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

NCT01852721 | Completed

• 3 other identifiers: 2009-213 A1MOP 845682007-180
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Diet adherence

  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.

Secondary Outcomes (8)

• Dietary intakes

  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

  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

  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

  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

  At baseline (t=0).

Study Arms (2)

Men and Mediterranean diet

EXPERIMENTAL

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

Women and Mediterranean diet

EXPERIMENTAL

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

Interventions

Experimental: Men and Mediterranean diet 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.

Men and Mediterranean diet

Experimental: Women and Mediterranean diet BEHAVIORAL

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

Women and Mediterranean diet

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Triglycerides ≥ 1.7 mM;
• Fasting glucose between 6.1 and 6.9 mM;
• Blood pressure concentrations ≥ 130 / 85 mm Hg;
• Waist circumference \> 94 cm in men and \> 80 cm in women

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 25416917 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Multiple Endocrine Neoplasia Type 1; Feeding Behavior

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Simone Lemieux, Ph.D., Dt.P

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 14, 2013
• Study Start: March 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

CA (1)