Official Title
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
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 providenurturing care is an evidence-based strategy, however feasibility of scaling-up thissupporting is limited by competing demands on health workers' time. For infantdevelopment, mHealth technologies have the potential to solve this problem by providingtailored content directly to caregivers, involving and empowering them to promote infantdevelopment, promoting and facilitating interactions with health workers when areas ofconcern are identified and, therefore, expanding the reach of healthcare systems.Following a pilot feasibility study, this current study will examine the effectiveness ofa caregiver-directed smartphone application to directly engage first-time caregivers inrural 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.

Recruiting
Infant Development

Device: Mobile Health (Smartphone) Application

The intervention arm will receive the smartphone application, which has been designed to
engage primary caregivers directly in the active monitoring of their infants'
development, and to provide tailored feedback and support for the provision of nurturing
care. Study staff will make an initial home visit (less than an hour) to install the
application on the caregiver phone and demonstrate use and collect baseline data.
Subsequently, in the intervention arm, staff will make monthly visits (approximately 15
minutes duration) to assess functionality of the smartphone and answer
questions/reinforce use.

Other: Printed Caregiving Materials

The control arm will receive printed caregiving materials. In the control arm, staff will
make monthly visits (approximately 15 minutes duration) to ask if there are questions
about the printed caregiving materials.

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

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: 4 Weeks
Countries
Guatemala
Locations

Wuqu' Kawoq/ Maya Health Alliance
Chimaltenango, Guatemala

Investigator: Peter Rohloff
Contact: 502-7840-3112
hola@wuqukawoq.org

Contacts

Beth Smith, PT, DPT, PhD
323-361-4670
bsmith@chla.usc.edu

Dana Fine
323-356-5293
dafine@chla.usc.edu

Beth Smith, PT, DPT, PhD, Principal Investigator
Children's Hospital Los Angeles

Children's Hospital Los Angeles
NCT Number
Keywords
early childhood development
LMIC
Guatemala
mHealth
smartphone