N/A
Completed N=41
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Infant Development
Source: ClinicalTrials.gov NCT05106894 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE — 111; 111 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE |
111; 111 | — |
| PRIMARY Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR |
105; 106 | — |
| PRIMARY Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE |
104; 104 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05106894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.