Trial record 2 of 1500 for:    nutrition AND (woman OR women OR female)

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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
Simone Lemieux, Laval University
ClinicalTrials.gov Identifier:
NCT01852721
First received: May 9, 2013
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Behavioral: Experimental: Men and Mediterranean diet
Behavioral: Experimental: Women and Mediterranean diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Gender Differences in Response to the Mediterranean Diet-Part 2

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Diet adherence [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Dietary intakes [ Time Frame: 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. ] [ Designated as safety issue: No ]

    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.


  • Eating behaviors [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Cognitive dietary restraint, disinhibition, and susceptibility to hunger.

  • Anthropometric and metabolic parameters [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.

  • Physical activity level [ Time Frame: 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. ] [ Designated as safety issue: No ]
    A validated 3-day physical activity record (two weekdays and one weekend day).

  • Global motivational variables [ Time Frame: At baseline (t=0). ] [ Designated as safety issue: No ]
    Self-Determination Scale. Basic Psychological Needs Scale.

  • Motivational variables in a nutrition context [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Regulation of Eating Behaviors Scale.

  • Quality of life [ Time Frame: 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. ] [ Designated as safety issue: No ]
    SF-36.

  • Health-Care Climate [ Time Frame: After the end of the 12-week intervention (t=3 mo). ] [ Designated as safety issue: No ]
    Health-Care Climate Questionnaire.


Enrollment: 123
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01852721

Locations
Canada, Quebec
Institute of Nutraceuticals and Functional Foods (INAF), Laval University
Québec, Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Investigators
Principal Investigator: Simone Lemieux, Ph.D., Dt.P Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
  More Information

No publications provided

Responsible Party: Simone Lemieux, Professor, Laval University
ClinicalTrials.gov Identifier: NCT01852721     History of Changes
Other Study ID Numbers: 2009-213 A1, MOP 84568, 2007-180
Study First Received: May 9, 2013
Last Updated: September 5, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
Women
Mediterranean diet
Cardiovascular diseases
Nutritional intervention program
Self-Determination Theory
Motivational interviewing
Gender differences
Men
Motivation
Dietary intakes
Eating behaviors
Lipid profile

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014