Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2025-12-28 @ 6:45 PM
Study NCT ID:
NCT03986632
Status:
UNKNOWN
Last Update Posted:
2019-06-14
First Post:
2019-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-12', 'studyFirstSubmitDate': '2019-06-02', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in age- and sex-specific BMI percentiles and z-scores', 'timeFrame': 'twice annually for 3 years'}, {'measure': 'Change in child intake of vegetables and fruit', 'timeFrame': 'twice annually for 3 years', 'description': '24-hour recall in combination with a 2-day food record'}, {'measure': 'Change in child intake of vegetables and fruit', 'timeFrame': 'twice annually for 3 years', 'description': 'Skin carotenoid meter using reflection spectroscopy (veggie-meter)'}, {'measure': 'Change in child intake of sugar sweetened beverages', 'timeFrame': 'twice annually for 3 years', 'description': 'Hair biomarker of sugar using N and C stable isotope ratios'}, {'measure': 'Change in child intake of sugar sweetened beverages', 'timeFrame': 'twice annually for 3 years', 'description': '24-hour recall in combination with a 2-day food record'}, {'measure': 'Change in child screen time', 'timeFrame': 'twice annually for 3 years', 'description': 'Screen time questionnaire'}, {'measure': 'Change in child physical activity', 'timeFrame': 'twice annually for 3 years', 'description': 'Physical activity questionnaire'}], 'secondaryOutcomes': [{'measure': 'Change in adult attitudes and beliefs around healthy eating and active lifestyle', 'timeFrame': 'twice annually for 3 years', 'description': 'Attitudes and beliefs questionnaire'}, {'measure': 'Change in adult BMI', 'timeFrame': 'twice annually for 3 years'}, {'measure': 'Change in adult intake of vegetables and fruit', 'timeFrame': 'twice annually for 3 years', 'description': 'skin carotenoid meter using reflection spectroscopy (veggie-meter)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Eating', 'Alaska Native', 'Traditional Foods'], 'conditions': ['Childhood Obesity']}, 'descriptionModule': {'briefSummary': 'The long-term goal of this community based participatory research project is to prevent obesity in 3-5 year old Alaska Native children in remote communities.\n\nInvestigators will design and evaluate a culturally responsive, home-focused intervention, Tundra Gifts, that links early childhood education programming (i.e. Head Start) and federal food assistance programs (i.e. WIC and SNAP) with primary caregivers to support healthy eating and an active lifestyle using a cluster-randomized design. The intervention integrates behavior change theory with Indigenous traditional knowledge. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site. Investigators will also evaluate key process indicators of Tundra Gifts to understand the impact on outcomes of variations in persons and settings and to enhance the generalizability of findings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 3-5 year old children enrolled in Head Start and their primary caregiver in Yup'ik Alaska Native communities"}, 'identificationModule': {'nctId': 'NCT03986632', 'briefTitle': 'Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities', 'organization': {'class': 'OTHER', 'fullName': 'University of Alaska Fairbanks'}, 'officialTitle': 'Tundra Gifts: Harvesting Local And Regional Resources To Prevent Obesity Among Alaska Native Children In Remote, Underserved Communities', 'orgStudyIdInfo': {'id': '2018-69001-27544'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tundra gifts program', 'interventionNames': ['Behavioral: Tundra Gifts']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison'}], 'interventions': [{'name': 'Tundra Gifts', 'type': 'BEHAVIORAL', 'description': 'Tundra Gifts is a home-focused intervention delivered by community health workers (CHW) that focuses on promoting healthy eating and an active lifestyle among 3-5 year olds through family and community partnerships. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site.', 'armGroupLabels': ['Tundra gifts program']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andrea Bersamin, PhD', 'role': 'CONTACT', 'email': 'abersamin@alaska.edu', 'phone': '(907)474-6129'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alaska Fairbanks', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pacific Institute for Research and Evaluation', 'class': 'OTHER'}, {'name': 'University of Alaska Anchorage', 'class': 'OTHER'}, {'name': 'State of Alaska Department of Health and Social Services', 'class': 'UNKNOWN'}, {'name': 'Grand Valley State University', 'class': 'OTHER'}, {'name': 'Alaska Native Tribal Health Consortium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrea Bersamin', 'investigatorAffiliation': 'University of Alaska Fairbanks'}}}}