Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01071551
Status:
UNKNOWN
Last Update Posted:
2010-02-19
First Post:
2010-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality, Physical Activity and Dental Health Among Children From Socioeconomically Disadvantaged Families in Beer Sheva
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-18', 'studyFirstSubmitDate': '2010-02-18', 'studyFirstSubmitQcDate': '2010-02-18', 'lastUpdatePostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's weight and Height", 'timeFrame': 'Baseline, post intervention and at 4 months post intervention termination'}], 'secondaryOutcomes': [{'measure': 'Caries rate (DMFT score)', 'timeFrame': 'Baseline, post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'Obesity', 'Lifestyle', 'LSES', 'Caries'], 'conditions': ['Childhood Obesity']}, 'referencesModule': {'references': [{'pmid': '23620192', 'type': 'DERIVED', 'citation': 'Kaufman-Shriqui V, Werbeloff N, Faroy M, Meiri G, Shahar DR, Fraser D, Novack Y, Bilenko N, Vardi H, Elhadad N, Pietrzak RH, Harpaz-Rotem I. Posttraumatic stress disorder among preschoolers exposed to ongoing missile attacks in the Gaza war. Depress Anxiety. 2013 May;30(5):425-31. doi: 10.1002/da.22121.'}]}, 'descriptionModule': {'briefSummary': 'Childhood socioeconomic status (SES) is related to poor physical health, obesity, elevated cardiovascular risk factors and iron deficiency anemia. We plan to offer a comprehensive framework allowing the "Nutrition Enrichment and Healthy Living Model" (NEHLM) among a low SES Kindergarten children. The model offered is designed to take into account the current economic status of the child\'s family. We shall conduct a randomized controlled trial to assess the efficacy of the intervention.\n\nOur main objective:\n\nTo compare the influence of the intervention on changes in food consumption, physical activity and ,and caries rates in the children in kindergartens where it is applied versus the control kindergartens.\n\nThe research hypothesis:\n\nIntegrative Nutrition Enrichment and Healthy Living Model (NEHLM) will improve health behaviors among children and parents in comparison to control intervention (physical activity only).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '84 Months', 'minimumAge': '48 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kindergarten children aged 4-7 Children from kindergartens defined as Low- SES population (by local municipality)\n* Children whose parents agree to participate in the research\n\nExclusion Criteria:\n\n* Children who suffer from any chronic disease\n* Children who suffer from developmental problems\n* Children who participate in a weight reduction treatment or program\n* Children or parents who have any psychiatric problem or diagnosis'}, 'identificationModule': {'nctId': 'NCT01071551', 'acronym': 'NEHLM', 'briefTitle': 'The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality, Physical Activity and Dental Health Among Children From Socioeconomically Disadvantaged Families in Beer Sheva', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'The Impact of the "Nutrition Enrichment and Healthy Living Model" ( NEHLM) on Diet Quality.', 'orgStudyIdInfo': {'id': 'SOR471208CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle and health promotion', 'description': 'The "Nutrition Enrichment and Healthy Living Model" (NEHLM) is an Integrative model covering variety of lifestyle issues such as nutrition, dental care, and physical activity. The model will be applied to kindergartens and a sample of their parents. Children participating will be given 10 lessons in nutrition, 5 lessons in dental-care and 20 physical activity lessons. Parents for children in this group will be given 2 nutrition-education meetings and a meeting with a dental clinician.2 additional meetings will be held for parents and children together, one in nutrition and one in dental-care.', 'interventionNames': ['Behavioral: Life-style intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physical activity only', 'description': 'Children allocated to this group will attend physical activity classes only.', 'interventionNames': ['Behavioral: Physical activity only']}], 'interventions': [{'name': 'Life-style intervention', 'type': 'BEHAVIORAL', 'description': 'The "Nutrition Enrichment and Healthy Living Model" (NEHLM) is an Integrative model covering variety of lifestyle issues such as nutrition, dental care, and physical activity. The model will be applied to kindergartens and a sample of their parents. Children participating will be given 10 lessons in nutrition, 5 lessons in dental-care and 20 physical activity lessons. Parents for children in this group will be given 2 nutrition-education meetings and a meeting with a dental clinician.2 additional meetings will be held for parents and children together, one in nutrition and one in dental-care.', 'armGroupLabels': ['Lifestyle and health promotion']}, {'name': 'Physical activity only', 'type': 'BEHAVIORAL', 'description': 'Children allocated to this group will attend 20 physical activity classes.', 'armGroupLabels': ['Physical activity only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'country': 'Israel', 'facility': 'Kindergardens', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}], 'overallOfficials': [{'name': 'Natalya Bilenko, MD, M.PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ben Gurion Universty of the Negev Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Natalya Bilenko', 'oldOrganization': 'Ben-Gurion University of the Negev Israel'}}}}