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. 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.

Study Overview

• Status: Completed
• Conditions: Infant Development
• Intervention / Treatment: Behavioral: smartphone application to promote nurturing care; Behavioral: printed caregiving materials

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: newborn infants.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (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
Experimental: smartphone application to promote nurturing care; a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care	Behavioral: smartphone application to promote nurturing care; see arm description
Active Comparator: printed caregiving materials; caregivers will receive print materials on early childhood stimulation	Behavioral: printed caregiving materials; see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE	Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.	6 months
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR	Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.	6 months
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE	Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CHLA-21-00168; 5R21HD107983 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified data will be shared via NICHD DASH
• IPD Sharing Time Frame: data will become available upon completion of the study and will remain available indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No