MedPath

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Not Applicable
Completed
Conditions
Infant Development
Registration Number
NCT05106894
Lead Sponsor
Children's Hospital Los Angeles
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
41
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE6 months

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.

Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR6 months

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.

Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE6 months

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Wuqu' Kawoq/ Maya Health Alliance

🇬🇹

Chimaltenango, Guatemala

Wuqu' Kawoq/ Maya Health Alliance
🇬🇹Chimaltenango, Guatemala

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