Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Study 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. 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.

Detailed 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: parents of newborn infants, newborn infants.

Official Title
-----------------
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Conditions
-----------------
Infant Development

Intervention / Treatment
-----------------
* Behavioral: smartphone application to promote nurturing care
* Behavioral: printed caregiving materials


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smartphone application to promote nurturing care<br>a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care | Behavioral: smartphone application to promote nurturing care<br>* see arm description<br>|
| Active Comparator: printed caregiving materials<br>caregivers will receive print materials on early childhood stimulation | Behavioral: printed caregiving materials<br>* see arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect size of group differences in Bayley scores after 6 months | Bayley Scales of Infant and Toddler Development (3rd edition). Scores are norm-referenced based on age. Higher scores are better. | 6 months |