{
  "FullStudy":{
    "Rank":218272,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510483",
          "OrgStudyIdInfo":{
            "OrgStudyId":"5R01CA138192",
            "OrgStudyIdType":"U.S. NIH Grant/Contract",
            "OrgStudyIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=5R01CA138192&Fy=all"
          },
          "Organization":{
            "OrgFullName":"San Diego State University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents: HEALTHY SMILES",
          "OfficialTitle":"Clinician Promotion of Healthy Diet and Activity to Reduce Obesity Among Adolescents",
          "Acronym":"HS"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2018",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"November 14, 2011",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 16, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 18, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Melbourne Hovell",
            "ResponsiblePartyInvestigatorTitle":"Director of CBEACH, Distinguished Professor of Public Health",
            "ResponsiblePartyInvestigatorAffiliation":"San Diego State University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"San Diego State University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This study will test an 18-month intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets or reduce tobacco use and exposure among preteens who obtain orthodontic care. Relevance: If successful, this study may inform policies that would promote all specialists (orthodontists, physicians, general dentists) to deliver brief counseling for diet, physical activity, and tobacco prevention.",
          "DetailedDescription":"This study will test a 18-month multi-component intervention designed to increase physical activity, reduce sedentary practices and promote healthy diets among preteens who obtain orthodontic care. The intervention is based on the Behavioral Ecological Model (BEM), where interacting physiological, environmental, and cultural contingencies select behavior. This study will require five years to recruit 40 orthodontist offices, and 1700 youth, and implement an office-wide intervention for promoting healthy diet and physical activity among 8-14 yr old youth. Our primary aims are to detect a differential change in diet, physical activity and BMI in our experimental group compared to the tobacco prevention control group; to observe differential effects of the intervention between low vs. high SES; and similarly for males vs. females; to validate our primary outcome variables by contrasting them with a \"gold standard\"; and determine the degree to which family and peer encouragement for sedentary and high caloric diet at baseline increases the relative effect of the orthodontist intervention. Offices will be assigned at random to condition producing a 2 (experimental group) by 2 strata (low vs. high SES) by 2 strata (male vs. female) by 4 (repeated measures) experimental design. Those in the experimental condition will be exposed to the office-wide intervention for diet and activity; those in the control condition will be exposed to an office-wide intervention for tobacco prevention. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents. Measures of diet, physical activity, body composition, tobacco use, fitness and family and peer encouragement will occur at baseline, 12, 18, and 24 months. Differential change over time will be analyzed using Random Effects Multivariate modeling. Analyses will include control for office cluster effects and multivariate models will include analyses of hypothetical main effects, experimental group by time interactions, and moderating effects by inclusion of interaction terms for susceptibility by experimental condition and other possible moderators. Relevance: If successful, this study may inform policies that would promote all specialists (physicians, general dentists) to deliver brief counseling for diet and physical activity. Doing so might yield the cumulative exposure necessary to effect and sustain change in a large proportion of the preteen population."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Obesity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "obesity prevention",
              "tobacco prevention",
              "nutrition",
              "physical activity",
              "sedentary activity",
              "tobacco use",
              "tobacco exposure",
              "prevention",
              "clinician intervention",
              "preteen",
              "adolescents"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"693",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Obesity prevention",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Orthodontist promotion of physical activity and healthy diet",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Obesity Prevention"
                  ]
                }
              },{
                "ArmGroupLabel":"Tobacco prevention",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Orthodontist promotion of tobacco and second hand smoke avoidance",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Tobacco Prevention"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Obesity Prevention",
                "InterventionDescription":"Those in the experimental, obesity prevention, condition will be exposed to the office-wide intervention for diet and activity. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Obesity prevention"
                  ]
                }
              },{
                "InterventionType":"Behavioral",
                "InterventionName":"Tobacco Prevention",
                "InterventionDescription":"Those in the control, tobacco prevention, condition will be exposed to the office-wide intervention for avoidance of tobacco and second hand smoke. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Tobacco prevention"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in Body Mass Index",
                "PrimaryOutcomeDescription":"Body Mass Index assessed at Baseline, 12 month, 18 months and 24 months; and every 6-8 weeks during intervention period.",
                "PrimaryOutcomeTimeFrame":"Baseline, 2, 4, 6, 8, 10, 12, 14, 16, 18, 24 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in physical and sedentary activity",
                "SecondaryOutcomeTimeFrame":"Baseline, 12, 18 and 24 months"
              },{
                "SecondaryOutcomeMeasure":"Change in dietary intake",
                "SecondaryOutcomeTimeFrame":"Baseline, 12, 18 and 24 months"
              },{
                "SecondaryOutcomeMeasure":"Change in tobacco use and exposure",
                "SecondaryOutcomeTimeFrame":"Baseline, 12, 18 and 24 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n8-14 years old\nreceiving orthodontic care at a participating orthodontic office\nat least 1 year left in braces\n\nExclusion Criteria:\n\nparticipating in 9 or more months of structured\norganized sports for 3 or more days a week, youth who have serious conditions that preclude physical activity or make the child incapable of managing his/her own care will not qualify for this study\nindividuals who report anorexia, bulimia or severe, diagnosed depression will not be eligible",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"8 Years",
          "MaximumAge":"14 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Melbourne F Hovell, PhD, MPH",
                "OverallOfficialAffiliation":"SDSU/GSPH",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"SDSU-Center for Behavioral Epidemiology & Community Health",
                "LocationCity":"San Diego",
                "LocationState":"California",
                "LocationZip":"92123",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"8935468",
                "ReferenceType":"background",
                "ReferenceCitation":"Hovell MF, Slymen DJ, Keating KJ, Jones JA, Burkham-Kreitner S, Hofstetter CR, Noel D, Rubin B. Tobacco use prevalence and correlates among adolescents in a clinician initiated tobacco prevention trial in California, USA. J Epidemiol Community Health. 1996 Jun;50(3):340-6."
              },{
                "ReferencePMID":"9003134",
                "ReferenceType":"background",
                "ReferenceCitation":"Hovell MF, Slymen DJ, Jones JA, Hofstetter CR, Burkham-Kreitner S, Conway TL, Rubin B, Noel D. An adolescent tobacco-use prevention trial in orthodontic offices. Am J Public Health. 1996 Dec;86(12):1760-6."
              },{
                "ReferencePMID":"9291217",
                "ReferenceType":"background",
                "ReferenceCitation":"Wahlgren DR, Hovell MF, Slymen DJ, Conway TL, Hofstetter CR, Jones JA. Predictors of tobacco use initiation in adolescents: a two-year prospective study and theoretical discussion. Tob Control. 1997 Summer;6(2):95-103."
              },{
                "ReferencePMID":"19928484",
                "ReferenceType":"background",
                "ReferenceCitation":"Hovell MF, Nichols JF, Irvin VL, Schmitz KE, Rock CL, Hofstetter CR, Keating K, Stark LJ. Parent/Child training to increase preteens' calcium, physical activity, and bone density: a controlled trial. Am J Health Promot. 2009 Nov-Dec;24(2):118-28. doi: 10.4278/ajhp.08021111."
              },{
                "ReferencePMID":"11072456",
                "ReferenceType":"background",
                "ReferenceCitation":"Zakarian JM, Hovell MF, Conway TL, Hofstetter CR, Slymen DJ. Tobacco use and other risk behaviors: cross-sectional and predictive relationships for adolescent orthodontic patients. Nicotine Tob Res. 2000 May;2(2):179-86."
              },{
                "ReferencePMID":"9010897",
                "ReferenceType":"background",
                "ReferenceCitation":"Russos S, Hovell MF, Keating K, Jones JA, Burkham SM, Slymen DJ, Hofstetter CR, Rubin B. Clinician compliance with primary prevention of tobacco use: the impact of social contingencies. Prev Med. 1997 Jan-Feb;26(1):44-52."
              },{
                "ReferencePMID":"9279608",
                "ReferenceType":"background",
                "ReferenceCitation":"Slymen DJ, Hovell MF. Cluster versus individual randomization in adolescent tobacco and alcohol studies: illustrations for design decisions. Int J Epidemiol. 1997 Aug;26(4):765-71."
              },{
                "ReferencePMID":"8573357",
                "ReferenceType":"background",
                "ReferenceCitation":"Hovell MF, Russos S, Beckhelm MK, Jones JA, Burkham-Kreitner SM, Slymen DJ, Hofstetter CR, Rubin B. Compliance with primary prevention in private practice: creating a tobacco-free environment. Am J Prev Med. 1995 Sep-Oct;11(5):288-93."
              },{
                "ReferencePMID":"10419794",
                "ReferenceType":"background",
                "ReferenceCitation":"Russos S, Keating K, Hovell MF, Jones JA, Slymen DJ, Hofstetter CR, Rubin B, Morrison T. Counseling youth in tobacco-use prevention: determinants of clinician compliance. Prev Med. 1999 Jul;29(1):13-21."
              },{
                "ReferencePMID":"11336120",
                "ReferenceType":"background",
                "ReferenceCitation":"Hovell MF, Jones JA, Adams MA. The feasibility and efficacy of tobacco use prevention in orthodontics. J Dent Educ. 2001 Apr;65(4):348-53."
              },{
                "ReferencePMID":"9315423",
                "ReferenceType":"background",
                "ReferenceCitation":"Morrison TC, Wahlgren DR, Hovell MF, Zakarian J, Burkham-Kreitner S, Hofstetter CR, Slymen DJ, Keating K, Russos S, Jones JA. Tracking and follow-up of 16,915 adolescents: minimizing attrition bias. Control Clin Trials. 1997 Oct;18(5):383-96."
              },{
                "ReferenceType":"background",
                "ReferenceCitation":"Keating KJ, Russos S, Hovell MF, Jones JA, Wahlgren D. Creating tobacco-free environments in clinicians' offices: Do patients notice? J Health Educ 2000;31(1):37-41."
              },{
                "ReferencePMID":"26645420",
                "ReferenceType":"result",
                "ReferenceCitation":"Cisse-Egbuonye N, Liles S, Schmitz KE, Kassem N, Irvin VL, Hovell MF. Availability of Vending Machines and School Stores in California Schools. J Sch Health. 2016 Jan;86(1):48-53. doi: 10.1111/josh.12349."
              },{
                "ReferencePMID":"29747047",
                "ReferenceType":"derived",
                "ReferenceCitation":"Hovell MF, Schmitz KE, Liles S, Robusto K, Hofstetter CR, Nichols JF, Rock CL, Irvin V, Parker MS, Surillo SA, Noel D. A randomized controlled trial of orthodontist-based brief advice to prevent child obesity. Contemp Clin Trials. 2018 Jul;70:53-61. doi: 10.1016/j.cct.2018.05.003. Epub 2018 May 7."
              }
            ]
          }
        }
      },
      "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"
              }
            ]
          }
        }
      }
    }
  }
}