nctId: NCT06309342 id: VGRFOU-278257 briefTitle: Prevention of Lifestyle-related Disorders Based on Functional Examinations acronym: PREVFUNKTION overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: Lena Bornhoft class: OTHER name: Vastra Gotaland Region name: Göteborg University 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. conditions: Lifestyle-related Condition studyType: INTERVENTIONAL phases: NA 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 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 count: 250 type: ESTIMATED name: PREVFUNKTION name: Control measure: Change in objectively measured physical activity measure: Change in objectively measured sedentary behaviour measure: Change in cardiovascular fitness measure: Change in motivation level measure: Proportion achieved goals measure: Change in fitness level measure: Change in strength upper extremity measure: Change in strength lower extremity measure: Change in strength trunk muscles measure: Change in balance measure: Change in mobility measure: Change in posture measure: Change in weight measures measure: Change in pain measure: Change in physical activity measure: Change in handgrip strength measure: Change in biceps strength measure: Change in leg strength measure: Change in calf strength measure: Change in ventral trunk strength measure: Change in dorsal trunk strength measure: Change in lower trunk strength measure: Change in static balance - 1 measure: Change in static balance - 2 measure: Change in static balance - 3 measure: Change in dynamic balance measure: Change in mobility - 1 measure: Change in mobility - 2 measure: Change in mobility - 3 measure: Change in hypermobility score measure: Change in neck mobility measure: Change in foot pronation measure: Change in habitual stance measure: Change in health-related quality of life assessed with EQ5D index measure: Change in health-related quality of life assessed with EQ5D VAS measure: Change in self-reported physical activity assessed with Swedish questionnaire measure: Change in self-reported physical activity assessed with Saltin Grimby Physical Activity Level Scale (SGPALS) measure: Change in self-reported sedentary time measure: Change in risk for chronic pain and sickness absence assessed with Örebro Musculoskeletal Pain Screening Questionnaire measure: Change in number of pain locations measure: Change in proportion smokers measure: Change in proportion acceptable level blood glucose measure: Change in proportion acceptable level serum cholesterol measure: Change in proportion acceptable level triglycerides measure: Change in proportion acceptable blood pressure measure: Change in proportion normal body mass index (BMI) measure: Change in proportion acceptable waist circumference measure: Change in stress symptoms assessed with Stress and Crisis Inventory-93 measure: Change in depression and anxiety symptoms assessed with Hospital Anxiety and Depression Scale measure: Correlation between self-assessed and objectively measured fitness measure: Correlation between self-assessed and objectively measured fitness - 2 measure: Correlation between self-assessed and objectively measured strength upper extremity measure: Correlation between self-assessed and objectively measured strength lower extremity measure: Correlation between self-assessed and objectively measured balance measure: Correlation between self-assessed and objectively measured physical activity measure: Correlation between self-assessed and objectively measured physical activity - 2 sex: ALL minimumAge: 39 Years maximumAge: 40 Years stdAges: ADULT hasResults: False