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

NCT01852721 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2013-09-06

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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.

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Heart and Stroke Foundation of Canada

    collaborator OTHER
  • Laval University

    lead OTHER

Principal Investigators

  • Simone Lemieux, Ph.D., Dt.P · Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852721 on ClinicalTrials.gov