{
  "FullStudy":{
    "Rank":217964,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514539",
          "OrgStudyIdInfo":{
            "OrgStudyId":"P20RR016474",
            "OrgStudyIdType":"U.S. NIH Grant/Contract",
            "OrgStudyIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P20RR016474&Fy=all"
          },
          "Organization":{
            "OrgFullName":"University of Wyoming",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk",
          "OfficialTitle":"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 7, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 9, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Enette Larson-Meyer",
            "ResponsiblePartyInvestigatorTitle":"Phd, RD, FACSM",
            "ResponsiblePartyInvestigatorAffiliation":"University of Wyoming"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Wyoming",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Hormonal Regulation of Postpartum Weight and Presence of Gut Peptides in Human Milk Studies suggest that childbearing is an important contributor to the development of obesity in many women and that breastfeeding may be protective.\n\nGhrelin and peptide YY (PYY) are gut hormones involved in appetite regulation and energy homeostasis and are biological neuroendocrine signals that potentially affect body weight and adiposity/",
          "DetailedDescription":"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk.\n\nThis study evaluated whether fasting or postprandial ghrelin or PYY is different between lactating and nonlactating postpartum women matched for age, body weight, and adiposity.\n\nEligibility Criteria: Healthy females, 18+ years old, non-smokers, no major food allergies, first-time mom, currently pregnant or within 1 month of giving birth."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Maternal Obesity Syndrome"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Human milk, Ghrelin,PYY and maternal obesity."
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Non-Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Prevention",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"44",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Four weeks Postpartum Lactating",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"women between 18 and 45 who delivered their first child 4 weeks prior and who were currently lactating and planning to lactate for one year postpartum.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: cross-sectional"
                  ]
                }
              },{
                "ArmGroupLabel":"Control Never Pregnant",
                "ArmGroupType":"Other",
                "ArmGroupDescription":"women between 18 and 45 who have never been pregnant",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: cross-sectional"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"cross-sectional",
                "InterventionDescription":"Monitoring two recently discovered appetite hormones called \"ghrelin\" and \"neuropeptide YY (PYY).\" This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Control Never Pregnant",
                    "Four weeks Postpartum Lactating"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"\"Role of Ghrelin and PYY in Postpartum Body Weight Regulation and Presence in Human Milk\"",
                "PrimaryOutcomeDescription":"Biomedical Research Study that will provide information on reducing maternal obesity.",
                "PrimaryOutcomeTimeFrame":"5 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy women (non-smokers) at least 18 years old who did not have any pregnancy complications, and gave birth to their first child within one month.\nThe study is open to women who are breastfeeding or formula feeding.\n\nExclusion Criteria:\n\nSmoker,\nhad twins or triples,\nhad any major complication of pregnancy(example,\ngestational diabetes);\nhave kidney, liver, hormonal, stomach, intestine,lung, heart or blood disease. This also includes high blood pressure;\nuse prescription or over-the-counter medicine or herbal drinks or pills.\nHistory of depression, anxiety, disordered eating, other psychological problems, alcoholism or other substance abuse.\nSeverely claustrophobic.\nHaving a strong fear of needles and/or do not feel you can have blood drawn every 30 minutes from a plastic catheter.\nAre not able to or willing to fully participate in the study, and are pregnant, anemic or have a thyroid problem.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"Female",
          "MinimumAge":"18 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Dawine E. Larson-Meyer, Phd, RD",
                "OverallOfficialAffiliation":"University of Wyoming",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Nutritional and Exercise Lab University of Wyoming",
                "LocationCity":"Laramie",
                "LocationState":"Wyoming",
                "LocationZip":"82071",
                "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":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}