Clinical trial NCT06751186: Effect of Teté Dance on Breastfeeding Duration in Irritable Infants
Official title: Effect of 'Teté Dance' on the Duration of the Lactation Session in Irritable Infants in Peru: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding Duration
Infant Feeding Practices
Keywords: Breastfeeding Duration
Irritable Infants
Maternal Support
Teté Dance Intervention
Breastfeeding Practices
Cultural Lactation Support
Infant Nutrition
Lead sponsor: Crianzamor
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breastfeeding Session Duration
timeFrame: 7 days from intervention start date.
Secondary outcomes:
Other outcomes:
Locations:
city: Piura
country: Peru
facility: Crianzamor
Study officials:
affiliation: Crianzamor
name: Javier H Ravichagua Ashiyama, MD
role: PRINCIPAL_INVESTIGATOR
References:
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