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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
Noom Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

First Posted
January 29, 2021
Last Updated
October 5, 2022
Sponsor
Noom Inc.
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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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