Mobile Health Intervention for Infants in Guatemala (18-m Intervention)
- Conditions
- Infant Development
- Interventions
- Device: Mobile Health (Smartphone) ApplicationOther: Printed Caregiving Materials
- Registration Number
- NCT06195358
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Arm Mobile Health (Smartphone) Application The intervention arm will receive the smartphone application. Control Arm Printed Caregiving Materials The control arm will receive printed caregiving materials.
- Primary Outcome Measures
Name Time Method Difference between study arms in Composite Language Score 18 months Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153
Difference between study arms in Composite Motor Score 18 months Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154
Difference between study arms in Composite Cognitive Score 18 months Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145
- Secondary Outcome Measures
Name Time Method Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score Change from 0 to 18 months Raw score range 0-45, higher scores better
Trial Locations
- Locations (1)
Wuqu' Kawoq/ Maya Health Alliance
🇬🇹Chimaltenango, Guatemala