Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06380218
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, '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"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Quality of Life Questionnaire Short Form-36 validated by World Health Organization (WHO)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Lifestyle Questionnaire : consumption of alcohol and tobacco and quality of sleeping'}, {'measure': 'Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Visual analogue scales on changes in well-being ranging from 10 (best) to 0 (worst)'}, {'measure': 'Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Cohen Questionnaire'}, {'measure': 'Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille'}, {'measure': 'Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Behavioural questionnaire and food representation proposed by the Institut Pasteur de Lille'}, {'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"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Food knowledge Questionnaire (10 points) Physical Activity knowledge Questionnaire (10 points)'}, {'measure': 'Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Prochaska Scale: Motivation to Change raging from "I don\'t want to" to "I will continue to do so" Identifying Barriers and Levers for Behaviour Change Related to Physical Activity Practice and food'}, {'measure': 'Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Ricci \\& Gagnon questionnaire (level of physical activity and sedentary lifestyle)'}, {'measure': 'Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': "The using test is :\n\n• Ruffier Dickson test (recovery capacity) - to calculate an index of the heart's ability to adapt to physical activity with the heart rate measurement\n\nThis index is measured like that :\n\n\\< or = 0 : excellent 0 to 2 : very good 2 to 4 : good 4 to 6 : average 6 to 8 : weak 8 to 10 : very weak \\> 10 : poor adaptation"}, {'measure': 'Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'The using test is :\n\n• Unipodal balance (static balance) Measured in seconds'}, {'measure': 'Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'The using test is :\n\n• Flexible trunk and posterior chain of lower limbs (flexibility) Measured by index ranging from 5 (the palms of the hands touch the ground) to 1 (the fingertips reach the lower shins)'}, {'measure': 'Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'The using test is :\n\n• Grip force (handgrip strength) Measured in kilograms'}, {'measure': 'Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'The using test is :\n\n• Sitting/standing on chair (lower limb strength) Measured in seconds'}, {'measure': 'Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'The using test is :\n\n• 6 minutes walk test (endurance) Measured in meters'}, {'measure': 'Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Blood samples will be collected to analyse: Total cholesterol, HDL, LDL, triglycerides and erythrocyte rate ω3 and ratio ω6/ω3'}, {'measure': 'Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Blood samples will be collected to analyse fasting blood glucose'}, {'measure': 'Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Cardiovascular risk will be collected Cardiovascular Risk Assessment SCORE. The major variables are sexe, age, smoking status or not, blood pressure and total cholesterol'}, {'measure': 'Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Height, (m) weight (kg) to calculate BMI'}, {'measure': 'Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Waist circumference (cm)'}, {'measure': 'Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Body composition by impedance measurement: % fat mass, % lean mass'}, {'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"', 'timeFrame': 'At 3 months after the coaching session', 'description': 'Systolic and diastolic blood pressure to calculate blood pressure'}, {'measure': 'Satisfaction of Primevere products', 'timeFrame': 'On the last coaching session - 10 weeks', 'description': 'Measured by comprehension and utility of Primevere tools questionnaire and perception of Primevere Margarine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutritional and physical activity program', 'Prevention', 'Cardiovascular health', 'Quality of life'], 'conditions': ['Healthy Volunteers']}, '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.', 'detailedDescription': '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 aged 40 to 65 with cardiovascular risk 3 months after 10 group coaching sessions.\n\nThe nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing :\n\n* Food balance and diversity\n* Eating behaviour and representations\n* Level of knowledge in nutrition\n* Level of physical activity and physical inactivity\n* Physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity\n* Behavioural barriers and educational levers to improve women\'s cardiovascular health'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 25kg/m² and/or with a waist circumference \\> 88 cm\n* Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids\n\nExclusion Criteria:\n\n* Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)\n* Consuming omega-3 rich food supplements within 3 months of inclusion\n* Treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months\n* Suffering of eating disorders\n* Presenting a medical contraindication to the practice of physical activity\n* Having previously participated in a similar prevention program\n* Suffering from serious chronic diseases (cancer, serious cardiovascular history, etc.)'}, 'identificationModule': {'nctId': 'NCT06380218', 'acronym': 'SAFE', 'briefTitle': "Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)", 'organization': {'class': 'OTHER', 'fullName': 'Institut Pasteur de Lille'}, 'officialTitle': "Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)", 'orgStudyIdInfo': {'id': '2023-A00249-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrional and physical activity program', 'description': '10 collective combined workshops of nutrition and physical activity = 1 per week during 10 weeks associated to margarine consumption', 'interventionNames': ['Behavioral: Nutrional and physical activity program']}], 'interventions': [{'name': 'Nutrional and physical activity program', 'type': 'BEHAVIORAL', 'description': 'Nutritional prevention and physical activity workshops associated with a substitution of saturated and/or trans fatty acids by cis-unsaturated acids via the consumption of Primevère margarine to influence lifestyle habits, quality of life and improvement of the lipid profile of women with cardiovascular risk', 'armGroupLabels': ['Nutrional and physical activity program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59019', 'city': 'Lille', 'state': 'Nord', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Coralie Berthier, PhD', 'role': 'CONTACT', 'email': 'coralie.berthier@pasteur-lille.fr', 'phone': '0320877333', 'phoneExt': '0033'}, {'name': 'Bérengère Legendre', 'role': 'CONTACT', 'email': 'berengere.legendre@pasteur-lille.fr', 'phone': '0320877346', 'phoneExt': '0033'}, {'name': 'Jean-Michel Lecerf, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NutrInvest - Institut Pasteur de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Coralie BERTHIER, PhD', 'role': 'CONTACT', 'email': 'coralie.berthier@pasteur-lille.fr', 'phone': '0320877333', 'phoneExt': '0033'}, {'name': 'Jean-Michel LECERF, MD', 'role': 'CONTACT', 'email': 'jean-michel.lecerf@pasteur-lille.fr', 'phone': '0320877771', 'phoneExt': '0033'}], 'overallOfficials': [{'name': 'Jean-Michel Lecerf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Pasteur de Lille - NutrInvest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Invesigator', 'investigatorFullName': 'Jean-Michel Lecerf', 'investigatorAffiliation': 'Institut Pasteur de Lille'}}}}