Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Children's Hospital Los Angeles

Status: Completed

Conditions: Infant Development

Treatments: Behavioral: smartphone application to promote nurturing care; Behavioral: printed caregiving materials

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05106894

CHLA-21-00168

5R21HD107983 (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. 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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: Under 6 months 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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41 participants in 2 patient groups

smartphone application to promote nurturing care

Experimental group

Description:

a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care

Treatment:

Behavioral: smartphone application to promote nurturing care

printed caregiving materials

Active Comparator group

Description:

caregivers will receive print materials on early childhood stimulation

Treatment:

Behavioral: printed caregiving materials