Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
    

Intervention name(s): Experimental: Men and Mediterranean diet; Experimental: Women and Mediterranean diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 12-week nutritional education program will include 3 group sessions with 8-12 participants per group. During the 1st group session, the registered dietitian (RD) will explain the major principles of the Mediterranean diet (MedDiet) and related heath benefits. At week 4, subjects will be invited to a Mediterranean cooking lesson. At week 8, the group session will address barriers and difficulties in adhering to the recommendations. Individual sessions will take place at weeks 1, 5 and 10 in order to evaluate the dietary changes and to select further individualized objectives for increasing the adherence to the MedDiet. The RD will encourage participants to make their own decision about changes while promoting their autonomy and competence. Qualitative 24-h recalls will be performed by telephone at weeks 3, 6, 9 and 12 to reinforce key principles of the MedDiet. No further contact with the RD will be offered during the follow-up period.; Women are assigned to the same intervention than men in order to compare men and women adherence to the Mediterranean diet.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiovascular diseases; Nutritional intervention program; Self-Determination Theory; Motivational interviewing; Gender differences; Women; Men; Motivation; Dietary intakes; Mediterranean diet; Eating behaviors; Lipid profile