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

NCT06975527 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/003736
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (4)

• Assessment of the degree of improvement in the flow of milk

  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.

  6 weeks

• Serum prolactin level

  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.

  6 weeks

• Weight of the baby

  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.

  6 weeks

• Weight of the mother

  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.

  6 weeks

Study Arms (2)

Breastfeeding guidelines group

ACTIVE COMPARATOR

The participants will receive breastfeeding guidelines for 6 weeks

Other: Breastfeeding guidelines

Aerobic exercise and breastfeeding guidelines

EXPERIMENTAL

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

Other: Breastfeeding guidelines; Other: Aerobic exercise

Interventions

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 and breastfeeding guidelines; Breastfeeding guidelines group

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.

Aerobic exercise and breastfeeding guidelines

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mai mohamed mohamed Elshafei

Beheira, Egypt

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Exercise

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Afaf Botla, Professor

  Cairo University

  STUDY DIRECTOR

• Dalia Kamel, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mai ELShafei

CONTACT

+201015431012; Mai.mo7amed306@gmail.com

Ahmed ossman, professor

CONTACT

+201201513988; ahmed.osman3@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 16, 2025
• Study Start: May 20, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 10, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

EG (1)