Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-01 @ 1:50 PM
Study NCT ID:
NCT04753268
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a prospective, single-arm pilot study evaluating preliminary efficacy and acceptability of a Noom breast cancer survivor weight loss program.\n\nThe 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.\n\nCoaches 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'baseline to 6 months', 'description': 'Self-reported weight'}, {'measure': 'Program engagement', 'timeFrame': 'weeks 1-26', 'description': 'Engagement with the Noom program; measured as\n\n1. Number of App opens\n2. Messages to coach\n3. Number of Steps\n4. Logged food\n5. Logged exercise\n6. Group messages and likes\n7. Articles read'}, {'measure': 'Program retention', 'timeFrame': 'weeks 1-26', 'description': 'i.e. % = (total participants - number of drop out) / Total number of participants) \\* 100%'}, {'measure': 'Program satisfaction', 'timeFrame': 'week 1 - 26 week', 'description': 'Satisfaction assessed via an in-house survey'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss', 'Behavior, Health']}, 'referencesModule': {'references': [{'pmid': '38951532', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female survivors of breast cancer', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to understand and provide informed consent\n* 18 years and older\n* Overweight or obesity (BMI ≥ 27.5)\n* Not 6 months postpartum\n* Not planning to become pregnant in the next 7 months\n* Have a smartphone that is compatible with Noom's mobile app\n* Breast cancer survivor with stage I, II, or III\n* Completed active treatment (e.g, surgery, chemo, radiation, etc.) \\> 6 months ago\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent\n* Currently pregnant or \\< 6 months postpartum\n* Plans to become pregnant within the next 7 months\n* Stage IV, metastatic cancer or DCIS\n* Currently taking insulin\n* Uncontrolled hypertension"}, 'identificationModule': {'nctId': 'NCT04753268', 'briefTitle': 'Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Noom Inc.'}, 'officialTitle': 'Preliminary Examination of a Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors', 'orgStudyIdInfo': {'id': '00048814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group: Noom Healthy Weight Program', 'description': '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.', 'interventionNames': ['Behavioral: Noom Healthy Weight Program']}], 'interventions': [{'name': 'Noom Healthy Weight Program', 'type': 'BEHAVIORAL', 'description': '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.\n\nCoaches 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.', 'armGroupLabels': ['Treatment group: Noom Healthy Weight Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10001', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Noom, Inc', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noom Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}