Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Infant Development Clinical Trial

Official title:

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05106894
• Other study ID #: CHLA-21-00168
• Secondary ID: 5R21HD107983
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: parents of newborn infants, newborn infants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Development

Intervention

Behavioral:
• smartphone application to promote nurturing care
see arm description
• printed caregiving materials
see arm description

Locations

Country	Name	City	State
Guatemala	Wuqu' Kawoq/ Maya Health Alliance	Chimaltenango

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Wuqu' Kawoq, Maya Health Alliance

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect size of group differences in Bayley scores after 6 months	Bayley Scales of Infant and Toddler Development (3rd edition). Scores are norm-referenced based on age. Higher scores are better.	6 months