Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

October 5, 2022 updated by: Noom Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Noom, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noom Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 24, 2021

Primary Completion (ACTUAL)

October 1, 2021

Study Completion (ACTUAL)

October 1, 2021

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00048814

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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