Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women

Not Applicable

Not yet recruiting

• Conditions: Breastfeeding

• Registration Number: NCT06975527
• Lead Sponsor: Cairo University

Brief Summary

This study will investigate the milk production and body weight response of both mother and the newborn to aerobic exercise in obese lactating women.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-05-20
• Primary Completion: 2025-08-30
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Anemia
• Having twins or causes that hindering normal breast feeding as (mastitis, retracted, cracked, inflamed or inverted nipple)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of the degree of improvement in the flow of milk	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	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	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	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.

Trial Locations

Locations (1)

Mai mohamed mohamed Elshafei; 🇪🇬 Beheira, Egypt