Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
5. september 2013 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
123
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Quebec
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Québec, Quebec, Canada, G1V 0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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:
- 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
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Eksperimentel: 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.
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Women are assigned to the same intervention than men in order to compare men and women adherence to the Mediterranean diet.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Diet adherence
Tidsramme: 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.
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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.
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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.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Dietary intakes
Tidsramme: 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.
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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.
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Eating behaviors
Tidsramme: 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.
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Cognitive dietary restraint, disinhibition, and susceptibility to hunger.
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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.
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Anthropometric and metabolic parameters
Tidsramme: 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.
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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.
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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.
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Physical activity level
Tidsramme: 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.
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A validated 3-day physical activity record (two weekdays and one weekend day).
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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.
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Global motivational variables
Tidsramme: At baseline (t=0).
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Self-Determination Scale.
Basic Psychological Needs Scale.
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At baseline (t=0).
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Motivational variables in a nutrition context
Tidsramme: 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.
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Regulation of Eating Behaviors Scale.
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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.
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Quality of life
Tidsramme: 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.
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SF-36.
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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.
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Health-Care Climate
Tidsramme: After the end of the 12-week intervention (t=3 mo).
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Health-Care Climate Questionnaire.
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After the end of the 12-week intervention (t=3 mo).
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Simone Lemieux, Ph.D., Dt.P, Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2010
Primær færdiggørelse (Faktiske)
1. november 2012
Studieafslutning (Faktiske)
1. november 2012
Datoer for studieregistrering
Først indsendt
9. maj 2013
Først indsendt, der opfyldte QC-kriterier
9. maj 2013
Først opslået (Skøn)
14. maj 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. september 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. september 2013
Sidst verificeret
1. september 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2009-213 A1
- MOP 84568 (Andet bevillings-/finansieringsnummer: Canadian Institutes of Health Research (MOP 84568))
- 2007-180 (Andet bevillings-/finansieringsnummer: Heart and Stroke Foundation of Quebec (2007-180))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .