Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

NCT05106894 | Completed Results

• 2 other identifiers: CHLA-21-001685R21HD107983
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

smartphone application to promote nurturing care

EXPERIMENTAL

a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care

Behavioral: smartphone application to promote nurturing care

printed caregiving materials

ACTIVE COMPARATOR

caregivers will receive print materials on early childhood stimulation

Behavioral: printed caregiving materials

Interventions

smartphone application to promote nurturing care BEHAVIORAL

see arm description

smartphone application to promote nurturing care

printed caregiving materials BEHAVIORAL

see arm description

printed caregiving materials

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• Wuqu' Kawoq, Maya Health Alliance: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Wuqu' Kawoq/ Maya Health Alliance

Chimaltenango, Guatemala

Location

Results Point of Contact

• Title: Dr. Beth A. Smith
• Organization: Children's Hospital Los Angeles

bsmith@chla.usc.edu

3233614670

Study Officials

• Beth A Smith, PT, DPT, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: January 11, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: May 28, 2025
• Results First Posted: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will become available upon completion of the study and will remain available indefinitely.

Locations

GU (1)