Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 10:54 PM
Study NCT ID:
NCT05225350
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2020-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Meals on Prescription- a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible children where randomized to 1 of 2 interventional arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from Baseline in Dietary habits at one year', 'timeFrame': '1 year', 'description': 'Assessment of meal pattern and dietary composition through questionaire.'}, {'measure': 'Changes from Baseline in BMI at 3 months', 'timeFrame': '3 months', 'description': 'Changes in BMI SDS in the different intervention groups'}, {'measure': 'Changes from Baseline in BMI at 12 months', 'timeFrame': '12 months', 'description': 'Changes in BMI SDS in the different intervention groups'}, {'measure': 'Changes from Baseline in BMI at 18 months', 'timeFrame': '18 months', 'description': 'Changes in BMI SDS in the different intervention groups'}, {'measure': 'Changes from Baseline in BMI at 24 months', 'timeFrame': '24 months', 'description': 'Changes in BMI SDS in the different intervention groups'}], 'secondaryOutcomes': [{'measure': 'Changes from Baseline in metabolic parameters at 12 months', 'timeFrame': '12 months after treatment intervention', 'description': 'Glucose control (fP-Glc, fs-Insulin, HbA1c,), Blood lipids (HDL, LDL, TG,), (liver function tests (, ALT, ) Vitamin D'}, {'measure': 'Experience of intervention with in 1 year after intervention', 'timeFrame': 'with in 1 year after intervention', 'description': 'Qualitative investigation through interviews and analysis from statements in medical journal'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood', 'Hypertension', 'Metabolic Syndrome', 'Dietary Habits']}, 'referencesModule': {'references': [{'pmid': '40413511', 'type': 'DERIVED', 'citation': 'Torstensson T, Almqvist-Tangen G, Waters S, Kindblom JM, Roswall J, Chaplin JE, Sjogren L. "The big win was that we actually cooked"- a qualitative interview study about the parental experience of Family Meals on Prescription for children living with obesity. J Health Popul Nutr. 2025 May 24;44(1):171. doi: 10.1186/s41043-025-00921-3.'}, {'pmid': '39251447', 'type': 'DERIVED', 'citation': 'Torstensson T, Bohlin A, Almqvist-Tangen G, Roswall J, Kindblom JM, Sjogren L. Family meals on prescription as treatment for childhood obesity-a randomized controlled trial. Eur J Pediatr. 2024 Nov;183(11):4857-4866. doi: 10.1007/s00431-024-05744-8. Epub 2024 Sep 9.'}]}, 'descriptionModule': {'briefSummary': '"Matkassen - effekten av tre månaders intensiv kostintervention hos barn med fetma/ Family Meals on Prescription.- a randomized controlled trial : The aim of the study was to explore a novel approach for the treatment of obesity in children and adolescents through an intensive dietary intervention, consisting of receiving a weekly bag of groceries and recipes for five family meals at a reduced price for three months.\n\nData concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients\' one year follow up appointment at the clinics.', 'detailedDescription': "Children between the age of 5-15 years receiving treatment for obesity at the pediatric clinics in Varberg and Kungsbacka were offered to participate in the trial.\n\nThe study population was divided into two arms including 60 patients in each arm:\n\n* In the first arm the patients received care consistent with regional guidelines.\n* In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months.\n\nData concerning dietary patterns and food habits, weight, BMI and blood markers for metabolic and cardiovascular disease was collected before the study began and again at the end of the study during the patients' one year follow up appointment at the clinics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between the ages of 5 to 15\n* attending the Paediatric Obesity Clinics in Kungsbacka or Varberg\n\nExclusion Criteria:\n\n* Younger than 5 or older than 15'}, 'identificationModule': {'nctId': 'NCT05225350', 'briefTitle': 'Family Meals on Prescription- a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Matkassen-effekter av 3 månaders Intensiv Kostintervention Riktad Till Barn Med Fetma / Family Meals on Prescription- a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '19002468'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Controls', 'description': 'In the first arm the patients received care consistent with regional guidelines. Treatment as usual.'}, {'type': 'EXPERIMENTAL', 'label': 'Dietary Intervention', 'description': 'In the second arm the patients received care consistent with regional guidelines in combination with the intensive dietary intervention for three months', 'interventionNames': ['Behavioral: Dietary Intervention']}], 'interventions': [{'name': 'Dietary Intervention', 'type': 'BEHAVIORAL', 'description': 'See previous text\n\nDietary intervention consisiting och each family recieving foodpackages for 5 dinner meals during three months.', 'armGroupLabels': ['Dietary Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30233', 'city': 'Halmstad', 'state': 'Halland County', 'country': 'Sweden', 'facility': 'Pediatric Clinic Region Halland', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}], 'overallOfficials': [{'name': 'Lovisa Sjogren, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Goteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Halland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}