Clinical trial NCT06195358: Mobile Health Intervention for Infants in Guatemala (18-m Intervention)
Official title: Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Development
Keywords: early childhood development
LMIC
Guatemala
mHealth
smartphone
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital, Boston USA
name: Wuqu' Kawoq - Maya Health Alliance, Tecpán Guatemala
First posted: 2024-01-08
Enrollment: 220
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference between study arms in Composite Language Score
timeFrame: 18 months
measure: Difference between study arms in Composite Motor Score
timeFrame: 18 months
measure: Difference between study arms in Composite Cognitive Score
timeFrame: 18 months
Secondary outcomes:
measure: Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score
timeFrame: Change from 0 to 18 months
Other outcomes:
Locations:
city: Chimaltenango
country: Guatemala
facility: Wuqu' Kawoq/ Maya Health Alliance
Study officials:
affiliation: Children's Hospital Los Angeles
name: Beth Smith, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: