Skip to main content
OpenTrials
Completed

NCT Number: NCT06975527

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mai mohamed mohamed Elshafei

Beheira, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Breastfeeding guidelines

Other

All participants will be instructed by the following guidelines:

  • Hold the breast so the nipple brushes the center of the infant's lips and wait for the infant to open the mouth.
  • Infant's mouth should be opened wide, as with a yawn and should cover the entire areola, or a large amount of the areola.
  • Both breasts are used in each feeding, usually 10 to 15 minutes on the first side, followed by burping before beginning the second side.
  • Break suction by placing finger in the corner of infant's mouth and quickly remove breast.
  • Apply breast massage before breastfeeding.
  • The neonate is nursed shortly after birth and approximately every 2 to 3 hours thereafter for a total of 8 to 12 feedings a day.
  • Lactating women needs about 8 to 10 glasses of fluids per day while breastfeeding.
  • Caffeine consumption should be limited to 2 cups of coffee, tea or cola per day.
  • Lactating mother should consume a healthy diet which is varied, balanced, and natural.

Aerobic Exercise

Other

The participants will be engaged in a supervised moderate aerobic exercise in the form of walking on a treadmill for 40 minutes/ day, 3 days/ week, for 6 weeks beginning 6:8 weeks postpartum. Each exercise session will be divided into 3 phases. The warm-up phase begins with walking at low speed (within resting heart rate) on a treadmill for 5 minutes. The active phase continues for 30 minutes at a moderate intensity of 60 to 70% of maximal heart rate (HRmax). Gradual increase and adjustment of speed will be applied for each woman according to her prescribed intensity based on HRmax. HRmax is calculated by subtracting the age from 220. The program will be terminated with 5 minutes cool-down phase, during which the treadmill speed will be gradually decreased until the heart rate resumes its resting level.

Primary outcomes

  1. Assessment of the degree of improvement in the flow of milk

    Time frame: 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.

  2. Serum prolactin level

    Time frame: 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.

  3. Weight of the baby

    Time frame: 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.

  4. Weight of the mother

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.