Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
5. září 2013 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
123
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Quebec
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Québec, Quebec, Kanada, G1V 0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
25 let až 50 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Diet adherence
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Dietary intakes
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Simone Lemieux, Ph.D., Dt.P, Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. března 2010
Primární dokončení (Aktuální)
1. listopadu 2012
Dokončení studie (Aktuální)
1. listopadu 2012
Termíny zápisu do studia
První předloženo
9. května 2013
První předloženo, které splnilo kritéria kontroly kvality
9. května 2013
První zveřejněno (Odhad)
14. května 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
6. září 2013
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. září 2013
Naposledy ověřeno
1. září 2013
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2009-213 A1
- MOP 84568 (Jiné číslo grantu/financování: Canadian Institutes of Health Research (MOP 84568))
- 2007-180 (Jiné číslo grantu/financování: Heart and Stroke Foundation of Quebec (2007-180))
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .