Breastfeeding WomenMOMSNCT01971216
Mother-infant Signalling During Breastfeeding
A study testing Relaxation in people with Breastfeeding Women, run by University College, London at 1 site in Malaysia.
Trial summary
Primary hypotheses 1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding Women
- What is being tested?
- Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2013to Jan 2017
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous mother with singleton pregnancy Infant is singleton and born at term (37-42 week of gestation) Infant birth weight of >2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).
- No current or recent involvement in other research studies that could potentially affect any of outcome measures.
- Mother speaks and understands either English only or English and Malay (some questionnaires are in English)
Who cannot join
- Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.
- Mother smokes Mothers who do not exclusively breastfeed their infant
- -
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Medicine and Health Science, Universiti Putra Malaysia (UPM).
Kuala Lumpur
About this study
Official title: Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.
Primary hypotheses
- The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)
Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.
- Conditions
- Breastfeeding Women
- Being tested
- Relaxation
- Keywords
- Breastfeeding, relaxation, anxiety, infant growth
- Medical subject headings
- Breast Feeding, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RelaxationBehavioural
Also called Relaxation tape - audio tape with visual imagery and relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Breastfeeding mothers who are not randomised to relaxation intervention |
| Relaxation | Experimental | Breastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal stress and anxiety
Maternal stress and anxiety assessed using the Cohen's Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) respectively (change in score from baseline to end-point at 12 weeks)
Measured: Baselibne to 12 weeks
Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
Measured: 12 weeks
Breast milk cortisol concentrations at 12 weeks
Measured: 12 weeks
Infant behaviour measured using a 3-day diary at 12 weeks
Measured: 12 weeks
Infant weight and body composition measured using stable isotopes at 12 weeks
Measured: 12 weeks
Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks.
Measured: 2,6,12 weeks
Secondary outcomes (2)
Non-nutrient factors in breast milk - leptin and ghrelin
Measured: 2,6,12 weeks
Macronutrient composition of breast milk (fat and protein)
Measured: 2,6,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding WomenStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Fewtrell, MD, Principal investigator, UCL Institute of Child Health, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971216
- Sponsor's protocol ID
- 13NT05
- Acronym
- MOMS
- Status last verified
- Jul 2018
- First submitted
- 23 Oct 2013
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
PubMed 31161202Shukri NHM, Wells J, Mukhtar F, Lee MHS, Fewtrell M. Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth. Int Breastfeed J. 2017 Jul 14;12:33. doi: 10.1186/s13006-017-0124-y. eCollection 2017.
PubMed 28725257
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mother-infant Signalling During Breastfeeding: A Randomised Trial Investigating the Effects of a Relaxation Intervention in Breastfeeding Mothers on Breast Milk Production, Breast Milk Cortisol and Infant Behaviour and Growth.
- ClinicalTrials.gov ID
- NCT01971216
- Acronym / sponsor ID
- MOMS / 13NT05
- Conditions
- Breastfeeding Women
- Keywords
- Breastfeeding, relaxation, anxiety, infant growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Oct 2013 (estimated)
- 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.
Primary hypotheses
- The use of a relaxation tape by breastfeeding mothers that will be given starting at week 2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more optimal growth, specifically higher lean mass and lower fat mass (body composition)
Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and hence infant growth and body composition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Breastfeeding mothers who are not randomised to relaxation intervention |
| Relaxation | Experimental | Behavioral: RelaxationBreastfeeding mothers randomised to use relaxation tape at 2 weeks post-partum |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Primiparous mother with singleton pregnancy Infant is singleton and born at term (37-42 week of gestation) Infant birth weight of >2500 g (5,5 pounds or 5 pounds and 8,2 ounces) Mother and infant are generally healthy (free of serious illness that can affect breastfeeding or nursing infant, or energy balance of the infant).
- No current or recent involvement in other research studies that could potentially affect any of outcome measures.
- Mother speaks and understands either English only or English and Malay (some questionnaires are in English)
Key exclusion criteria (3 listed)
- Mother or baby has a major illness that affects nursing or breastfeeding, or affects energy balance of the infant.
- Mother smokes Mothers who do not exclusively breastfeed their infant
- -
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 |
|---|---|---|
| RelaxationAlso: Relaxation tape - audio tape with visual imagery and relaxation exercises | Behavioural | Relaxation |
Primary outcome
Maternal stress and anxiety
Time frame: Baselibne to 12 weeks
Maternal stress and anxiety assessed using the Cohen's Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) respectively (change in score from baseline to end-point at 12 weeks)
Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
Time frame: 12 weeks
Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques
Breast milk cortisol concentrations at 12 weeks
Time frame: 12 weeks
Infant behaviour measured using a 3-day diary at 12 weeks
Time frame: 12 weeks
Infant weight and body composition measured using stable isotopes at 12 weeks
Time frame: 12 weeks
Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks.
Time frame: 2,6,12 weeks
2 secondary outcomes
Non-nutrient factors in breast milk - leptin and ghrelin
Time frame: 2,6,12 weeks
Macronutrient composition of breast milk (fat and protein)
Time frame: 2,6,12 weeks
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 12 Jul 2018.
- Derived from this study: PubMed 31161202Mohd Shukri NH, Wells J, Eaton S, Mukhtar F, Petelin A, Jenko-Praznikar Z, Fewtrell M. Randomized controlled trial investigating the effects of a breastfeeding relaxation intervention on maternal psychological state, breast milk outcomes, and infant behavior and growth. Am J Clin Nutr. 2019 Jul 1;110(1):121-130. doi: 10.1093/ajcn/nqz033.
- Derived from this study: PubMed 28725257Shukri NHM, Wells J, Mukhtar F, Lee MHS, Fewtrell M. Study protocol: An investigation of mother-infant signalling during breastfeeding using a randomised trial to test the effectiveness of breastfeeding relaxation therapy on maternal psychological state, breast milk production and infant behaviour and growth. Int Breastfeed J. 2017 Jul 14;12:33. doi: 10.1186/s13006-017-0124-y. eCollection 2017.
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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.
Mary Fewtrell, MD principal investigator
UCL Institute of Child Health, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation in people with Breastfeeding Women, run by University College, London at 1 site in Malaysia.
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 3 inclusion and 3 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 12 Jul 2018. 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 Malaysia. 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?
Maternal stress and anxiety (time frame: Baselibne to 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971216, which also lists 2 linked publications.
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 12 Jul 2018.