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临床试验/NCT04273048
NCT04273048终止不适用

A Dietary and Exercise Intervention in Overweight and Obese Women Undergoing Fertility Treatment

Arkansas Children's Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年7月21日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

No Intervention

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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