{ "FullStudy":{ "Rank":217844, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516099", "OrgStudyIdInfo":{ "OrgStudyId":"S53801" }, "Organization":{ "OrgFullName":"Universitaire Ziekenhuizen Leuven", "OrgClass":"OTHER" }, "BriefTitle":"A Structural Approach to Implement the Role of 'Physical Activity Counselors' in Sports and Exercise Promotion", "OfficialTitle":"Pilot Study: A Structural Approach to Implement the Role of 'Physical Activity Counselors' in Sports and Exercise Promotion in Flanders" }, "StatusModule":{ "StatusVerifiedDate":"August 2013", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 12, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 13, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Christophe Delecluse", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Universitaire Ziekenhuizen Leuven" }, "LeadSponsor":{ "LeadSponsorName":"Universitaire Ziekenhuizen Leuven", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Belgian Government", "CollaboratorClass":"OTHER_GOV" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The primary aim of this study is to investigate how a physical activity counselor can offer an added value in the sports and exercise promotion in Flanders. The investigators will explore if the physical activity counselor, in collaboration with the setting of general practitioners and social-cultural associations, can refer sedentary people and persons who are active in a non-organized context, into systematic participation in sports and/or exercise. Additionally, the investigators want to determine if the physical activity counselor will succeed in referring the target population to the local supervised and structured sports and exercise activities.", "DetailedDescription":"Being regularly physically active is a basic component of a healthy lifestyle. However, a large amount of the Flemish population does not reach the prescribed guidelines and cannot enjoy the health benefits related to an active lifestyle. One part of the population is physically active but makes no use of the existing, structured and supervised exercise and sports programs. Therefore the chance on lifetime participation in sports and exercise is quite low in this group. Another group consists of sedentary people that does not participate in any exercise or sports activity at all.\n\nA physical activity counselor can possibly deliver a crucial service for the above mentioned groups. He/she can design an individualized sports- or exercise approach and program. In the short term, the physical activity counselor can guide the participant into his first success experiences regarding exercise and sports. In the long term, the chance of remaining physically active will increase by improving the understanding and the self-confidence of these participants.\n\nHowever it is questioned how the physical activity counselor can reach these target groups in an efficient way, as the traditional sports and exercise promotion seems to have no impact on these persons. A first alternative may be the setting of the general practitioners. The general practitioner is, as a care provider in primary health care, in a good position to refer sedentary people or those who are active in a non-organized context to a physical activity counselor for 'minimal' coaching. A second alternative can be the setting of the social-cultural associations (e.g. seniors association, women association, neighborhood actions, …). The social context and the local networks in these associations facilitate the proper forms of motivation to exercise with other people and to adapt to a healthy lifestyle." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Sedentary Lifestyle" ] }, "KeywordList":{ "Keyword":[ "Physical activity counselor", "Active and healthy lifestyle", "General Practitioner", "Social-cultural Organization" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"110", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"General Practitioners", "ArmGroupType":"Experimental", "ArmGroupDescription":"The general practitioner can refer his patients to a physical activity counselor for an individual coaching. The investigators aim for a brief coaching period of 10 weeks with the objective that the people continue their active lifestyle afterwards.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: General Practitioners" ] } },{ "ArmGroupLabel":"Social-cultural organizations", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the social-cultural organization, members can sign in for group sessions led by the physical activity counselor. The investigators aim for a brief coaching period of 10 weeks with the objective that the people continue their active lifestyle afterwards.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Social-cultural organizations" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"General Practitioners", "InterventionDescription":"The general practitioner can refer his patients to a physical activity counselor for an individual coaching (intake session with development of program and pretesting, follow up by e-mail or phone (max 4x), personal contact moments (max 3x) and exit session with evaluation and posttesting).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "General Practitioners" ] } },{ "InterventionType":"Other", "InterventionName":"Social-cultural organizations", "InterventionDescription":"In the social-cultural organization, members can sign in for group sessions led by the physical activity counselor (intake session with development of program and pretesting, follow up by email or letters (max 4x), personal contact moments (max 4x) and exit session with evaluation and posttesting).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Social-cultural organizations" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in health-related anthropometric measures", "PrimaryOutcomeDescription":"Length, Weight, Abdominal circumference", "PrimaryOutcomeTimeFrame":"baseline, 10 weeks, 6 months" },{ "PrimaryOutcomeMeasure":"Change in objective measure of degree of physical activity", "PrimaryOutcomeDescription":"Sensewear: little accelerometer that will be carried on the upper arm during several days and consequently registrates the amount of physical activity during this period.", "PrimaryOutcomeTimeFrame":"Baseline, 10 weeks, 6 months" },{ "PrimaryOutcomeMeasure":"Change in mental well-being", "PrimaryOutcomeDescription":"Standardized questionnaire", "PrimaryOutcomeTimeFrame":"Baseline, 10 weeks, 6 months" },{ "PrimaryOutcomeMeasure":"Change in motivation to be physically active", "PrimaryOutcomeDescription":"Standardized questionnaire", "PrimaryOutcomeTimeFrame":"Baseline, 10 weeks, 6 months" },{ "PrimaryOutcomeMeasure":"Change in participation in local structured sports and exercise", "PrimaryOutcomeDescription":"Standardized questionnaire", "PrimaryOutcomeTimeFrame":"Baseline, 10 weeks, 6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nBetween 18-75 years of age\nAble to walk\n\nExclusion Criteria:\n\nSevere cardial disease", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Christophe Delecluse, PhD, Dr", "OverallOfficialAffiliation":"Faculty of Kinesiology and Rehabilitation Sciences", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Katholieke Universiteit Leuven - Faculty of Kinesiology and Rehabilitation Sciences", "LocationCity":"Leuven", "LocationState":"Vlaams Brabant", "LocationZip":"3000", "LocationCountry":"Belgium" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" } } } } }