COaching Lifestyle Intervention for FErtility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,560
- 主要终点
- Behavior change
研究概览
简要总结
In Finland, every third woman is overweight (BMI>25) and 11,5% obese (BMI>30). Cohort and national studies reveal that 46% of fertile-aged men have BMI≥25 and 20% BMI≥30. Overweight has negative impact on both female and male fertility and weakens markedly the results of infertility treatments. In this study, 780 infertile couples will be randomized to control group (conventional infertility treatment) and lifestyle intervention arm undergoing 4 sessions of video-mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Economic evaluation of the intervention will also be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infertility
- •BMI 27-34.9 kg/m2
排除标准
- •no mobile device available
- •evident sperm defect or ovarian tube block
- •hinder for fluent treatment schedule due to the subjec´s obstacle (inadequate language skills, major time table problems)
结局指标
主要结局
Behavior change
时间窗: 6 months
score from 1 to 4: (smoking + daily vegetable, fruit and berry use \>500g + BMI 19-27 + 150 min of moderate exercise/week) No=0, Yes=1 measured at the beginning, at 3 and 6 months
Live birth rate
时间窗: 3 years
Number of live children born
Weight change
时间窗: 6 months
weight in kg measured without shoes and with light clothing at the beginning, at 3 and 6 months
次要结局
- Infertility treatments, number(3 years)
- Infertility treatments, mode(3 years)
- Miscarriage rate(3 years)
- Height(0 months)
- Weight(6 months)
- Body mass index(6 months)
- Waist circumference(6 months)
- Protein(6 months)
- Body composition(6 months)
- Self-reported physical activity(6 months)
- Physical activity(6 months)
- Maximal oxygen uptake(6 months)
- Dietary content(6 months)
- Alcohol(6 months)
- Saturated fatty acids(6 months)
- Monounsaturated fatty acids(6 months)
- Dietary patterns(6 months)
- Folate(6 months)
- Vitamin-D(6 months)
- Zinc(6 months)
- Carbohydrates(6 months)
- n-3 fatty acids(6 months)
- n-6 fatty acids(6 months)
- Sleep, measured(6 months)
- Polyunsaturated fatty acids(6 months)
- Sleep(6 months)
- Intention and action planning for physical activity; Intention to increase physical activity(6 months)
- Sperm epigenetic profile(6 months)
- Stress recovery(6 months)
- Anxiety and depression(6 months)
- Fertility quality of life(6 months)
- Depression(6 months)
- Self-efficacy for physical activity(6 months)
- Pregnancy complications(3 years)
- Delivery complications(3 years)
- Neonatal outcome(3 years)
- Body composition of the newborn(At birth)
- Growth of the child(Up to 16 years of age)
- Transcriptome(6 months)
- Sperm oxidative stress(6 months)
- Self-determined motivation for physical activity(6 months)
- A cost-utility of the intervention(3 years)
- QALY baseline(0 months)
- QALY end point(6 months)
- Cost-effectiveness(3 years)
- Perception of stress(6 months)
- Personality dimensions(6 months)
- Static postural balance(3 months postpartum)
研究者
Maritta Poyhonen-Alho
Principal investigator
Helsinki University Central Hospital