A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Follicular fluid content
研究概览
简要总结
This research study is about the effects of diet and exercise in women undergoing fertility treatment.
详细描述
This study will randomize women who are undergoing fertility treatment and put them either in an intervention group or standard care. This study should help us learn if diet and exercise changes oocytes gene expression and follicular fluid content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI 25 - 45 kg/m2
- •≥ 21 years of age
排除标准
- •Pre-existing conditions (e.g. sexual transmitted diseases) that will affect the outcomes of the study as determined by the principal investigator
- •Current use of recreational drugs, tobacco, or alcohol
- •Food allergies, intolerances or preferences which would interfere with compliance to the meal plan
- •Contraindications to exercise
- •Already meeting the physical activity guidelines (150 min moderate activity/week or 75 minutes of vigorous activity/week with resistance exercise on 2 or more days/week).
研究组 & 干预措施
Diet and Exercise
Group 1 = Diet Intervention group: They will be asked to follow a personalized diet during study period and record what they eat. The meal plan for this study is Mediterranean style and nutritionally complete for 8 to 12 weeks or until oocyte retrieval procedure. Exercise Intervention: Exercise 3 times/week at a gym of their choice or at home for 8 to 12 weeks or until oocyte retrieval procedure. Exercises will be light intensity and short duration at first and will gradually increase to moderate intensity and longer duration during the first 3 weeks. They will also be encouraged to walk an average 10,000 steps per day and wear a pedometer to monitor progress.
干预措施: Diet Intervention - Group 1 (Other)
Diet and Exercise
Group 1 = Diet Intervention group: They will be asked to follow a personalized diet during study period and record what they eat. The meal plan for this study is Mediterranean style and nutritionally complete for 8 to 12 weeks or until oocyte retrieval procedure. Exercise Intervention: Exercise 3 times/week at a gym of their choice or at home for 8 to 12 weeks or until oocyte retrieval procedure. Exercises will be light intensity and short duration at first and will gradually increase to moderate intensity and longer duration during the first 3 weeks. They will also be encouraged to walk an average 10,000 steps per day and wear a pedometer to monitor progress.
干预措施: Exercise Intervention - Group 1 (Other)
Standard Care
Group 2 = Standard: They will receive standard care from the Little Rock Fertility Center.
结局指标
主要结局
Follicular fluid content
时间窗: 8-12 weeks
Follicular fluid content
Oocyte gene expression profile
时间窗: 8-12 weeks
Oocyte gene expression
次要结局
未报告次要终点
