nctId: NCT06380218 id: 2023-A00249-36 briefTitle: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE) acronym: SAFE overallStatus: RECRUITING date: 2023-07-11 date: 2025-03-01 date: 2025-08-01 date: 2024-04-23 date: 2024-04-23 name: Institut Pasteur de Lille class: OTHER 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. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 50 type: ESTIMATED name: Nutrional and physical activity program 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" measure: Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" 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" measure: Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program measure: Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" measure: Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine" 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" measure: Satisfaction of Primevere products sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NutrInvest - Institut Pasteur de Lille status: RECRUITING city: Lille state: Nord zip: 59019 country: France name: Coralie Berthier, PhD role: CONTACT phone: 0320877333 phoneExt: 0033 email: coralie.berthier@pasteur-lille.fr name: Bérengère Legendre role: CONTACT phone: 0320877346 phoneExt: 0033 email: berengere.legendre@pasteur-lille.fr name: Jean-Michel Lecerf, MD role: PRINCIPAL_INVESTIGATOR lat: 50.63297 lon: 3.05858 hasResults: False