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Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Infant Development Clinical Trial

Official title:
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Clinical Trial Summary

Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. This overall study is designed to explore this idea, by designing a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala in providing nurturing care and, after design, to conduct a prospective implementation trial of its use followed by an adequately-powered efficacy study.

Clinical Trial Description

Rationale: According to recent estimates, 43% of children under age 5 residing in low- and middle-income countries (LMICs)-250 million children in total-are at risk of not reaching their developmental potential due to living in environments with malnutrition, poverty, and lack of early stimulation. Mobile health (mHealth) technology represents an efficient strategy for scaling interventions to promote infant development. Intervention: Pilot randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 6 months. Objectives and purpose: We will test a smartphone application that will directly engage caregivers in providing nurturing care to at-risk infants. We will assess effectiveness of the mHealth application compared to paper caregiving materials by establishing effect sizes of group differences in Bayley scores after 6 months. Study population: parents of newborn infants, newborn infants. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05106894
Study type Interventional
Source Children's Hospital Los Angeles
Contact
Status Active, not recruiting
Phase N/A
Start date January 11, 2023
Completion date August 31, 2024
View Details
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