Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
- Conditions
- Cardiovascular Diseases
- Registration Number
- NCT01852721
- Lead Sponsor
- Laval University
- Brief Summary
The purpose of this study is to document differences between men and women (referred here as gender differences) in diet adherence and in changes in specific dietary intakes and energy density in response to a 12-week nutritional education program promoting the Mediterranean diet in both the short term (immediately after the end of the intervention) and longer term (3 and 6 months after the end of the intervention). The investigators hypothesize that both in the short and the longer term, women will have a better adherence to recommendations promoting the Mediterranean diet than men namely because of higher self-determination.
- Detailed Description
Among the few studies that have addressed gender differences in response to a nutritional program promoting the Mediterranean diet, none has used a theoretical model of dietary adherence. Accordingly, the Self-Determination Theory suggests that the different behavioral types of regulation are associated with one of the three forms of motivation which are intrinsic motivation, extrinsic motivation and amotivation. The use of the Self-Determination Theory as a theoretical model of adherence will provide original data on the potential contribution of self-determination to gender differences in adherence to an intervention promoting the Mediterranean diet. The purpose of this study is to document gender differences between men and women in diet adherence and in changes in specific dietary intakes and energy density in response to a 12-week nutritional education program promoting the Mediterranean diet in both the short term (immediately after the end of the intervention) and longer term (3 and 6 months after the end of the intervention). Considering that previous studies have shown that women were more likely than men to take action to improve eating habits, rated higher their knowledge of nutrition than men and also indicated that they read product labels more frequently than men, we hypothesize that both in the short and the longer term, women will have a better adherence to recommendations promoting the Mediterranean diet than men namely because of higher self-determination. Data will be collected before and after the 12-week nutritional education program, as well as 3 and 6 months after the end of the intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
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Men and premenopausal women from de Quebec City metropolitan area.
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Involved in food purchases and/or meal preparation
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Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study
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Slightly elevated LDL-cholesterol concentrations (≥ 3.0 mM) or total cholesterol to HDL-C ratio ≥ 5.0
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At least one of the four following factors of the metabolic syndrome:
- Triglycerides ≥ 1.7 mM;
- Fasting glucose between 6.1 and 6.9 mM;
- Blood pressure concentrations ≥ 130 / 85 mm Hg;
- Waist circumference > 94 cm in men and > 80 cm in women
- Smokers
- Alcoholism problem
- Pregnancy
- Cardiovascular and endocrinal diseases
- Medication that could affect dependent variables measured (namely lipid-lowering, hypoglycemic, insulin sensitizers and antihypertensive medication)
- Food allergies/aversions
- Mediterranean score > 29
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diet adherence At baseline (t=0) and immediately after the 12-week intervention (t=3 mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. A Mediterranean score will be used to measure diet adherence. As described by Dansinger et al, we will use a 10-point score to describe the degree to which each subject achieves the specified dietary target vs baseline intakes. The target would be a perfect Mediterranean score of 44. For example, a subject with a Med Score of 20 at baseline and of 30 at t=12 weeks will therefore have an adherence score at t=12 weeks of : (20 - 30) / (20 - 44) =0.42 or 4.2 on a scale of 10.
- Secondary Outcome Measures
Name Time Method Dietary intakes At baseline (t=0) and immediately after the 12-week intervention (t=3mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. A 30-min Food Frequency Questionnaire (FFQ) will be administered face-to-face by a Registered Dietitian. A Mediterranean score will be derived from the FFQ. The Mediterranean score could therefore vary between 0 and 44 points.
A 3-day weighed food record will be completed in order to derive a precise measurement of energy density.Eating behaviors At baseline (t=0) and immediately after the 12-week intervention (t=3 mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. Cognitive dietary restraint, disinhibition, and susceptibility to hunger.
Anthropometric and metabolic parameters At baseline (t=0) and immediately after the 12-week intervention (t=3 mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. Anthropometric variables (height, weight, waist and hip circumferences) according to standardized procedures and basic lipid profile, fasting glycemia and insulinemia as well as blood pressure will be measured.
Physical activity level At baseline (t=0) and immediately after the 12-week intervention (t=3 mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. A validated 3-day physical activity record (two weekdays and one weekend day).
Global motivational variables At baseline (t=0). Self-Determination Scale. Basic Psychological Needs Scale.
Motivational variables in a nutrition context At baseline (t=0) and immediately after the 12-week intervention (t=3 mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. Regulation of Eating Behaviors Scale.
Quality of life At baseline (t=0) and immediately after the 12-week intervention (t=3 mo) as well as 3 (t=6 mo) and 6 months (t= 9 mo) after the end of the intervention. SF-36.
Health-Care Climate After the end of the 12-week intervention (t=3 mo). Health-Care Climate Questionnaire.
Trial Locations
- Locations (1)
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
🇨🇦Québec, Quebec, Canada