Clinical trial NCT06380218: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
Official title: Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: Nutritional and physical activity program
Prevention
Cardiovascular health
Quality of life
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

The nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing :

* Food balance and diversity
* Eating behaviour and representations
* Level of knowledge in nutrition
* Level of physical activity and physical inactivity
* Physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity
* Behavioural barriers and educational levers to improve women's cardiovascular health

Eligibility criteria: Inclusion Criteria:

* BMI \> 25kg/m² and/or with a waist circumference \> 88 cm
* Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids

Exclusion Criteria:

* Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)
* Consuming omega-3 rich food supplements within 3 months of inclusion
* Treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months
* Suffering of eating disorders
* Presenting a medical contraindication to the practice of physical activity
* Having previously participated in a similar prevention program
* Suffering from serious chronic diseases (cancer, serious cardiovascular history, etc.)

Primary outcomes:
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
Secondary outcomes:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
measure: Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program
timeFrame: At 3 months after the coaching session
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
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
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
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
measure: Satisfaction of Primevere products
timeFrame: On the last coaching session - 10 weeks
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: Institut Pasteur de Lille - NutrInvest
name: Jean-Michel Lecerf, MD
role: PRINCIPAL_INVESTIGATOR
References: