Effect of Teté Dance on Breastfeeding Duration in Irritable Infants
Effect of 'Teté Dance' on the Duration of the Lactation Session in Irritable Infants in Peru: a Randomized Controlled Trial
1 other identifier
interventional
150
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2023
CompletedFirst Submitted
Initial submission to the registry
December 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedDecember 30, 2024
December 1, 2024
2 months
December 20, 2024
December 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 days from intervention start date.
Study Arms (2)
Teté Dance Intervention
EXPERIMENTALParticipants 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 INTERVENTIONParticipants in this group will receive standard breastfeeding support as provided by usual care practices, without any additional interventions.
Interventions
A culturally tailored behavioral intervention combining physical activity and community engagement to support breastfeeding practices.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Infants with significant clinical conditions.
- Infants with inadequate growth.
- Infants exclusively fed with formula.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Crianzamorlead
Study Sites (1)
Crianzamor
Piura, Piura, Peru
Related Publications (6)
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.
PMID: 24639004BACKGROUNDBritton 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.
PMID: 17253455BACKGROUNDRollins 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.
PMID: 26869576BACKGROUNDBlack 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.
PMID: 23746772BACKGROUNDVictora 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.
PMID: 26869575BACKGROUNDHorta 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.
PMID: 26192560BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Javier H Ravichagua Ashiyama, MD
Crianzamor
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
- SPONSOR
Study Record Dates
First Submitted
December 20, 2024
First Posted
December 27, 2024
Study Start
November 29, 2022
Primary Completion
January 28, 2023
Study Completion
January 28, 2023
Last Updated
December 30, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- The individual participant data (IPD) and supporting information will be available starting from the date of publication of the primary research article and will remain accessible for one year. Researchers can request access during this period by contacting the study team.
- Access Criteria
- Access to the individual participant data (IPD) and supporting information will be granted to researchers affiliated with recognized institutions, organizations, or academic bodies. They will have access to the breastfeeding duration data collected at baseline and at the end of the intervention. To request access, researchers must submit a formal application detailing the purpose of use, supported by institutional approval. Data will be shared through a secure data-sharing platform upon agreement to a data-sharing contract that ensures confidentiality and proper data usage.
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.