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

Institut Pasteur de Lille50 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Nutrional and physical activity programBEHAVIORAL

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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

NutrInvest - Institut Pasteur de Lille

Lille, Nord, France

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: At 3 months after the coaching session

Secondary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Central Contacts

Coralie BERTHIER, PhD

CONTACT

0320877333 coralie.berthier@pasteur-lille.fr

Jean-Michel LECERF, MD

CONTACT

0320877771 jean-michel.lecerf@pasteur-lille.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: On the last coaching session - 10 weeks