{
  "FullStudy":{
    "Rank":217909,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515254",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB11-00399"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"1R03DK089198-01A1",
                "SecondaryIdType":"U.S. NIH Grant/Contract",
                "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=1R03DK089198-01A1&Fy=all"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Nationwide Children's Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Feeding Dynamic Intervention: Self Regulation of Intake in Preschoolers",
          "OfficialTitle":"The Feeding Dynamic Intervention Study",
          "Acronym":"FeeDIn"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2018",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2018",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 28, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 2, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Ihuoma Eneli",
            "ResponsiblePartyInvestigatorTitle":"Medical Director, Center for Healthy Weight and Nutrition; Professor of Pediatrics, The Ohio State University",
            "ResponsiblePartyInvestigatorAffiliation":"Nationwide Children's Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Nationwide Children's Hospital",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",
                "CollaboratorClass":"NIH"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"In this study the investigators will examine the Feeding Dynamic Intervention (FDI) as a tool to prevent obesity in young children. The purpose of the intervention is to improving caregiver feeding practices, child eating behaviors, and child self-regulation of energy intake in the short term.",
          "DetailedDescription":"Childhood obesity is a significant public health problem. In the last three decade, there has been a marked increase in the prevalence of childhood obesity. Currently, 23% of preschoolers (2-5 years) in the United States are overweight or obese, a critical period to target in hopes of reversing this trend. The purpose of this study is to test the efficacy of a novel obesity intervention program for preschool-aged children. Emerging consensus indicates that excessive, intrusive, overt control in feeding or a chaotic non-structured feeding environment are risk factors for childhood obesity. The 2007 Expert Committee Recommendations on the Prevention, Assessment, and Treatment of Childhood Obesity specifically identified maternal feeding practices as important, categorically stating there is consistent evidence to support \"avoiding overly restrictive feeding behaviors.\" The guidelines emerged from a growing body of literature indicating that overly controlling caregiver feeding behaviors, in particular, significantly increase children's obesity risk.\n\nDespite the evidence for the importance of feeding dynamics, no childhood obesity interventions focused on this area have been rigorously tested. The Feeding Dynamic Intervention (FDI) is a 12-week educational intervention. The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. We will recruit 84 mothers with 3- to 5-year-old obese children, randomly assigned to either the FDI or a comparison to a waiting list control group (WLG). At the end of the 6 month study we will assess knowledge and behavioral changes between the groups on (i) maternal self-reported feeding practices; (ii) improving energy compensation (COMPX), decreasing Eating in the Absence of Hunger (EAH) and increasing mother-reported satiety responsiveness in their child. Finally, we will investigate an exploratory hypothesis that children in the FDI group, compared to children in the wait-list control group, will demonstrate a lower increase in body mass index (BMI) z-score over 6 months."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Children",
              "Exogenous Obesity",
              "Eating Behavior"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Children",
              "Obesity Prevention",
              "Child Overweight",
              "Energy Compensation",
              "Eating Behavior",
              "Food Intake",
              "Parenting Behavior"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"70",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"No intervention- control group",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken. The control group subjects will have the opportunity to receive the intervention at the end of the study"
              },{
                "ArmGroupLabel":"lifestyle counseling, parental feeding",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI). The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: lifestyle counseling, parental feeding"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"lifestyle counseling, parental feeding",
                "InterventionDescription":"Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI). The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "lifestyle counseling, parental feeding"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Increased Energy Regulation",
                "PrimaryOutcomeDescription":"Children in the FDI group, compared to children in the wait-list control group will show improved energy compensation regulation (COMPX), decreased Eating in the Absence of Hunger (EAH), and increasing Satiety Responsiveness (CEBQ-SR).",
                "PrimaryOutcomeTimeFrame":"Change from baseline in energy compensation at 3 months and Change from baseline in energy compensation at 6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Reduce BMI",
                "SecondaryOutcomeDescription":"Children in the FDI group, compared to children in the wait-list control group, will demonstrate a lower increase in body mass index (BMI) z-score over 6 months.",
                "SecondaryOutcomeTimeFrame":"Change from baseline in BMI-z score at 3 months and Change from baseline in BMI-z score at 6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nThe child is between ages 3-5 years (36 to 71 months). [Note if a family has more than one qualifying child we will choose the child with the lower CEBQ SR score and if they are equal we will randomly select the target child for the study dyad.]\nChild's body mass index > 85th percentile for age and sex\nThis will be calculated based on age, weight and height using the Center for Healthy Weight and Nutrition BMI calculator [if mother is unsure of the weight and height ask whether she has been told her child is overweight or obese by the PCP]\nChild has significantly abnormal parent-reported impairment of energy regulation (Rating of 2.8 or lower on the CEB-Q).\nThe mother is fluent in English (measures are limited to English at this time)\nMother (or female caregiver) has primary legal and physical custody of the child and is primarily responsible for feeding the child. Specifically the child is not in a non-parental home daycare more than 20 hours/week. Structured child care centers are not included in this limitation because they use structure care and feeding techniques similar to those taught in the FeeDIn Program.\n\nExclusion Criteria:\n\nChild has a medical condition or takes a medication that affects appetite, eating, or growth;\nChild has food allergies or dietary restrictions that interfere with feeding or the study tests (i.e., milk, gluten and eggs?)\nChild has any developmental or behavioral diagnosis that might affect his/her ability to respond to a behaviorally-based intervention, e.g., cognitive impairment, language delay, or autism.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"3 Years",
          "MaximumAge":"5 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Ihuoma Eneli, MD, MS",
                "OverallOfficialAffiliation":"Nationwide Children's Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Nationwide Children's Hospital",
                "LocationCity":"Columbus",
                "LocationState":"Ohio",
                "LocationZip":"43205",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25616192",
                "ReferenceType":"background",
                "ReferenceCitation":"Eneli IU, Tylka TL, Hummel J, Watowicz RP, Perez SA, Kaciroti N, Lumeng JC. Rationale and design of the Feeding Dynamic Intervention (FDI) study for self-regulation of energy intake in preschoolers. Contemp Clin Trials. 2015 Mar;41:325-34. doi: 10.1016/j.cct.2015.01.006. Epub 2015 Jan 20."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009765",
                "ConditionMeshTerm":"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":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}