Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-26 @ 5:23 AM
Study NCT ID:
NCT06349460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002032', 'term': 'Bulimia'}, {'id': 'D009765', 'term': 'Obesity'}], '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': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'In this micro-randomized trial, participants will have 2 consecutive, independent micro-randomizations at the time of target selection each week for 16 weeks: namely, 1 of 5 treatment targets will be randomly delivered, either as a recommended or assigned target, to each user, of equal probability per randomization.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-03-30', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly change in binge eating', 'timeFrame': '1 week', 'description': 'Change in number of binge eating episodes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Binge Eating', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '40167045', 'type': 'DERIVED', 'citation': 'Ortega A, Rooper IR, Massion T, Azubuike C, Lipman LD, Lakhtakia T, Camino MK, Parsons LM, Tack E, Alshurafa N, Kay M, Graham AK. Co-designing prediction data visualizations for a digital binge eating intervention. Transl Behav Med. 2025 Jan 16;15(1):ibaf009. doi: 10.1093/tbm/ibaf009.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults age 18 years or older\n* Obesity (BMI ≥30)\n* Recurrent binge eating (≥12 episodes in the past 3 months)\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* Has access to a scale\n* Not pregnant\n* English-speaking\n\nExclusion Criteria:\n\n* Diagnosis for which the study/intervention is not clinically indicated\n* Not currently receiving clinical services for weight management or binge eating'}, 'identificationModule': {'nctId': 'NCT06349460', 'briefTitle': 'Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Micro-Randomized Trial to Optimize Just-in-Time Adaptive Intervention for Binge Eating & Weight-related Behaviors', 'orgStudyIdInfo': {'id': 'STU00216998'}, 'secondaryIdInfos': [{'id': 'R01DK133300', 'link': 'https://reporter.nih.gov/quickSearch/R01DK133300', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Increase healthy eating behaviors - Assigned', 'description': 'Individuals will be assigned to increase healthy eating behaviors that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Increase healthy eating behaviors - Recommended', 'description': 'Individuals will be recommend to increase healthy eating behaviors that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Increase physical activity - Assigned', 'description': 'Individuals will be assigned to increase physical activity that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Increase physical activity - Recommended', 'description': 'Individuals will be recommended to increase physical activity that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Limit unhealthy dieting behaviors - Assigned', 'description': 'Individuals will be assigned to limit unhealthy dieting behaviors that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Limit unhealthy dieting behaviors - Recommended', 'description': 'Individuals will be recommended to limit unhealthy dieting behaviors that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Improve self-image - Assigned', 'description': 'Individuals will be assigned to improve self-image that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Improve self-image - Recommended', 'description': 'Individuals will be recommended to improve self-image that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Improve mood - Assigned', 'description': 'Individuals will be assigned to improve mood that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Improve mood - Recommended', 'description': 'Individuals will be recommended to improve mood that week.', 'interventionNames': ['Behavioral: FoodSteps behavioral intervention']}], 'interventions': [{'name': 'FoodSteps behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Behavioral intervention that targets binge eating and weight-related behaviors. Each week, users are recommended or assigned one of five targets, set a relevant goal, and track their progress. If a target is recommended, the user can choose to select that target or a different target.', 'armGroupLabels': ['Improve mood - Assigned', 'Improve mood - Recommended', 'Improve self-image - Assigned', 'Improve self-image - Recommended', 'Increase healthy eating behaviors - Assigned', 'Increase healthy eating behaviors - Recommended', 'Increase physical activity - Assigned', 'Increase physical activity - Recommended', 'Limit unhealthy dieting behaviors - Assigned', 'Limit unhealthy dieting behaviors - Recommended']}]}, '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'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrea Graham', 'investigatorAffiliation': 'Northwestern University'}}}}