{
  "FullStudy":{
    "Rank":217859,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515904",
          "OrgStudyIdInfo":{
            "OrgStudyId":"1000025502"
          },
          "Organization":{
            "OrgFullName":"The Hospital for Sick Children",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Evaluation of the SickKids Team Obesity Management Program",
          "OfficialTitle":"Evaluation of the SickKids Team Obesity Management Program (STOMP)",
          "Acronym":"STOMP"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2019",
          "OverallStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2020",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2021",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 5, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 9, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jill Hamilton",
            "ResponsiblePartyInvestigatorTitle":"Staff Endocrinologist",
            "ResponsiblePartyInvestigatorAffiliation":"The Hospital for Sick Children"
          },
          "LeadSponsor":{
            "LeadSponsorName":"The Hospital for Sick Children",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In January 2010 a new interdisciplinary clinic (STOMP) was created to provide care for children and adolescents with severe 'complex' obesity. As part of the program, a subset of adolescents undergo bariatric surgery. There is a paucity of literature evaluating outcomes of children and adolescents participating in a 'clinical' setting and even fewer reports of outcomes of severely obese pediatric patients. Previously, the investigators evaluated clinical outcomes of children with craniopharyngioma and hypothalamic obesity attending an outpatient interdisciplinary program at SickKids (The Comprehensive Care Clinic for Children with Central Tumours) and found significant benefit to those attending, including reduction of weight gain (or weight loss), improved psychosocial functioning, and increased care satisfaction. STOMP is a natural extension of this program, incorporating some core elements (e.g., interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a \"key worker\" (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions. Evaluation of the outcomes of this clinic is needed to inform best practice for children and adolescents with severe complex obesity",
          "DetailedDescription":"The primary objective is to conduct an evaluation of the STOMP clinic as a model of care with a specific focus on: (i) patient outcomes (anthropometric, metabolic, and psychosocial); and (ii) care coordination and care satisfaction.\n\nPatient outcomes will be compared against baseline evaluation data over time, and to a control group of patients not enrolled in the program, but who expressed interest in the program and were unable to attend."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Obesity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "obesity management",
              "adolescents",
              "body mass index",
              "treatment outcomes",
              "program evaluation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case-Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"400",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Control"
              },{
                "ArmGroupLabel":"STOMP",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: STOMP Clinic"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"STOMP Clinic",
                "InterventionDescription":"A new interdisciplinary clinic (STOMP) was created to provide care for children and adolescents with severe 'complex' obesity. As part of the program, a subset of adolescents undergo bariatric surgery. The core elements include an interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a \"key worker\" (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "STOMP"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Body Mass Index",
                "PrimaryOutcomeDescription":"BMI will be measured at Baseline and 12 months after treatment to evaluate change",
                "PrimaryOutcomeTimeFrame":"Baseline"
              },{
                "PrimaryOutcomeMeasure":"Body Mass Index",
                "PrimaryOutcomeDescription":"BMI will be measured at Baseline and 12 months after treatment to evaluate change",
                "PrimaryOutcomeTimeFrame":"12 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Systolic and Diastolic Blood Pressure",
                "SecondaryOutcomeDescription":"Systolic and Diastolic Blood Pressure will be measured at Baseline and 12 months after treatment to evaluate change",
                "SecondaryOutcomeTimeFrame":"Baseline, 12 months"
              },{
                "SecondaryOutcomeMeasure":"Lipid profile",
                "SecondaryOutcomeDescription":"The lipid profile (including total cholesterol, LDL cholesterol, HDL cholesterol, non-HDL cholesterol and triglycerides) will be measured at Baseline and 12 months after treatment to evaluate change",
                "SecondaryOutcomeTimeFrame":"Baseline and 12 months"
              },{
                "SecondaryOutcomeMeasure":"Glycemic control and Insulin resistance",
                "SecondaryOutcomeDescription":"Glycemic control will be measured by HbA1c values and insulin resitance will be assed by HOMA-IR",
                "SecondaryOutcomeTimeFrame":"Baseline and 12 months"
              },{
                "SecondaryOutcomeMeasure":"Health and weight-related quality of life",
                "SecondaryOutcomeDescription":"This outcome measure will be assessed by the Pediatric Quality of Life Inventory (PedsQL)) and the impact of Weight on Quality of Life (IWQOL)",
                "SecondaryOutcomeTimeFrame":"Baseline and 12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAll patients enrolled in the STOMP program are eligible to participate in the study.\nControl participants must be between 12-18 years of age with a BMI >95th percentile for age.\n\nExclusion Criteria:\n\n- Control participants cannot be enrolled in the STOMP program.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"12 Years",
          "MaximumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          },
          "StudyPopulation":"STOMP Group: 12-17 years of age. Patients in the program have severe complex obesity which is defined as as children and youth who have a BMI >95th percentile for their age and gender in addition to any one of the following: at least one significant obesity-related co-morbidity requiring specialty care (e.g. type 2 diabetes, hypertension), other co-existing chronic illness impacted by obesity (e.g. CNS tumor, post-organ transplant), or a BMI ≥99th percentile for their age and gender\n\nControl: Approximately 50% of attendees choose not to book into the program, for reasons including difficulty attending the frequent appointments due to distance or inability to leave work early. This population will serve as the control group for the evaluation. In addition, control participants will be recruited from the community through posters posted in the hospital.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Jill Hamilton",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"416-813-5115",
                "CentralContactPhoneExt":"205115",
                "CentralContactEMail":"jill.hamilton@sickkids.ca"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jill Hamilton, MD",
                "OverallOfficialAffiliation":"The Hospital for Sick Children",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"The Hospital for Sick Children",
                "LocationStatus":"Recruiting",
                "LocationCity":"Toronto",
                "LocationState":"Ontario",
                "LocationZip":"M5V1X8",
                "LocationCountry":"Canada",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Jill Hamilton, MD",
                      "LocationContactRole":"Principal Investigator"
                    }
                  ]
                }
              }
            ]
          }
        }
      },
      "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"
              }
            ]
          }
        }
      }
    }
  }
}