Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-17 @ 5:16 AM
Study NCT ID:
NCT06547320
Status:
COMPLETED
Last Update Posted:
2025-10-20
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total energy intake', 'timeFrame': 'Daily average computed for the 7-day observation period and each 7-day intervention period', 'description': 'Total amount of energy consumed from foods and beverages'}], 'secondaryOutcomes': [{'measure': 'Energy intake per eating occasion', 'timeFrame': 'Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period', 'description': 'Amount of energy consumed from foods and beverages during each eating occasion'}, {'measure': 'Rate of eating per eating occasion', 'timeFrame': 'Average intake per eating occasion computed for the 7-day observation period and each 7-day intervention period', 'description': 'Chews per minute during each eating occasion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a sensor device called an Automatic Ingestion Monitor (AIM) that is worn on eyeglasses can be used with a smartphone to change eating behavior. Participants will wear the device for one week of no-intervention observation. They will then test behavioral interventions focused on eating for two weeks. The researchers hypothesize that messages sent to a smartphone that are based on information from the AIM can reduce the amount of food that is eaten and slow eating.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 27 and 45 kg/m-squared\n* Weight stable within 5% in the past 6 months\n* Self-reports basic familiarity with use of a smartphone\n\nExclusion Criteria:\n\n* Diagnosed diabetes (type 1 and 2)\n* Any poorly controlled medical condition that could affect weight and/or eating behavior (e.g., hypothyroidism)\n* Medical conditions or use of medications or diets/supplements known to affect energy regulation or appetite\n* Difficulty chewing or swallowing\n* Diagnosed eating disorder\n* Night or shift work\n* Current participation in a weight loss program\n* History of bariatric surgery\n* Current pregnancy or lactation within the past 1 year, or planning a pregnancy during the study participation period\n* Consuming a medically-prescribed or unusual diet (e.g., macrobiotic)\n* Food allergies or sensitivities, or other conditions which result in avoidance of a wide range of foods (e.g. celiac disease, tree nut allergy)\n* Reported recreational drug use\n* Report of conditions that would significantly interfere with an ability to follow the protocol including terminal illness, substance abuse, or other significant uncontrolled psychiatric problem'}, 'identificationModule': {'nctId': 'NCT06547320', 'briefTitle': 'Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'Sensor-based Just-in Time Adaptive Interventions (JITAIs) Targeting Eating Behavior', 'orgStudyIdInfo': {'id': 'R01DK122473', 'link': 'https://reporter.nih.gov/quickSearch/R01DK122473', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Just-in-time Adaptive Intervention', 'description': 'A sensor device called an Automatic Ingestion Monitor (AIM) will be worn on eyeglasses to monitor eating. Information from the device will be used to send messages to a smartphone to change eating behavior.', 'interventionNames': ['Behavioral: Eat Less Intervention', 'Behavioral: Eat Slower Intervention']}], 'interventions': [{'name': 'Eat Less Intervention', 'type': 'BEHAVIORAL', 'description': 'A sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the amount of food eaten.', 'armGroupLabels': ['Just-in-time Adaptive Intervention']}, {'name': 'Eat Slower Intervention', 'type': 'BEHAVIORAL', 'description': 'A sensor worn on eyeglasses monitors eating and provides messages to a smartphone when eating occurs to prompt small reductions in the rate of eating.', 'armGroupLabels': ['Just-in-time Adaptive Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital Weight Control and Diabetes Resarch Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': 'We will make data and documentation available under a data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.', 'accessCriteria': 'A data-sharing agreement that provides for (1) a commitment to use the data for research purposes only; (2) a commitment to securing the data using appropriate computer technology; (3) a commitment to destroying or returning the data after analyses are completed and (4) a commitment not to attempt to identify participants individually. Information shared with outside collaborators will link personal health information to a unique study ID in order to maintain participant anonymity.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}