NCT05106894

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed 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: newborn infants.

Conditions

• Infant Development

Interventions

Type	Name	Description
BEHAVIORAL	smartphone application to promote nurturing care	see arm description
BEHAVIORAL	printed caregiving materials	see arm description

Timeline

• Start date: 2023-01-11
• Primary completion: 2024-08-31
• Completion: 2024-08-31
• First posted: 2021-11-04
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

1 site across 1 country: Guatemala