Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)

Pasteur Institute of Lille (IPL)

Status: Enrolling

Conditions: Healthy Volunteers

Treatments: Behavioral: Nutrional and physical activity program

Study type: Interventional

Funder types: Other

Identifiers

NCT06380218

2023-A00249-36

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nutrional and physical activity program

Experimental group

Description:

10 collective combined workshops of nutrition and physical activity = 1 per week during 10 weeks associated to margarine consumption

Treatment:

Behavioral: Nutrional and physical activity program