protocolSection identificationModule nctId: NCT06309342, orgStudyIdInfo id: VGRFOU-278257, briefTitle: Prevention of Lifestyle-related Disorders Based on Functional Examinations, acronym: PREVFUNKTION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Lena Bornhoft, class: OTHER, collaborators name: Vastra Gotaland Region, collaborators name: Göteborg University, descriptionModule briefSummary: The goal of this randomised controlled trial is to examine the effects of functional examinations and feedback/support on healthy 40-year-olds. The main questions it aims to answer are: • Does feedback and motivational interviewing after testing physical function motivate inactive middle-aged people to increase their physical activity level? • Does the intervention lead to health benefits over time - less pain, better function, higher health-related quality of life, fewer risk factors for lifestyle-related illness? Participants will: • undergo medical and functional health examinations, • their physical activity level will be measured, • receive feedback and advice based on both parts of the examinations, • receive a functional profile, • be supported in goalsetting for lifestyle changes. Researchers will compare with a control group who, after the examinations, receive feedback only from the medical examination to see if participants become more physically active, achieve better function, become more motivated to make lifestyle changes, reduce risk factors for lifestyle-related illness, achieve health benefits and better health-related quality of life., conditionsModule conditions: Lifestyle-related Condition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Initial examinations and data collection are made before randomisation. Randomisation then leads to the two groups of participants receiving different amounts of feedback and support. Follow-up examinations and data collection are made after one year in both groups., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Investigators performing the health and function examinations will not be informed about the group to which the participant is allocated. All examinations are performed identically for participants from both groups., whoMasked: INVESTIGATOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: PREVFUNKTION, interventions name: Control, outcomesModule primaryOutcomes measure: Change in objectively measured physical activity, primaryOutcomes measure: Change in objectively measured sedentary behaviour, secondaryOutcomes measure: Change in cardiovascular fitness, secondaryOutcomes measure: Change in motivation level, secondaryOutcomes measure: Proportion achieved goals, secondaryOutcomes measure: Change in fitness level, secondaryOutcomes measure: Change in strength upper extremity, secondaryOutcomes measure: Change in strength lower extremity, secondaryOutcomes measure: Change in strength trunk muscles, secondaryOutcomes measure: Change in balance, secondaryOutcomes measure: Change in mobility, secondaryOutcomes measure: Change in posture, secondaryOutcomes measure: Change in weight measures, secondaryOutcomes measure: Change in pain, secondaryOutcomes measure: Change in physical activity, secondaryOutcomes measure: Change in handgrip strength, secondaryOutcomes measure: Change in biceps strength, secondaryOutcomes measure: Change in leg strength, secondaryOutcomes measure: Change in calf strength, secondaryOutcomes measure: Change in ventral trunk strength, secondaryOutcomes measure: Change in dorsal trunk strength, secondaryOutcomes measure: Change in lower trunk strength, secondaryOutcomes measure: Change in static balance - 1, secondaryOutcomes measure: Change in static balance - 2, secondaryOutcomes measure: Change in static balance - 3, secondaryOutcomes measure: Change in dynamic balance, secondaryOutcomes measure: Change in mobility - 1, secondaryOutcomes measure: Change in mobility - 2, secondaryOutcomes measure: Change in mobility - 3, secondaryOutcomes measure: Change in hypermobility score, secondaryOutcomes measure: Change in neck mobility, secondaryOutcomes measure: Change in foot pronation, secondaryOutcomes measure: Change in habitual stance, secondaryOutcomes measure: Change in health-related quality of life assessed with EQ5D index, secondaryOutcomes measure: Change in health-related quality of life assessed with EQ5D VAS, secondaryOutcomes measure: Change in self-reported physical activity assessed with Swedish questionnaire, secondaryOutcomes measure: Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS), secondaryOutcomes measure: Change in self-reported sedentary time, secondaryOutcomes measure: Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire, secondaryOutcomes measure: Change in number of pain locations, secondaryOutcomes measure: Change in proportion smokers, secondaryOutcomes measure: Change in proportion acceptable level blood glucose, secondaryOutcomes measure: Change in proportion acceptable level serum cholesterol, secondaryOutcomes measure: Change in proportion acceptable level triglycerides, secondaryOutcomes measure: Change in proportion acceptable blood pressure, secondaryOutcomes measure: Change in proportion normal body mass index (BMI), secondaryOutcomes measure: Change in proportion acceptable waist circumference, secondaryOutcomes measure: Change in stress symptoms assessed with Stress and Crisis Inventory-93, secondaryOutcomes measure: Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale, secondaryOutcomes measure: Correlation between self-assessed and objectively measured fitness, secondaryOutcomes measure: Correlation between self-assessed and objectively measured fitness - 2, secondaryOutcomes measure: Correlation between self-assessed and objectively measured strength upper extremity, secondaryOutcomes measure: Correlation between self-assessed and objectively measured strength lower extremity, secondaryOutcomes measure: Correlation between self-assessed and objectively measured balance, secondaryOutcomes measure: Correlation between self-assessed and objectively measured physical activity, secondaryOutcomes measure: Correlation between self-assessed and objectively measured physical activity - 2, eligibilityModule sex: ALL, minimumAge: 39 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False