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Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04753268
Recruitment Status : Completed
First Posted : February 15, 2021
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Noom Inc.

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
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 : March 24, 2021
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Weight [ Time Frame: baseline to 6 months ]
    Self-reported weight

  2. 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

  3. Program retention [ Time Frame: weeks 1-26 ]
    i.e. % = (total participants - number of drop out) / Total number of participants) * 100%

  4. Program satisfaction [ Time Frame: week 1 - 26 week ]
    Satisfaction assessed via an in-house survey


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female survivors of breast cancer
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753268


Locations
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United States, New York
Noom, Inc
New York, New York, United States, 10001
Sponsors and Collaborators
Noom Inc.
More Information
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Responsible Party: Noom Inc.
ClinicalTrials.gov Identifier: NCT04753268    
Other Study ID Numbers: 00048814
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes