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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Behavioral: Nutrional and physical activity program

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Coralie Berthier, PhD; Phone Number: 0033 0320877333; Email: coralie.berthier@pasteur-lille.fr
• Study Contact Backup: Name: Jean-Michel LECERF, MD; Phone Number: 0033 0320877771; Email: jean-michel.lecerf@pasteur-lille.fr

Study Locations

• France
  • Nord
    • Lille, Nord, France, 59019
      • Recruiting
      • NutrInvest - Institut Pasteur de Lille
      • Contact: Coralie Berthier, PhD; Phone Number: 0033 0320877333; Email: coralie.berthier@pasteur-lille.fr
      • Contact: Bérengère Legendre; Phone Number: 0033 0320877346; Email: berengere.legendre@pasteur-lille.fr
      • Principal Investigator: Jean-Michel Lecerf, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutrional and physical activity program; 10 collective combined workshops of nutrition and physical activity = 1 per week during 10 weeks associated to margarine consumption	Behavioral: Nutrional and physical activity program; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	Quality of Life Questionnaire Short Form-36 validated by World Health Organization (WHO)	At 3 months after the coaching session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Lifestyle Questionnaire : consumption of alcohol and tobacco and quality of sleeping	At 3 months after the coaching session
Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Visual analogue scales on changes in well-being ranging from 10 (best) to 0 (worst)	At 3 months after the coaching session
Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Cohen Questionnaire	At 3 months after the coaching session
Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Balance and dietary diversity questionnaire proposed by the Institut Pasteur de Lille	At 3 months after the coaching session
Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Behavioural questionnaire and food representation proposed by the Institut Pasteur de Lille	At 3 months after the coaching session
Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Food knowledge Questionnaire (10 points) Physical Activity knowledge Questionnaire (10 points)	At 3 months after the coaching session
Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	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	At 3 months after the coaching session
Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Ricci & Gagnon questionnaire (level of physical activity and sedentary lifestyle)	At 3 months after the coaching session
Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	The using test is : • Ruffier Dickson test (recovery capacity) - to calculate an index of the heart's ability to adapt to physical activity with the heart rate measurement This index is measured like that : < 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	At 3 months after the coaching session
Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	The using test is : • Unipodal balance (static balance) Measured in seconds	At 3 months after the coaching session
Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	The using test is : • 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)	At 3 months after the coaching session
Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	The using test is : • Grip force (handgrip strength) Measured in kilograms	At 3 months after the coaching session
Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	The using test is : • Sitting/standing on chair (lower limb strength) Measured in seconds	At 3 months after the coaching session
Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	The using test is : • 6 minutes walk test (endurance) Measured in meters	At 3 months after the coaching session
Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Blood samples will be collected to analyse: Total cholesterol, HDL, LDL, triglycerides and erythrocyte rate ω3 and ratio ω6/ω3	At 3 months after the coaching session
Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Blood samples will be collected to analyse fasting blood glucose	At 3 months after the coaching session
Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program	Cardiovascular risk will be collected Cardiovascular Risk Assessment SCORE. The major variables are sexe, age, smoking status or not, blood pressure and total cholesterol	At 3 months after the coaching session
Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Height, (m) weight (kg) to calculate BMI	At 3 months after the coaching session
Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Waist circumference (cm)	At 3 months after the coaching session
Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Body composition by impedance measurement: % fat mass, % lean mass	At 3 months after the coaching session
Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"	Systolic and diastolic blood pressure to calculate blood pressure	At 3 months after the coaching session
Satisfaction of Primevere products	Measured by comprehension and utility of Primevere tools questionnaire and perception of Primevere Margarine	On the last coaching session - 10 weeks

Collaborators and Investigators

• Sponsor: Institut Pasteur de Lille
• Investigators: Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille - NutrInvest

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Prevention; Cardiovascular health; Nutritional and physical activity program
• Other Study ID Numbers: 2023-A00249-36

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No