Breastfeeding DurationNCT06751186
Effect of Teté Dance on Breastfeeding Duration in Irritable Infants
A study testing Teté Dance Guided Support in people with Breastfeeding Duration and Infant Feeding Practices, run by Crianzamor at 1 site in Peru.
Trial summary
This study aims to evaluate the impact of a culturally adapted intervention, the Teté Dance, on the breastfeeding duration of irritable infants. Participants will be mothers of infants experiencing irritability during feeding. Read more about this study
- Who is it for?
- Ages 4 to 20 weeks
- Conditions the study is for
- Breastfeeding Duration, Infant Feeding Practices
- What is being tested?
- Teté Dance Guided Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePeru
- Study dates
- 29 Nov 2022to 28 Jan 2023
- 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 4 to 20 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 4 to 20 weeks.
- Infants identified as "demanding," meaning those with frequent irritability, restlessness, or excessive crying during breastfeeding attempts, without an underlying medical condition.
- Mothers who have completed secondary education.
Who cannot join
- Infants with significant clinical conditions.
- Infants with inadequate growth.
- Infants exclusively fed with formula.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 'Teté Dance' on the Duration of the Lactation Session in Irritable Infants in Peru: a Randomized Controlled Trial
This study aims to evaluate the impact of a culturally adapted intervention, the Teté Dance, on the breastfeeding duration of irritable infants. Participants will be mothers of infants experiencing irritability during feeding. The study involves comparing two groups: an intervention group practicing the Teté Dance and a control group receiving standard breastfeeding support.
Researchers will assess breastfeeding session duration over a seven-day period to determine whether the Teté Dance helps extend feeding times. Participants in the intervention group will receive guided sessions from trained facilitators in a community setting, while the control group will continue with usual care.
By focusing on culturally sensitive practices, this research aims to provide a low-cost, practical solution for improving breastfeeding outcomes in resource-limited settings. Participants will be evaluated for eligibility based on specific criteria, including willingness to participate and the infant's health status. Results from this trial may contribute to global breastfeeding support strategies.
Read the detailed description
This randomized controlled trial will investigate the effect of the Teté Dance, a culturally adapted maternal intervention, on breastfeeding session durations in irritable infants. Rooted in traditional Peruvian Amazonian practices, the Teté Dance integrates rhythmic maternal movements and cheerful music to create a calming environment conducive to prolonged breastfeeding.
The study will employ a parallel design with two groups: an intervention group practicing the Teté Dance and a control group receiving standard breastfeeding support. The intervention will be delivered through a combination of in-person and virtual training sessions led by trained facilitators, ensuring consistency in technique application. Mothers in the intervention group will be provided with resources, including tutorial videos and culturally tailored music playlists, to support implementation at home.
Data collection will focus on breastfeeding session durations over a seven-day period. Diaries maintained by mothers will be validated daily by blinded staff to ensure the accuracy and reliability of the recorded information. The trial will be structured to evaluate not only the immediate effects of the intervention but also its feasibility and acceptability as a culturally sensitive support strategy.
The Teté Dance aims to represent an innovative approach that leverages cultural traditions to address breastfeeding challenges in resource-limited settings. By combining traditional practices with modern support frameworks, this intervention seeks to provide a scalable and low-cost solution to improve breastfeeding outcomes globally.
Findings from this study are expected to contribute to the growing evidence supporting culturally adapted maternal interventions and may inform the development of public health policies aimed at reducing early breastfeeding cessation and its associated health risks.
- Conditions
- Breastfeeding Duration, Infant Feeding Practices
- Being tested
- Teté Dance Guided Support
- Keywords
- Breastfeeding Duration, Irritable Infants, Maternal Support, Teté Dance Intervention, Breastfeeding Practices, Cultural Lactation Support, Infant Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teté Dance Guided SupportBehavioural
A culturally tailored behavioral intervention combining physical activity and community engagement to support breastfeeding practices.
| Study group | Role | What they receive |
|---|---|---|
| Teté Dance Intervention | Experimental | Participants in this group will receive guided sessions of the Teté Dance facilitated by trained individuals over a seven-day period to improve breastfeeding session duration. Receives: Behavioral: Teté Dance Guided Support |
| Standard Breastfeeding Support | No intervention | Participants in this group will receive standard breastfeeding support as provided by usual care practices, without any additional interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Session Duration
Measurement of the total duration of breastfeeding sessions recorded by participants in minutes. This measure aims to evaluate the impact of the Teté Dance intervention on breastfeeding behavior.
Measured: 7 days from intervention start date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start29 Nov 2022
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding DurationStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crianzamor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier H Ravichagua Ashiyama, MD, Principal investigator, Crianzamor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751186
- Sponsor's protocol ID
- 202400018
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share de-identified individual participant data on breastfeeding session durations measured at baseline and at the end of the intervention period. These data will be shared to facilitate secondary analyses and further research on culturally sensitive breastfeeding interventions. Data will be available upon reasonable request and approval by the study investigators.
Publications
Jiang H, Li M, Wen LM, Hu Q, Yang D, He G, Baur LA, Dibley MJ, Qian X. Effect of short message service on infant feeding practice: findings from a community-based study in Shanghai, China. JAMA Pediatr. 2014 May;168(5):471-8. doi: 10.1001/jamapediatrics.2014.58.
PubMed 24639004Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. doi: 10.1002/14651858.CD001141.pub3.
PubMed 17253455Rollins NC, Bhandari N, Hajeebhoy N, Horton S, Lutter CK, Martines JC, Piwoz EG, Richter LM, Victora CG; Lancet Breastfeeding Series Group. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016 Jan 30;387(10017):491-504. doi: 10.1016/S0140-6736(15)01044-2.
PubMed 26869576Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
PubMed 23746772Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.
PubMed 26192560
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 'Teté Dance' on the Duration of the Lactation Session in Irritable Infants in Peru: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06751186
- Acronym / sponsor ID
- 202400018
- Conditions
- Breastfeeding Duration, Infant Feeding Practices
- Keywords
- Breastfeeding Duration, Irritable Infants, Maternal Support, Teté Dance Intervention, Breastfeeding Practices, Cultural Lactation Support, Infant Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- CrianzamorUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 27 Dec 2024 (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 aims to evaluate the impact of a culturally adapted intervention, the Teté Dance, on the breastfeeding duration of irritable infants. Participants will be mothers of infants experiencing irritability during feeding. The study involves comparing two groups: an intervention group practicing the Teté Dance and a control group receiving standard breastfeeding support.
Researchers will assess breastfeeding session duration over a seven-day period to determine whether the Teté Dance helps extend feeding times. Participants in the intervention group will receive guided sessions from trained facilitators in a community setting, while the control group will continue with usual care.
By focusing on culturally sensitive practices, this research aims to provide a low-cost, practical solution for improving breastfeeding outcomes in resource-limited settings. Participants will be evaluated for eligibility based on specific criteria, including willingness to participate and the infant's health status. Results from this trial may contribute to global breastfeeding support strategies.
Detailed description
This randomized controlled trial will investigate the effect of the Teté Dance, a culturally adapted maternal intervention, on breastfeeding session durations in irritable infants. Rooted in traditional Peruvian Amazonian practices, the Teté Dance integrates rhythmic maternal movements and cheerful music to create a calming environment conducive to prolonged breastfeeding.
The study will employ a parallel design with two groups: an intervention group practicing the Teté Dance and a control group receiving standard breastfeeding support. The intervention will be delivered through a combination of in-person and virtual training sessions led by trained facilitators, ensuring consistency in technique application. Mothers in the intervention group will be provided with resources, including tutorial videos and culturally tailored music playlists, to support implementation at home.
Data collection will focus on breastfeeding session durations over a seven-day period. Diaries maintained by mothers will be validated daily by blinded staff to ensure the accuracy and reliability of the recorded information. The trial will be structured to evaluate not only the immediate effects of the intervention but also its feasibility and acceptability as a culturally sensitive support strategy.
The Teté Dance aims to represent an innovative approach that leverages cultural traditions to address breastfeeding challenges in resource-limited settings. By combining traditional practices with modern support frameworks, this intervention seeks to provide a scalable and low-cost solution to improve breastfeeding outcomes globally.
Findings from this study are expected to contribute to the growing evidence supporting culturally adapted maternal interventions and may inform the development of public health policies aimed at reducing early breastfeeding cessation and its associated health risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teté Dance Intervention | Experimental | Behavioral: Teté Dance Guided SupportParticipants in this group will receive guided sessions of the Teté Dance facilitated by trained individuals over a seven-day period to improve breastfeeding session duration. |
| Standard Breastfeeding Support | No intervention | –Participants in this group will receive standard breastfeeding support as provided by usual care practices, without any additional interventions. |
Who may qualify
- Ages
- 4 to 20 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants aged 4 to 20 weeks.
- Infants identified as "demanding," meaning those with frequent irritability, restlessness, or excessive crying during breastfeeding attempts, without an underlying medical condition.
- Mothers who have completed secondary education.
Key exclusion criteria (3 listed)
- Infants with significant clinical conditions.
- Infants with inadequate growth.
- Infants exclusively fed with formula.
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 |
|---|---|---|
| Teté Dance Guided SupportA culturally tailored behavioral intervention combining physical activity and community engagement to support breastfeeding practices. | Behavioural | Teté Dance Intervention |
Primary outcome
Breastfeeding Session Duration
Time frame: 7 days from intervention start date.
Measurement of the total duration of breastfeeding sessions recorded by participants in minutes. This measure aims to evaluate the impact of the Teté Dance intervention on breastfeeding behavior.
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 30 Dec 2024.
- Background: PubMed 24639004Jiang H, Li M, Wen LM, Hu Q, Yang D, He G, Baur LA, Dibley MJ, Qian X. Effect of short message service on infant feeding practice: findings from a community-based study in Shanghai, China. JAMA Pediatr. 2014 May;168(5):471-8. doi: 10.1001/jamapediatrics.2014.58.
- Background: PubMed 17253455Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. doi: 10.1002/14651858.CD001141.pub3.
- Background: PubMed 26869576Rollins NC, Bhandari N, Hajeebhoy N, Horton S, Lutter CK, Martines JC, Piwoz EG, Richter LM, Victora CG; Lancet Breastfeeding Series Group. Why invest, and what it will take to improve breastfeeding practices? Lancet. 2016 Jan 30;387(10017):491-504. doi: 10.1016/S0140-6736(15)01044-2.
- Background: PubMed 23746772Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
- Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Background: PubMed 26192560Horta BL, Loret de Mola C, Victora CG. Long-term consequences of breastfeeding on cholesterol, obesity, systolic blood pressure and type 2 diabetes: a systematic review and meta-analysis. Acta Paediatr. 2015 Dec;104(467):30-7. doi: 10.1111/apa.13133.
- This link provides access to WHO's e-Library of Evidence for Nutrition Actions (eLENA), with guidelines on exclusive breastfeeding for optimal growth, development, and health in infants, along with public health strategies.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share de-identified individual participant data on breastfeeding session durations measured at baseline and at the end of the intervention period. These data will be shared to facilitate secondary analyses and further research on culturally sensitive breastfeeding interventions. Data will be available upon reasonable request and approval by the study investigators.
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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.
Javier H Ravichagua Ashiyama, MD principal investigator
Crianzamor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teté Dance Guided Support in people with Breastfeeding Duration and Infant Feeding Practices, run by Crianzamor at 1 site in Peru.
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 30 Dec 2024. 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 Peru. 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?
Breastfeeding Session Duration (time frame: 7 days from intervention start date.). 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 NCT06751186, which also lists 6 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 30 Dec 2024.