NCT06195358

Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 4 Weeks
• 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. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.

Detailed description

Rationale: According to recent estimates, nore than 40% 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: Individually-randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 18 months. Objectives and purpose: We will test the effectiveness of 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 comparing group differences in Bayley scores after 18 months. Study population: first-time parents of newborn infants, newborn infants.

Conditions

• Infant Development

Interventions

Type	Name	Description
DEVICE	Mobile Health (Smartphone) Application	The intervention arm will receive the smartphone application, which has been designed to engage primary caregivers directly in the active monitoring of their infants' development, and to provide tailored feedback and support for the provision of nurturing care. Study staff will make an initial home visit (less than an hour) to install the application on the caregiver phone and demonstrate use and collect baseline data. Subsequently, in the intervention arm, staff will make monthly visits (approximately 15 minutes duration) to assess functionality of the smartphone and answer questions/reinforce use.
OTHER	Printed Caregiving Materials	The control arm will receive printed caregiving materials. In the control arm, staff will make monthly visits (approximately 15 minutes duration) to ask if there are questions about the printed caregiving materials.

Timeline

• Start date: 2024-01-25
• Primary completion: 2026-05-31
• Completion: 2026-07-31
• First posted: 2024-01-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: Guatemala