Effects of the Mediterranean Diet on Cardiovascular Risk Profile in Men and Women (ALIMED)-Part 2
2013年9月5日 更新者：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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
123
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec
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Québec、Quebec、加拿大、G1V 0A6
- Institute of Nutraceuticals and Functional Foods (INAF), Laval University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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实验性的：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Diet adherence
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dietary intakes
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Simone Lemieux, Ph.D., Dt.P、Department of food sciences and nutrition / Institute of Nutraceutical and Functional Foods (INAF), Laval University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年3月1日
初级完成 (实际的)
2012年11月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2013年5月9日
首先提交符合 QC 标准的
2013年5月9日
首次发布 (估计)
2013年5月14日
研究记录更新
最后更新发布 (估计)
2013年9月6日
上次提交的符合 QC 标准的更新
2013年9月5日
最后验证
2013年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Experimental: Men and Mediterranean diet的临床试验
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Ottawa Hospital Research InstituteBioMérieux; Centre Hospitalier Régional et Universitaire de Brest完全的