Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

NCT04753268 | Completed

• 1 other identifier: 00048814
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Behavior, Health

Outcome Measures

Primary Outcomes (4)

• Weight

  Self-reported weight

  baseline to 6 months

• Program engagement

  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

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

  weeks 1-26

• Program satisfaction

  Satisfaction assessed via an in-house survey

  week 1 - 26 week

Study Arms (1)

Treatment group: Noom Healthy Weight Program

EXPERIMENTAL

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

Interventions

Noom Healthy Weight Program 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.

Treatment group: Noom Healthy Weight Program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female survivors of breast cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and provide informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Noom Inc.: lead

Study Sites (1)

Noom, Inc

New York, New York, 10001, United States

Location

Related Publications (1)

• 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.

  PMID: 38951532 DERIVED

MeSH Terms

Conditions

Weight Loss; Health Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 15, 2021
• Study Start: March 24, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)