Clinical trial NCT01852721: Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
Official title: Gender Differences in Response to the Mediterranean Diet-Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
First posted: 2013-05-14
Enrollment: 123
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Diet adherence
timeFrame: 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.
Secondary outcomes:
measure: Dietary intakes
timeFrame: 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.
measure: Eating behaviors
timeFrame: 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.
measure: Anthropometric and metabolic parameters
timeFrame: 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.
measure: Physical activity level
timeFrame: 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.
measure: Global motivational variables
timeFrame: At baseline (t=0).
measure: Motivational variables in a nutrition context
timeFrame: 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.
measure: Quality of life
timeFrame: 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.
measure: Health-Care Climate
timeFrame: After the end of the 12-week intervention (t=3 mo).
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institute of Nutraceuticals and Functional Foods (INAF), Laval University
state: Quebec
Study officials:
affiliation: Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
name: Simone Lemieux, Ph.D., Dt.P
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.