Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04353258
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research Intervention to Support Healthy Eating and Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-17'}], 'estimatedResultsFirstSubmitDate': '2025-12-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017216', 'term': 'Telemedicine'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2020-04-16', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'Baseline, 2 month, 6 month, 12 month, 18 months', 'description': 'Weight change measured on a digital scale to the nearest 0.1-kilogram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['weight loss, low income, behavioral economics, contingency management, episodic future thinking, mHealth'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The primary aim of this study is to test the efficacy of a behavioral economics intervention for weight loss in adults from economically disadvantaged backgrounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-75\n* BMI between 25-55kg/m2\n* All sexes\n* All racial/ethnic groups\n* Low SES and/or report qualifying for federal, state or local benefits\n* Have a smartphone and willing to use for research purposes\n\nExclusion Criteria:\n\n* \\<18-75\\>years of age\n* Report being unable to walk 2 blocks without stopping\n* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months\n* Are pregnant or plan to become pregnant within 1 year\n* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire\n* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines\n* Have diabetes and are on insulin\n* Report a medical condition that could jeopardize their safety in a weight loss program with diet and exercise guidelines\n* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)\n* Report unable to read and write English'}, 'identificationModule': {'nctId': 'NCT04353258', 'acronym': 'RISE', 'briefTitle': 'Research Intervention to Support Healthy Eating and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'Using Behavioral Economic Strategies to Address Obesity in Economically Disadvantaged Adults', 'orgStudyIdInfo': {'id': 'H19-141'}, 'secondaryIdInfos': [{'id': '1R01DK118957', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK118957', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Economics intervention (BE mHealth)', 'description': 'Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.', 'interventionNames': ['Behavioral: Behavioral Economics intervention (BE mHealth)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard mHealth intervention (mHealth)', 'description': 'Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).', 'interventionNames': ['Behavioral: Standard mHealth intervention (mHealth)']}], 'interventions': [{'name': 'Behavioral Economics intervention (BE mHealth)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.', 'armGroupLabels': ['Behavioral Economics intervention (BE mHealth)']}, {'name': 'Standard mHealth intervention (mHealth)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).', 'armGroupLabels': ['Standard mHealth intervention (mHealth)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06103', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Weight Management Research Lab', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}], 'overallOfficials': [{'name': 'Tricia Leahey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Connecticut'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tricia Leahey', 'investigatorAffiliation': 'University of Connecticut'}}}}