BreastfeedingNCT06975527
Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women
A study testing Breastfeeding guidelines and Aerobic exercise in people with Breastfeeding, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Breastfeeding guidelines and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Lactating women suffering from postpartum hemorrhage
- Poor mammary development
- Cardio respiratory disease
- Diabetes mellitus
- Breast cancer
- Getting pregnant again during breast feeding period
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the milk production and body weight response of both mother and the newborn to aerobic exercise in obese lactating women.
Read the 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
- Being tested
- Breastfeeding guidelines, Aerobic exercise
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breastfeeding guidelinesOther
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 exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding guidelines group | Active comparator | The participants will receive breastfeeding guidelines for 6 weeks Receives: 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. Receives: Other: Breastfeeding guidelines; Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start20 May 2025
- Primary completion30 Aug 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elshafei, Cairo University
- Investigators
- Afaf Botla, Professor, Study director, Cairo UniversityDalia Kamel, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975527
- Sponsor's protocol ID
- P.T.REC/012/003736
- Status last verified
- Jul 2026
- First submitted
- 6 May 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk Production and Body Weight Response to Suggested Protocol in Obese Lactating Women
- ClinicalTrials.gov ID
- NCT06975527
- Acronym / sponsor ID
- P.T.REC/012/003736
- Conditions
- Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding guidelines group | Active comparator | Other: Breastfeeding guidelinesThe participants will receive breastfeeding guidelines for 6 weeks |
| Aerobic exercise and breastfeeding guidelines | Experimental | Other: Breastfeeding guidelines, Other: Aerobic exerciseThe participants will receive aerobic exercises for 40 minutes, 3 times per week in addition to breastfeeding guidelines for 6 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Lactating women suffering from postpartum hemorrhage
- Poor mammary development
- Cardio respiratory disease
- Diabetes mellitus
- Breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breastfeeding guidelinesAll 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. | Other | Aerobic exercise and breastfeeding guidelines, Breastfeeding guidelines group |
| Aerobic exerciseThe 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. | Other | Aerobic exercise and breastfeeding guidelines |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afaf Botla, Professor study director
Cairo University
Dalia Kamel, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breastfeeding guidelines and Aerobic exercise in people with Breastfeeding, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the degree of improvement in the flow of milk (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.