Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Overview
- Phase
- N/A
- Intervention
- Printed Caregiving Materials
- Conditions
- Infant Development
- Sponsor
- Children's Hospital Los Angeles
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Difference between study arms in Composite Language Score
- Status
- Recruiting
- Last Updated
- last month
Overview
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.
Investigators
Beth Smith
Associate Professor of Pediatrics (USC Faculty/Non Physician CWR)
Children's Hospital Los Angeles
Eligibility Criteria
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
Arms & Interventions
Control Arm
The control arm will receive printed caregiving materials.
Intervention: Printed Caregiving Materials
Intervention Arm
The intervention arm will receive the smartphone application.
Intervention: Mobile Health (Smartphone) Application
Outcomes
Primary Outcomes
Difference between study arms in Composite Language Score
Time Frame: 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
Time Frame: 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
Time Frame: 18 months
Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145
Secondary Outcomes
- Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score(Change from 0 to 18 months)