom, Inc	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Noom Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Self-reported weight	baseline to 6 months
Primary	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
Primary	Program retention	i.e. % = (total participants - number of drop out) / Total number of participants) * 100%	weeks 1-26
Primary	Program satisfaction	Satisfaction assessed via an in-house survey	week 1 - 26 week