Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
Study NCT ID:
NCT04436692
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2020-06-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dietary Intervention and Adults With Intellectual Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-17', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in consumption of sugar containing beverages as measured using dietary survey', 'timeFrame': 'One year', 'description': 'Dietary change 2'}], 'primaryOutcomes': [{'measure': 'Change in body weight by using a nudging approach in adults with intellectual disabilities', 'timeFrame': 'One year', 'description': '2 kg weight decrease'}], 'secondaryOutcomes': [{'measure': 'Change in consumption of fruits and vegetables as measured using dietary survey', 'timeFrame': 'One year', 'description': 'Dietary change 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intellectual Disabilities Nutritional', 'Intellectual Disability']}, 'descriptionModule': {'briefSummary': 'Goal The overall aim of the study is to improve the health of persons with Intellectual disabilities', 'detailedDescription': 'Purpose\n\nThere are two main purposes of the study The first is to study the diet and heath of persons with intellectual disabilities. The second is to increase their knowledge on nutrition and health and that of service providers in municipalities housing facilities and to test, in an intervention, the effects of a method for weight reduction in adult persons with intellectual disabilities with overweight and obesity. Physical activity is also an important factor in weight reduction, but this study focuses only on nutrition, to obtain new information on this one factor in weight reduction. A combined study with many changes in a short period of time is very challenging for the group in question.\n\nThe vision is that results from this study will lead to improved health promotive and preventive services in the municipality in the future, to adult persons with intellectual disabilities and that this study also can have effects on services also for other groups, such as those with the fields of psychiatry and drug problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Mild intellectual disability and overweight\n* Moderate intellectual disability and overweight\n\nExclusion Criteria:\n\n* Metabolic diseases\n* Hypertension\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT04436692', 'briefTitle': 'Dietary Intervention and Adults With Intellectual Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method', 'orgStudyIdInfo': {'id': 'Department of Nutrition'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Improve dietary pattern', 'description': 'Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight', 'interventionNames': ['Behavioral: Nudging']}], 'interventions': [{'name': 'Nudging', 'type': 'BEHAVIORAL', 'description': 'Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables', 'armGroupLabels': ['Improve dietary pattern']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Lene F Andersen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Basic Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Svein Olav Kolset', 'investigatorAffiliation': 'University of Oslo'}}}}