Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

NCT ID: NCT04753268

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-24

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss Behavior, Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Noom Healthy Weight Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Noom Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Noom, Inc

New York, New York, United States

Site Status

Countries

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United States

References

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Shen S, Salehi E, White C, Chen Y, Iyengar NM. Evaluation of a mobile behavior change program for weight loss in breast cancer survivors. NPJ Breast Cancer. 2024 Jun 29;10(1):53. doi: 10.1038/s41523-024-00659-x.

Reference Type DERIVED
PMID: 38951532 (View on PubMed)

Other Identifiers

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00048814

Identifier Type: -

Identifier Source: org_study_id

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