protocolSection identificationModule nctId: NCT06379802, orgStudyIdInfo id: 2023-00546-01, briefTitle: Lifestyle Intervention With Physical Activity and Diet, acronym: LI-PAD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: The aim of this pilot randomized controlled trial LI-PAD is to identify whether a 6-month intervention approach to individually optimize lifestyle behavior, physical activity, and diet, is feasible and leads to larger improvements in body weight, cardiovascular disease risk factors, and health-related quality of life compared to simple written lifestyle advice, in individuals with overweight or obesity.The intervention group will be offered individual support for lifestyle behavioral change (precision health) and the control group will be offered written lifestyle advice, following national recommendations. In total, 60 population-based participants and 60 controls from the Gothenburg area, aged 45-65 years, will be recruited., conditionsModule conditions: Overweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Individualized physical activity and diet, outcomesModule primaryOutcomes measure: Change in body weight 1, primaryOutcomes measure: Change in body weight 2, primaryOutcomes measure: Change in body weight 3, primaryOutcomes measure: Change in body weight 4, secondaryOutcomes measure: Length in cm, secondaryOutcomes measure: Weight in kilograms, secondaryOutcomes measure: Cardiovascular disease risk factor change - Body Mass Index (BMI), secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 1, secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-to-hip ratio 2, secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-to-hip-ratio 3, secondaryOutcomes measure: Cardiovascular disease risk factor change - Waist-hip-ratio 4, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 1, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 2, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 3, secondaryOutcomes measure: Cardiovascular disease risk factor change - Blood pressure 4, secondaryOutcomes measure: Cardiovascular disease risk factor change - Long-term blood glucose control using glycated haemoglobin (HbA1c), secondaryOutcomes measure: Cardiovascular disease risk factor change - Serum (total) Cholesterol (S-Cholesterol), secondaryOutcomes measure: Cardiovascular disease risk factor change - High density lipoprotein (HDL), secondaryOutcomes measure: Cardiovascular disease risk factor change - Low densitiy lipoprotein (LDL), secondaryOutcomes measure: Cardiovascular disease risk factor change - Triglycerides, secondaryOutcomes measure: Cardiovascular disease risk factor change - Aerobic fitness (predicted V02 max), secondaryOutcomes measure: Cardiovascular disease risk factor change - Physical activity level, secondaryOutcomes measure: Change in functional lower extremity muscle strength, secondaryOutcomes measure: Change in upper extremity muscle strength - Hand grip strength, secondaryOutcomes measure: Change in muscle strength - Shoulder flexion, secondaryOutcomes measure: Change in muscle strength - Ankle Plantar, secondaryOutcomes measure: Cardiovascular disease risk factor change - Healthy food intake, secondaryOutcomes measure: Change in resting energy expenditure 1, secondaryOutcomes measure: Change in resting energy expenditure 2, secondaryOutcomes measure: Change in resting energy expenditure 3, secondaryOutcomes measure: Change in resting energy expenditure 4, secondaryOutcomes measure: Change in respiratory quotient 1, secondaryOutcomes measure: Change in respiratory quotient 2, secondaryOutcomes measure: Change in respiratory quotient 3, secondaryOutcomes measure: Change in respiratory quotient 4, secondaryOutcomes measure: Change in health-related quality of life - Proportions of problems in five dimensions, secondaryOutcomes measure: Change in health-related quality of life - Index score, secondaryOutcomes measure: Change in health-related quality of life - Visual analog score of present health status, secondaryOutcomes measure: Change in health-related quality of life - Health status categories, secondaryOutcomes measure: Change in self-reported physical activity level, secondaryOutcomes measure: Change in exposure pattern to the food environment, secondaryOutcomes measure: Change in exposure pattern to the built environment, secondaryOutcomes measure: Process evaluation measure 1 - Extent to which intervention was implemented as planned, secondaryOutcomes measure: Process evaluation measure 2 - Number of sessions of each intervention component delivered, secondaryOutcomes measure: Process evaluation measure 3 - Number of sessions of each intervention component received, secondaryOutcomes measure: Process evaluation measure 4 - Satisfaction with individual lifestyle counselling, secondaryOutcomes measure: Process evaluation measure 5 - Satisfaction with the lifestyle school, secondaryOutcomes measure: Process evaluation measure 6A - Perceived facilitators, secondaryOutcomes measure: Process evaluation measure 6B - Perceived barriers, secondaryOutcomes measure: Process evaluation measure 7 - Reach, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre for lifestyle intervention, status: RECRUITING, city: Gothenburg, country: Sweden, contacts name: Mats Börjesson, Prof., role: CONTACT, email: mats.borjesson@gu.se, contacts name: Carina Persson, Ass. prof., role: CONTACT, email: carina.perssson@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-12, uploadDate: 2024-04-12T10:31, filename: Prot_000.pdf, size: 411005, hasResults: False