Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Assessment of the degree of improvement in the flow of milk
研究概览
简要总结
This study will investigate the milk production and body weight response of both mother and the newborn to aerobic exercise in obese lactating women.
详细描述
Breastfeeding is a normal method of providing nutrition to young infant by breast milk. Breastfeeding is equally important and beneficial for not only infant but also for the mother.
Women with high BMI have delays in establishing lactation after giving birth. In addition, overweight and obesity increase the risk of early cessation of breastfeeding.
Aerobic exercises have positive effects on breastfeeding frequency and body weight of neonate and can increase blood flow to the chest which is effective in lactation performance.
So, this study will help to evaluate the efficacy of aerobic exercise in addition to guidelines for breastfeeding, nutrition and fluid intake on milk production, baby and mother weight.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Multiparous obese mothers having number of parity ranges from two to four times.
- •Lactating mothers within 2nd month after delivery.
- •All of them diagnosed by gynecologist as having insufficient lactation
- •Age will range from 25-35 years old.
- •Body mass index: 30-40 Kg/m².
排除标准
- •Lactating women suffering from postpartum hemorrhage
- •Poor mammary development
- •Cardio respiratory disease
- •Diabetes mellitus
- •Breast cancer
- •Getting pregnant again during breast feeding period
- •Mental disorders
- •Previous surgeries in the chest, breast or the surrounding area
- •Having twins or causes that hindering normal breast feeding as (mastitis, retracted, cracked, inflamed or inverted nipple)
研究组 & 干预措施
Breastfeeding guidelines group
The participants will receive breastfeeding guidelines for 6 weeks
干预措施: Breastfeeding guidelines (Other)
Aerobic exercise and breastfeeding guidelines
The participants will receive aerobic exercises for 40 minutes, 3 times per week in addition to breastfeeding guidelines for 6 weeks.
干预措施: Breastfeeding guidelines (Other)
Aerobic exercise and breastfeeding guidelines
The participants will receive aerobic exercises for 40 minutes, 3 times per week in addition to breastfeeding guidelines for 6 weeks.
干预措施: Aerobic exercise (Other)
结局指标
主要结局
Assessment of the degree of improvement in the flow of milk
时间窗: 6 weeks
Each lactating mother in both groups will have a visual analogue scale (VAS) form containing a straight line its ends are defined as the extreme limits of milk flow. The mother will select the suitable description of her milk flow before and after the end of the treatment procedures. The scale ranged from 0-4. 0 means no milk flow. 4 means extreme milk flow.
Serum prolactin level
时间窗: 6 weeks
ELISA Kit will be used for quantitative determination of the human prolactin concentration in serum. it will be measured for all lactating women before and after the treatment. Normal prolactin level is ranged from 100:110 ng/ml.
Weight of the baby
时间窗: 6 weeks
The baby will be weighed in kilograms at the beginning and after the end of treatment period by placing the baby over the baby weight scale wearing only the underwear and the baby diapers are removed.
Weight of the mother
时间窗: 6 weeks
The lactating mother will be weighed in kilograms by the weight scale while wearing a thin layer of clothes and with bare feet to assess and compare her weight before and after the end of the treatment period.
次要结局
未报告次要终点
研究者
Mai Elshafei
Principal investigator
Cairo University