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OpenTrials
Completed

NCT Number: NCT04753268

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.

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Key information

Conditions

Weight Loss Behavior Behavior, Health Body Weight Body Weight Changes Health Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Noom, Inc

New York, 10001, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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

    • Number of App opens
    • Messages to coach
    • Number of Steps
    • Logged food
    • Logged exercise
    • Group messages and likes
    • 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

Sponsors and collaborators

Lead sponsor

Noom Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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