{
  "FullStudy":{
    "Rank":217983,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514279",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IMPACT-1-5U01HL103622-02"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"5U01HL103622-02",
                "SecondaryIdType":"U.S. NIH Grant/Contract",
                "SecondaryIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=5U01HL103622-02&Fy=all"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Case Western Reserve University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Ideas Moving Parents and Adolescents to Change Together (IMPACT)",
          "OfficialTitle":"Targeting Obesity and Blood Pressure in Urban Youth(Consortium Title: Childhood Obesity Prevention and Treatment Research [COPTR] and Site Project Name IMPACT (Ideas Moving Parents and Adolescents to Change Together).",
          "Acronym":"IMPACT"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 1, 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 21, 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 31, 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 20, 2011",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 15, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 19, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Elaine Borawski",
            "ResponsiblePartyInvestigatorTitle":"Angela Bowen Williamson Professor of Community Nutrition, Director, Prevention Research Center for Healthy Neighborhoods",
            "ResponsiblePartyInvestigatorAffiliation":"Case Western Reserve University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Case Western Reserve University",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Heart, Lung, and Blood Institute (NHLBI)",
                "CollaboratorClass":"NIH"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled \"Targeting Obesity and Blood Pressure in Urban Youth\". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together).\n\nThe project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes.\n\nThe project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.",
          "DetailedDescription":"The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE).\n\nIn the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program.\n\nThis study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Overweight",
              "Obese"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Overweight",
              "Obese",
              "Over Nutrition",
              "Nutrition Disorders",
              "Body weight",
              "Signs and Symptoms"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"360",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"HealthyCHANGE",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: HealthyCHANGE"
                  ]
                }
              },{
                "ArmGroupLabel":"SystemCHANGE",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: SystemCHANGE"
                  ]
                }
              },{
                "ArmGroupLabel":"Tools4CHANGE",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior."
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"HealthyCHANGE",
                "InterventionDescription":"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.\n\nIt involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "HealthyCHANGE"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"SystemCHANGE",
                "InterventionDescription":"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.\n\nIt involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "SystemCHANGE"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Slope of Body Mass Index (BMI)",
                "PrimaryOutcomeTimeFrame":"[Baseline, 12 mos, 24 mos and 36 mos]"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Dietary Intake",
                "SecondaryOutcomeTimeFrame":"[Baseline, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Blood Pressure",
                "SecondaryOutcomeTimeFrame":"[Baseline, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Physical Activity",
                "SecondaryOutcomeTimeFrame":"[Baseline, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Sleep",
                "SecondaryOutcomeTimeFrame":"[Baseline, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Cardiovascular Risk Factors",
                "SecondaryOutcomeTimeFrame":"[Baseline, 8 mos, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Body Composition",
                "SecondaryOutcomeTimeFrame":"[Baseline, 8 mos, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Fitness",
                "SecondaryOutcomeTimeFrame":"[Baseline, 8 mos, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"Quality of Life",
                "SecondaryOutcomeTimeFrame":"[Baseline, 8 mos, 12 mos, 24 mos and 36 mos]"
              },{
                "SecondaryOutcomeMeasure":"DNA",
                "SecondaryOutcomeTimeFrame":"[1 Day]"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nStudents entering the 6th grade who are found at the standard school screenings to be overweight or obese\n(BMI 85th- 94th percentile or > 95th percentile for age/sex respectively)\n\nExclusion Criteria:\n\nTaking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones)\nInability to understand English\nStage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria)\nSevere behavioral problems that preclude group participation (as reported by parent/guardian)\nChild involvement in another weight management program\nFamily expectation to move from the region within 1 year\nThe presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"11 Years",
          "MaximumAge":"15 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Elaine A Borawski, PhD",
                "OverallOfficialAffiliation":"Case Western Reserve University",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Shirley M Moore, RN, PhD",
                "OverallOfficialAffiliation":"Case Western Reserve University",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Case Western Reserve University",
                "LocationCity":"Cleveland",
                "LocationState":"Ohio",
                "LocationZip":"44106",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24008055",
                "ReferenceType":"background",
                "ReferenceCitation":"Moore SM, Borawski EA, Cuttler L, Ievers-Landis CE, Love TE. IMPACT: a multi-level family and school intervention targeting obesity in urban youth. Contemp Clin Trials. 2013 Nov;36(2):574-86. doi: 10.1016/j.cct.2013.08.009. Epub 2013 Sep 2."
              },{
                "ReferencePMID":"31138278",
                "ReferenceType":"derived",
                "ReferenceCitation":"Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0."
              },{
                "ReferencePMID":"31126971",
                "ReferenceType":"derived",
                "ReferenceCitation":"Moore SM, Borawski EA, Love TE, Jones S, Casey T, McAleer S, Thomas C, Adegbite-Adeniyi C, Uli NK, Hardin HK, Trapl ES, Plow M, Stevens J, Truesdale KP, Pratt CA, Long M, Nevar A. Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial. Pediatrics. 2019 Jun;143(6). pii: e20182185. doi: 10.1542/peds.2018-2185."
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"Yes",
          "IPDSharingDescription":"Conducted in conjunction with the Research Coordinating Unit (UNC Chapel Hill) of the COPTR Consortium."
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000050177",
                "ConditionMeshTerm":"Overweight"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001835",
                "ConditionAncestorTerm":"Body Weight"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafAsFound":"Overweight",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M28742",
                "ConditionBrowseLeafName":"Pediatric Obesity",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}