{
  "FullStudy":{
    "Rank":218053,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513343",
          "OrgStudyIdInfo":{
            "OrgStudyId":"USDA 2011-68001-30009"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"H-28013",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"Baylor College of Medicine"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Baylor College of Medicine",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Promoting The Self-Regulation Of Energy Intake",
          "OfficialTitle":"Promoting The Self-Regulation Of Energy Intake In African American And Latino Preschoolers: A Family Focused Obesity Prevention Program",
          "Acronym":"SEEDs"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2014"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 27, 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 27, 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 1, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 4, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Sheryl Hughes",
            "ResponsiblePartyInvestigatorTitle":"Associate Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Baylor College of Medicine"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Baylor College of Medicine",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Washington State University",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"University of Colorado, Denver",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The goal of this study is to develop and test the efficacy of a scientifically-based, culturally competent seven-session parent directed, obesity prevention program focused on parental feeding strategies that support young children's self-regulation of intake.",
          "DetailedDescription":"The intervention program was developed and piloted. Expected outcomes: At the end of the intervention program, it is expected that parents in the intervention group will: 1) use more child-centered and less parent-centered feeding directives; 2) be less likely to show an indulgent and more likely to show an authoritative feeding style; 3)show lower scores on restriction and pressure to eat and higher scores on monitoring; and 4) demonstrate higher levels of food knowledge. Children in the intervention group are expected to: 1) show more willingness to try new foods, and 2) show increased self-regulation of energy intake. At the end of the interventions, children are expected to show greater consumption of fruits and vegetables (including consuming a wider variety of fruits and vegetables). All effects are expected to continue through the 6- and 12-month follow-ups, although the effects sizes will diminish. Although we do not expect effects on BMI after 6 weeks, we expect to see decreases in children's BMI percentiles by the 6- and 12-month follow-ups for the intervention group— especially for the top 25% of the BMI percentile range. No parental BMI effects are expected."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Obesity"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"330",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Parent and child classes",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Parent and child groups focused on self-regulation of eating",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Parent and child groups focused on self-regulation of eating"
                  ]
                }
              },{
                "ArmGroupLabel":"Treatment as usual",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Treatment as usual"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Parent and child groups focused on self-regulation of eating",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Parent and child classes"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"children's BMI percentiles",
                "PrimaryOutcomeTimeFrame":"up to 12-month follow-ups"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nParents whose children attend Head Start with the sample of children equally split on gender and ethnicity,\nwith representation from ages 3 to 6 years.\n\nExclusion Criteria:\n\nParents and children who have any kind of food allergies or diabetes or are on special diets will be excluded from the study.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"3 Years",
          "MaximumAge":"6 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Sheryl O Hughes, PhD",
                "OverallOfficialAffiliation":"Baylor College of Medicine",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Baylor College of Medicine",
                "LocationCity":"Houston",
                "LocationState":"Texas",
                "LocationZip":"77030",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Thomas G. Power",
                "LocationCity":"Pullman",
                "LocationState":"Washington",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "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":"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"
              }
            ]
          }
        }
      }
    }
  }
}