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

NCT ID: NCT01852721

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-11-30

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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular diseases; Nutritional intervention program; Self-Determination Theory; Motivational interviewing; Gender differences; Women; Men; Motivation; Dietary intakes; Mediterranean diet; Eating behaviors; Lipid profile

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Men and Mediterranean diet

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.

Group Type: EXPERIMENTAL

Experimental: Men and Mediterranean diet

Intervention Type: BEHAVIORAL

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 and Mediterranean diet

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.

Group Type: EXPERIMENTAL

Experimental: Women and Mediterranean diet

Intervention Type: BEHAVIORAL

Women are assigned to the same intervention than men in order to compare men and women adherence to the Mediterranean diet.

Interventions

Experimental: Men and Mediterranean diet

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.

Intervention Type: BEHAVIORAL

Experimental: Women and Mediterranean diet

Women are assigned to the same intervention than men in order to compare men and women adherence to the Mediterranean diet.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Heart and Stroke Foundation of Canada

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Simone Lemieux

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simone Lemieux, Ph.D., Dt.P

Role: PRINCIPAL_INVESTIGATOR

Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University

Locations

Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Québec, Quebec, Canada

Countries

Canada

References

Leblanc V, Begin C, Hudon AM, Royer MM, Corneau L, Dodin S, Lemieux S. Gender differences in the long-term effects of a nutritional intervention program promoting the Mediterranean diet: changes in dietary intakes, eating behaviors, anthropometric and metabolic variables. Nutr J. 2014 Nov 22;13:107. doi: 10.1186/1475-2891-13-107.

Reference Type: DERIVED

PMID: 25416917 (View on PubMed)

Other Identifiers

MOP 84568

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2007-180

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2009-213 A1

Identifier Type: -

Identifier Source: org_study_id