{ "FullStudy":{ "Rank":218264, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510587", "OrgStudyIdInfo":{ "OrgStudyId":"4W3685" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2009-55215-05334", "SecondaryIdType":"Other Grant/Funding Number", "SecondaryIdDomain":"USDA-NIFA-AFRI" } ] }, "Organization":{ "OrgFullName":"Montana State University", "OrgClass":"OTHER" }, "BriefTitle":"Family Influences to Prevent Childhood Obesity", "OfficialTitle":"Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth", "Acronym":"4-Health" }, "StatusModule":{ "StatusVerifiedDate":"January 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 7, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 16, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 28, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 29, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Wesley Lynch", "ResponsiblePartyInvestigatorTitle":"Professor of Psychology", "ResponsiblePartyInvestigatorAffiliation":"Montana State University" }, "LeadSponsor":{ "LeadSponsorName":"Montana State University", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"USDA Beltsville Human Nutrition Research Center", "CollaboratorClass":"FED" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight.", "DetailedDescription":"Previous studies suggest that parents can play a key role in preventing childhood obesity. Program objectives are to increase parents' knowledge and skills related to nutrition, physical activity, and best parenting practices. Developed from a successful existing program, the proposed program will include a novel classroom curriculum coupled with outside exercises, online resources, and a strong social support network. The curriculum will be developed with input from stakeholders during year 1 and implemented during years 2 and 3. The target groups are children and parents participating in 4-H Youth Development Programs in Montana. Intervention effectiveness will be assessed by comparing objective and self-report data between-groups (intervention vs. control) and within-groups (pre- to post-intervention and at 6 month follow-up). Physiological measures, including resting heart rate, blood pressure, body weight and age- and gender-specific BMI z-scores of children, are expected to show significant improvement among children of parents receiving the intervention compared to a mailed written materials control group. In addition, positive changes are anticipated in outcome measures provided by parents and children, including levels of daily physical activity and specific food and nutrition behaviors. Positive changes in parents' attitudes about diet, body image, and their perceived feeding practices before versus after intervention and at 6 month follow-up are also expected. This project will lead to improved understanding of how parents influence child obesity and improved interventions to prevent obesity." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Childhood Obesity" ] }, "KeywordList":{ "Keyword":[ "obesity", "prevention", "preteen", "nutrition", "physical activity", "body image", "family dynamics" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"194", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"4-Health Educational curriculum", "ArmGroupType":"Experimental", "ArmGroupDescription":"Parents participate in 10 face-to-face educational sessions delivered by Extension Agents at individual county locations over a 8-month period (fall to spring).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: 4-Health Educational curriculum" ] } },{ "ArmGroupLabel":"Healthy Living Information", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Participants receive 10 mailed packets of written information derived from USDA's MyPlate website on approximately the same schedule as meetings of the experimental group.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Healthy Living Information" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"4-Health Educational curriculum", "InterventionDescription":"During the intervention, parents meet about every 3 weeks (90 min/session) in small groups with facilitators. During meetings classroom activities aim to integrate 3 areas: 1) parents' knowledge about healthy diets, physical activity and improved body image; 2) parents' understanding, skills and potential roles as positive change-agents (i.e., parenting and behavior management); and 3) parents' learning and practicing cognitive-behavioral exercises that encourage specific skills within the family/home setting. Between monthly meetings, participants explore a suggested online websites or facilitator-assigned questions and provide feedback. The majority of outside time/assignments for parents is spent doing take-home activities with their preteen child and family.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "4-Health Educational curriculum" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "4-Health Educational Program" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Healthy Living Information", "InterventionDescription":"During the Healthy Living Information intervention, participants receive packets delivered to their homes by mail at intervals similar to the meeting intervals for the educational curriculum intervention. (10 total packets.) Approximately every three weeks between late September 2011 and April 2012, corresponding approximately to the meeting times for the 4-Health Educational Program, participants in the Healthy Living Information control group receive mailed packets of information.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Healthy Living Information" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change child body mass index z-score.", "PrimaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change in youth and parent self-reported physical activity.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in child and parent physical activity self-efficacy.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in child and parent dietary self-efficacy.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in child and parent body image.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in child quality of life via self-report and parent report.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in parent body mass index.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in child and parent diastolic and systolic blood pressure.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" },{ "SecondaryOutcomeMeasure":"Change in child and parent heart rate.", "SecondaryOutcomeTimeFrame":"Baseline, end of program, 6 month follow up" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nParent of 8-12 year old child in 4-H Youth Development Programs in Montana\nChild of parent enrolled in study\n\nExclusion Criteria:\n\nParent of child age outside the 8-12 year old range at start of trial", "HealthyVolunteers":"No", "Gender":"All", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Wesley Lynch, PhD", "OverallOfficialAffiliation":"Montana State University", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Lynn Paul, PhD, RD", "OverallOfficialAffiliation":"Montana State University", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Jill Martz, PhD", "OverallOfficialAffiliation":"Montana State University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Montana State University", "LocationCity":"Bozeman", "LocationState":"Montana", "LocationZip":"59717", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"22471650", "ReferenceType":"derived", "ReferenceCitation":"Lynch WC, Martz J, Eldridge G, Bailey SJ, Benke C, Paul L. Childhood obesity prevention in rural settings: background, rationale, and study design of '4-Health,' a parent-only intervention. BMC Public Health. 2012 Apr 2;12:255. doi: 10.1186/1471-2458-12-255." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Benke CJ, Bailey SJ, Paul L, Lynch W, Eldridge G. Developing a Parent-Centered Obesity Prevention Program for 4-H Families: Implications for Extension Family Programming. Journal of Extension 51(3), 2013.", "SeeAlsoLinkURL":"http://www.joe.org/joe/2013june/a8.php" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009765", "ConditionMeshTerm":"Obesity" },{ "ConditionMeshId":"D000063766", "ConditionMeshTerm":"Pediatric Obesity" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044343", "ConditionAncestorTerm":"Overnutrition" },{ "ConditionAncestorId":"D000009748", "ConditionAncestorTerm":"Nutrition Disorders" },{ "ConditionAncestorId":"D000050177", "ConditionAncestorTerm":"Overweight" },{ "ConditionAncestorId":"D000001835", "ConditionAncestorTerm":"Body Weight" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11284", "ConditionBrowseLeafName":"Obesity", "ConditionBrowseLeafAsFound":"Obesity", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M28742", "ConditionBrowseLeafName":"Pediatric Obesity", "ConditionBrowseLeafAsFound":"Childhood Obesity", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M23894", "ConditionBrowseLeafName":"Overnutrition", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11267", "ConditionBrowseLeafName":"Nutrition Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M24773", "ConditionBrowseLeafName":"Overweight", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3696", "ConditionBrowseLeafName":"Body Weight", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }