protocolSection identificationModule nctId: NCT06380218, orgStudyIdInfo id: 2023-A00249-36, briefTitle: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE), acronym: SAFE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-11, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Institut Pasteur de Lille, class: OTHER, descriptionModule briefSummary: The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Nutrional and physical activity program, outcomesModule primaryOutcomes measure: Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program, secondaryOutcomes measure: Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine", secondaryOutcomes measure: Satisfaction of Primevere products, eligibilityModule sex: FEMALE, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NutrInvest - Institut Pasteur de Lille, status: RECRUITING, city: Lille, state: Nord, zip: 59019, country: France, contacts name: Coralie Berthier, PhD, role: CONTACT, phone: 0320877333, phoneExt: 0033, email: coralie.berthier@pasteur-lille.fr, contacts name: Bérengère Legendre, role: CONTACT, phone: 0320877346, phoneExt: 0033, email: berengere.legendre@pasteur-lille.fr, contacts name: Jean-Michel Lecerf, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, hasResults: False