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

5 de setembro de 2013 atualizado por: Simone Lemieux, Laval University

Gender Differences in Response to the Mediterranean Diet-Part 2

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

123

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • Quebec
      • Québec, Quebec, Canadá, G1V 0A6
        • Institute of Nutraceuticals and Functional Foods (INAF), Laval University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

25 anos a 50 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Experimental: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Diet adherence
Prazo: 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.
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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Dietary intakes
Prazo: 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.
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.
Eating behaviors
Prazo: 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.
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 and metabolic parameters
Prazo: 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.
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.
Physical activity level
Prazo: 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).
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.
Global motivational variables
Prazo: At baseline (t=0).
Self-Determination Scale. Basic Psychological Needs Scale.
At baseline (t=0).
Motivational variables in a nutrition context
Prazo: 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.
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.
Quality of life
Prazo: 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.
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.
Health-Care Climate
Prazo: After the end of the 12-week intervention (t=3 mo).
Health-Care Climate Questionnaire.
After the end of the 12-week intervention (t=3 mo).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Laval University

Colaboradores

Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2010

Conclusão Primária (Real)

1 de novembro de 2012

Conclusão do estudo (Real)

1 de novembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

9 de maio de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de maio de 2013

Primeira postagem (Estimativa)

14 de maio de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

6 de setembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de setembro de 2013

Última verificação

1 de setembro de 2013

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2009-213 A1
  • MOP 84568 (Número de outro subsídio/financiamento: Canadian Institutes of Health Research (MOP 84568))
  • 2007-180 (Número de outro subsídio/financiamento: Heart and Stroke Foundation of Quebec (2007-180))

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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Ensaios clínicos em Experimental: Men and Mediterranean diet

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