Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Other: Printed Caregiving Materials; Device: Mobile Health (Smartphone) Application

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 (primary outcome = language composite score).

Study population: first-time parents of newborn infants, newborn infants.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Departamento de Chimaltenango
    • Chimaltenango, Departamento de Chimaltenango, Guatemala
      • Wuqu' Kawoq/ Maya Health Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; The control arm will receive printed caregiving materials.	Other: Printed Caregiving Materials; The control arm will receive printed caregiving materials. In the control arm, staff will make visits every 3 months (approximately 15 minutes duration) to ask if there are questions about the printed caregiving materials.
Experimental: Intervention Arm; The intervention arm will receive the smartphone application.	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 visits every 3 months (approximately 15 minutes duration) to assess functionality of the smartphone and answer questions/reinforce use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between study arms in Composite Language Score	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between study arms in Composite Motor Score	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154	18 months
Difference between study arms in Composite Cognitive Score	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145	18 months
Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score	Raw score range 0-45, higher scores better	Change from 0 to 18 months
Change in the Nursing Child Assessment Satellite Training (NCAST) Feeding Scale Total Score	Raw score, higher scores better	Change from 0 to 18 months

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Beth Smith, PT, DPT, PhD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Actual): August 21, 2026
• Study Completion (Actual): August 21, 2026

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: December 22, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: smartphone; mHealth; LMIC; Guatemala; early childhood development
• Other Study ID Numbers: CHLA-21-00168_18-month; R33HD107983 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the published results will be deposited in a publicly accessible data repository.
• IPD Sharing Time Frame: Data will become available upon completion of the study and publication of primary paper and will remain available indefinitely.
• IPD Sharing Access Criteria: De-identified data will be available to all requestors according to the access procedures of the selected repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No