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

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Infant Development

Treatments: Other: Printed Caregiving Materials; Device: Mobile Health (Smartphone) Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06195358

CHLA-21-00168_18-month

R33HD107983 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: Under 4 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• first-time caregivers with an infant in the eligible age range (0-4 weeks)
• infant from singleton birth
• infant from full-term (> 37 weeks gestation) birth

Exclusion criteria

• Presence of acute malnutrition/wasting or severe medical illness (heart disease, kidney disease, congenital abnormality) in the infant
• medical need for supplementation of breastfeeding
• caregiver not literate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

The control arm will receive printed caregiving materials.

Treatment:

Other: Printed Caregiving Materials

Intervention Arm

Experimental group

Description:

The intervention arm will receive the smartphone application.

Treatment:

Device: Mobile Health (Smartphone) Application