Gender Differences in Response to the Mediterranean Diet-Part 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Diet adherence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Diet adherence
时间窗: 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.
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.
次要结局
- 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).)
- Motivational variables in a nutrition context(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.)
- Quality of life(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.)
- Health-Care Climate(After the end of the 12-week intervention (t=3 mo).)