Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2

Laval University

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Experimental: Men and Mediterranean diet; Behavioral: Experimental: Women and Mediterranean diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01852721

MOP 84568 (Other Grant/Funding Number)

2009-213 A1

2007-180 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and premenopausal women from de Quebec City metropolitan area.

• Involved in food purchases and/or meal preparation

• Stable body weight (+/- 2.5 kg) for at least 3 months before the beginning of the study

• Slightly elevated LDL-cholesterol concentrations (≥ 3.0 mM) or total cholesterol to HDL-C ratio ≥ 5.0

• At least one of the four following factors of the metabolic syndrome:

  1. Triglycerides ≥ 1.7 mM;
  2. Fasting glucose between 6.1 and 6.9 mM;
  3. Blood pressure concentrations ≥ 130 / 85 mm Hg;
  4. Waist circumference > 94 cm in men and > 80 cm in women

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

Men and Mediterranean diet

Experimental group

Description:

The 12-week nutritional education program will include 3 group sessions with 8-12 participants per group, 3 individual counseling sessions, and 4 telephone interviews. The registered dietitian will encourage participants to make their own decision about dietary changes while promoting their autonomy and competence, and will accept participants' choices, avoiding pressuring them to perform a specific change.

Treatment:

Behavioral: Experimental: Men and Mediterranean diet

Women and Mediterranean diet

Experimental group

Description:

The 12-week nutritional education program will include 3 group sessions with 8-12 participants per group, 3 individual counseling sessions, and 4 telephone interviews. The registered dietitian will encourage participants to make their own decision about dietary changes while promoting their autonomy and competence, and will accept participants' choices, avoiding pressuring them to perform a specific change.

Treatment:

Behavioral: Experimental: Women and Mediterranean diet