Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

• Sponsor: Noom Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04753268
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss; Behavior, Health	Behavioral: Noom Healthy Weight Program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.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)
• Primary Purpose: Health Services Research
• Official Title: Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
• Actual Study Start Date: Mar 24, 2021
• Actual Primary Completion Date: Oct 1, 2021
• Actual Study Completion Date: Oct 1, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Treatment group: 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.

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.

Outcome Measures

Primary Outcome Measures

1. Weight [baseline to 6 months]

   Self-reported weight

2. Program engagement [weeks 1-26]

   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

3. Program retention [weeks 1-26]

   i.e. % = (total participants - number of drop out) / Total number of participants) * 100%

4. Program satisfaction [week 1 - 26 week]

   Satisfaction assessed via an in-house survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Noom, Inc	New York	New York	United States	10001

Sponsors and Collaborators

• Noom Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noom Inc.
• ClinicalTrials.gov Identifier: NCT04753268
• Other Study ID Numbers: 00048814
• First Posted: Feb 15, 2021
• Last Update Posted: Nov 18, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

No Results Posted as of Nov 18, 2021