Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-18 @ 10:34 AM
Study NCT ID:
NCT06348251
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2024-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FoodSteps for Binge Eating & Food Insecurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2025-12-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D006963', 'term': 'Hyperphagia'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-14', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-03-30', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment and retention rates', 'timeFrame': '16 weeks', 'description': 'Feasibility assessed by study recruitment and retention rates'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge Eating', 'Type 2 Diabetes', 'Food Insecurity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 18 years or older\n* Recurrent binge eating (≥12 episodes in the past 3 months)\n* Type 2 diabetes mellitus\n* Food insecure status (e.g. difficulty accessing food)\n* Interested in losing weight and reducing binge eating\n* Willing to use a mobile application\n* Has a smartphone with Internet access and capacity for calls and text messaging\n* Has a valid email address\n* Not pregnant\n* English-speaking\n\nExclusion Criteria:\n\n* Diagnosis for which the study/intervention is not clinically indicated\n* Currently receiving clinical services for weight management or binge eating\n* Started or recently (within the past month) changed dosage of a medication for binge eating, weight management, or diabetes'}, 'identificationModule': {'nctId': 'NCT06348251', 'briefTitle': 'FoodSteps for Binge Eating & Food Insecurity', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluating a Digital Intervention for Binge Eating and Weight Management Among Adults With Food Insecurity', 'orgStudyIdInfo': {'id': 'STU00219612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Behavioral intervention', 'interventionNames': ['Behavioral: FoodSteps']}], 'interventions': [{'name': 'FoodSteps', 'type': 'BEHAVIORAL', 'description': 'Participants will get access to the FoodSteps digital intervention with coaching for 16 weeks and receive a weekly stipend benefit to aid with implementing health behavior changes', 'armGroupLabels': ['Behavioral intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}