Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:09 AM
Study NCT ID:
NCT07419503
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-19
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
010Fit'R - Healthy Lifestyle Interventions for Children With Overweight
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'No control group intervention trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Demographic variables - assessed by a questionnaire', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'Age, gender, living situation, country of birth, income and education level of parents'}, {'measure': 'Feasibility data on implementation outcomes', 'timeFrame': 'At the end of an intervention (depending on intervention at 12 to 40 weeks)', 'description': 'Feasibility data on implementation outcomes (e.g. reach, adoption, implementation, sustainability) will be collected through questionnaires for parents, focus groups with children and parents, administrative data and interviews with providers'}], 'primaryOutcomes': [{'measure': 'PROMIS - assessed by a questionnaire', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'Health-related quality of life measured by the Patient-Reported Outcomes Measurement Information System'}], 'secondaryOutcomes': [{'measure': 'BMI - assessed by physical measurement', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'Based on height and weight'}, {'measure': 'Motor skills - assessed by physical measurement', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': '4 S-en test (Kernebeek et al., 2018)'}, {'measure': 'Nutrition - assessed by a questionnaire', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'Frequency of eating breakfast, fruit, vegetables, whole grain producents, sweet beverages, snacks'}, {'measure': 'Physical activity - assessed by a questionnaire', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'Frequency and duration of playing sports, playing outside, perception of physical behaviour'}, {'measure': 'Sleep behaviour - assessed by a questionnaire', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'General duration of sleep (hours) and sleep behaviour in the past 2 months'}, {'measure': 'Screen time - assessed by a questionnaire', 'timeFrame': 'Pre- and post intervention - from enrollment to the end of intervention (depending on intervention at 12 to 40 weeks)', 'description': 'General duration of screen time (hours) on weekdays and during weekends'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'children', 'lifestyle intervention'], 'conditions': ['Overweight', 'Children']}, 'descriptionModule': {'briefSummary': 'Overweight is a leading risk factor for non-communicable diseases. In the Netherlands, about 11% of children aged 4-12 years are overweight. The causes of childhood overweight are multifaceted, involving (epi)genetic, environmental, socioeconomic, and behavioral factors. The societal consequences are far-reaching, including lower academic performance, reduced quality of life and a greater risk of developing obesity in adulthood.\n\nLifestyle interventions with diet and physical activity components have been shown to effectively reduce childhood overweight. The "010 Fit\'R - Rotterdam approach for children with overweight" targets children between 4 and 12 years old and their parents. The program consists of multicomponent interventions addressing various lifestyle aspects, such as physical activity, nutrition, motor skills and healthy behaviours aiming to foster sustainable lifestyle changes. Providers were invited by the municipality of Rotterdam to develop interventions within the policy framework of 010 Fit\'R. 12 providers were selected by the municipality based on the selection criteria (quality of the program; experience with the activities and target group; demonstrable connection with the area; connection with the target group; recruitment strategy; costs) and distributed over different neighbourhoods. This study evaluates the healthy lifestyle interventions involved in 010 Fit\'R in terms of effectiveness and implementation outcomes.\n\nQuantitative data includes self-reported questionnaires, administrative data, a motor skill performance assessment and height and weight measurements to determine Body Mass Index (BMI). Data will be collected through self-reported questionnaires filled in by the parents of children who participate in 010 Fit\'R. Additionally, children will be assessed on motor skills by providers of healthy lifestyle interventions involved in 010 Fit\'R. Moreover, weight and height will be measured by the provider following standardized procedures. The parental questionnaire, motor skills and BMI will be assessed pre and post intervention. Administrative data includes data reported by providers on implementation outcomes, for example, data regarding enrolment and retention.\n\nQualitative data includes documentary evidence of each healthy lifestyle intervention involved in 010 Fit\'R to assess \'effective components\' of interventions. In addition, two workshops with providers and/or practitioners of interventions will be held to map the context, working elements and outcomes.\n\nFocus groups (FGs) and semi-structured interviews are used to gather information from parents, children and providers and/or practitioners regarding implementation outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Providers of the interventions will recruite children (4-12 years old) with overweight to participate in their intervention. All children (and their parents) participating in the interventions are invited to participate in the evaluation research study.\n\nInclusion Criteria:\n\n* Child participates in the 010Fit'R program and is between 4 and 12 years old (at the start of recruitment)\n* Parents of children participating in the 010 Fit'R program\n* Provider (e.g. participate in interview) is actively involved in promoting, implementing or conducting a healthy lifestyle intervention funded by 010Fit'R\n\nAll participants should be able to comprehend provided information to make an informed decision for participation and should provide consent for participating. In case of children the parent(s) consent, as well as the child when 12 years old.\n\nExclusion Criteria:\n\n* Outside of the age range, no consent for participation from provider, parent and/or child"}, 'identificationModule': {'nctId': 'NCT07419503', 'acronym': "010Fit'R", 'briefTitle': "010Fit'R - Healthy Lifestyle Interventions for Children With Overweight", 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': "010 Fit'R 2025-2027: Approach for Children (4-12 Years Old) With Overweight", 'orgStudyIdInfo': {'id': '13555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention', 'description': 'Children (4-12 years old) participate in one of 12 healthy lifestyle interventions focused on physical activity, nutrition and additional lifestyle factors', 'interventionNames': ["Behavioral: 010 Fit'R intervention"]}], 'interventions': [{'name': "010 Fit'R intervention", 'type': 'BEHAVIORAL', 'description': "Within the policy framework of 010 Fit'R, 12 different healthy lifestyle interventions will be implemented for children with overweight. Children participate in one of the 12 interventions. All interventions consist of at least one physical activity each week and encouraging a healthy lifestyle in children, individually or in groups, and advising children and their parents on nutrition, exercise, motor skills, and sustainable behavioral change.", 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Department of Public Health, Erasmus MC University Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A data sharing statement will be finalized when known which percentage of participants consent for sharing data outside of our own organization.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior researcher', 'investigatorFullName': 'Wilma Jansen', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}