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

NCT ID: NCT06975527

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2025-09-10

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Breastfeeding guidelines group

The participants will receive breastfeeding guidelines for 6 weeks

Group Type: ACTIVE_COMPARATOR

Breastfeeding guidelines

Intervention Type: 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 and breastfeeding guidelines

The participants will receive aerobic exercises for 40 minutes, 3 times per week in addition to breastfeeding guidelines for 6 weeks.

Group Type: EXPERIMENTAL

Breastfeeding guidelines

Intervention Type: 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

Intervention Type: 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.

Interventions

Breastfeeding guidelines

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.

Intervention Type: OTHER

Aerobic exercise

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mai Elshafei

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Afaf Botla, Professor

Role: STUDY_DIRECTOR

Cairo University

Dalia Kamel, Professor

Role: STUDY_CHAIR

Cairo University

Locations

Mai mohamed mohamed Elshafei

Beheira, , Egypt

Countries

Egypt

Central Contacts

Mai ELShafei

Role: CONTACT

Mai.mo7amed306@gmail.com

+201015431012

Ahmed ossman, professor

Role: CONTACT

ahmed.osman3@med.tanta.edu.eg

+201201513988

Other Identifiers

P.T.REC/012/003736

Identifier Type: -

Identifier Source: org_study_id