Effect of Teté Dance on Breastfeeding Duration in Irritable Infants

December 26, 2024 updated by: Crianzamor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Piura, Peru
        • Crianzamor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Infants with significant clinical conditions.
  • Infants with inadequate growth.
  • Infants exclusively fed with formula.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teté Dance Intervention
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
A culturally tailored behavioral intervention combining physical activity and community engagement to support breastfeeding practices.
No Intervention: Standard Breastfeeding Support
Participants in this group will receive standard breastfeeding support as provided by usual care practices, without any additional interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days from intervention start date.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crianzamor

Investigators

  • Principal Investigator: Javier H Ravichagua Ashiyama, MD, Crianzamor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Actual)

January 28, 2023

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

December 20, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 26, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202400018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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