Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-03-05 @ 5:59 AM
Study NCT ID:
NCT02223234
Status:
COMPLETED
Last Update Posted:
2017-01-04
First Post:
2014-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guelph Family Health Study: Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-03', 'studyFirstSubmitDate': '2014-08-20', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in adiposity', 'timeFrame': 'baseline, 6 month follow-up'}], 'secondaryOutcomes': [{'measure': 'change in body mass index', 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': 'change in waist circumference', 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': 'change in frequency of family meals', 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': "change in child's sleep duration", 'timeFrame': 'baseline, 6-months'}, {'measure': "change in child's physical activity", 'timeFrame': 'baseline, 6-months'}, {'measure': "change in child's fruit and vegetable intake", 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': "change in child's sugar-sweetened beverage intake", 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': 'change in sedentary behaviour', 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': "change in child's diastolic blood pressure", 'timeFrame': 'baseline, 6-month follow-up'}, {'measure': "change in child's biomarkers of diabetes and cardiovascular disease risk", 'timeFrame': 'baseline, 6-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '30873285', 'type': 'DERIVED', 'citation': 'Krystia O, Ambrose T, Darlington G, Ma DWL, Buchholz AC, Haines J; Guelph Family Health Study. A randomized home-based childhood obesity prevention pilot intervention has favourable effects on parental body composition: preliminary evidence from the Guelph Family Health Study. BMC Obes. 2019 Mar 4;6:10. doi: 10.1186/s40608-019-0231-y. eCollection 2019.'}, {'pmid': '29981086', 'type': 'DERIVED', 'citation': "Haines J, Douglas S, Mirotta JA, O'Kane C, Breau R, Walton K, Krystia O, Chamoun E, Annis A, Darlington GA, Buchholz AC, Duncan AM, Vallis LA, Spriet LL, Mutch DM, Brauer P, Allen-Vercoe E, Taveras EM, Ma DWL; Guelph Family Health Study. Guelph Family Health Study: pilot study of a home-based obesity prevention intervention. Can J Public Health. 2018 Aug;109(4):549-560. doi: 10.17269/s41997-018-0072-3. Epub 2018 Apr 25."}]}, 'descriptionModule': {'briefSummary': "The overall objective of the proposed study is to test, among Canadian families, the comparative effectiveness of 2 different versions (doses) of a family-based obesity prevention intervention that is tailored to families' behavioural risk profile.\n\nTo achieve this objective, we will conduct a randomized controlled trial of families with children aged 18 months- 5 years. Families will be randomized to 1 of 3 conditions: 1) Monthly emails with general health information (Attention Control), 2) Tailored weekly emails and 2 home visits with a health educator (Email +2), 3) Tailored weekly emails and 4 home visits (Email +4). The intervention will last 6 months, with follow-up at 12-months post-intervention (18 months from baseline). We will examine the impact of the intervention on the children's body composition, weight-related behaviours, and biomarkers of diabetes and cardiovascular disease risk.\n\nWe hypothesize that, compared to children in the Attention Control, children in the Email +2 and Email +4 conditions will achieve:\n\n1. a smaller increase in adiposity (primary outcome), age- and gender-specific body mass index (BMI),over a 6-month intervention period.\n2. higher frequency of family meals, child's sleep duration, physical activity, and fruit and vegetable intake and lower child's sugar-sweetened beverage intake, and sedentary behaviour over a 6-month intervention period. (secondary outcomes)\n3. lower diastolic blood pressure, glycosylated hemoglobin, fasting glucose, fasting insulin, Low Density Lipoprotein (LDL) cholesterol, triglycerides, C-reactive protein, trans and saturated fats, and higher High Density Lipoprotein (HDL) cholesterol over a 6-month intervention period.\n\nWe further hypothesize that there will be no significant difference in these outcomes between children in the conditions with 2 (Email +2) or 4 (Email +4) home visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* families who have a child aged 18 months through 5 years\n* live the Guelph area\n* have a parent who can respond to questionnaires in English\n\nExclusion Criteria:\n\n* families who plan to move during the study period\n* children with severe health conditions (such as severe cerebral palsy) that would prohibit them from participating in study activities'}, 'identificationModule': {'nctId': 'NCT02223234', 'briefTitle': 'Guelph Family Health Study: Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'Guelph Family Health Study: Pilot Study', 'orgStudyIdInfo': {'id': '14AP008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "Control- monthly mailed information on children's health", 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Email and 4 Home Visits', 'description': 'Weekly emails and 4 home visits with a health educator', 'interventionNames': ['Behavioral: Emails and 4 Home Visits']}, {'type': 'EXPERIMENTAL', 'label': 'Email and 2 Home Visits', 'description': 'Weekly emails and 2 home visits', 'interventionNames': ['Behavioral: Emails and 2 home visits']}], 'interventions': [{'name': 'Emails and 4 Home Visits', 'type': 'BEHAVIORAL', 'description': 'Weekly emails and 4 home visits with health educator', 'armGroupLabels': ['Email and 4 Home Visits']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Monthly emails on child health', 'armGroupLabels': ['Control']}, {'name': 'Emails and 2 home visits', 'type': 'BEHAVIORAL', 'description': 'Weekly emails and 2 home visits with health educator', 'armGroupLabels': ['Email and 2 Home Visits']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G 2W1', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univeristy of Guelph', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jess Haines', 'investigatorAffiliation': 'University of Guelph'}}}}