NCT06751186

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 20, 2024

Last Update Submit

December 26, 2024

Conditions

Keywords

Breastfeeding DurationIrritable InfantsMaternal SupportTeté Dance InterventionBreastfeeding PracticesCultural Lactation SupportInfant Nutrition

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

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.

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.

Interventions

A culturally tailored behavioral intervention combining physical activity and community engagement to support breastfeeding practices.

Teté Dance Intervention

Eligibility Criteria

Age4 Weeks - 20 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Crianzamor

Piura, Piura, Peru

Location

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: 24639004BACKGROUND
  • Britton 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: 17253455BACKGROUND
  • Rollins 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: 26869576BACKGROUND
  • Black 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: 23746772BACKGROUND
  • Victora 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: 26869575BACKGROUND
  • Horta 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

  • Javier H Ravichagua Ashiyama, MD

    Crianzamor

    PRINCIPAL INVESTIGATOR

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

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.

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.

Locations