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Active, Not Recruiting

NCT Number: NCT06195358

Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

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. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infant Development

Age range

Up to 4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuqu' Kawoq/ Maya Health Alliance

Chimaltenango, Departamento de Chimaltenango, Guatemala

About this study

Rationale: According to recent estimates, nore than 40% 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: Individually-randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 18 months.

Objectives and purpose: We will test the effectiveness of 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 comparing group differences in Bayley scores after 18 months.

Study population: first-time parents of newborn infants, newborn infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Health (Smartphone) Application

Device

The intervention arm will receive the smartphone application, which has been designed to engage primary caregivers directly in the active monitoring of their infants' development, and to provide tailored feedback and support for the provision of nurturing care. Study staff will make an initial home visit (less than an hour) to install the application on the caregiver phone and demonstrate use and collect baseline data. Subsequently, in the intervention arm, staff will make monthly visits (approximately 15 minutes duration) to assess functionality of the smartphone and answer questions/reinforce use.

Printed Caregiving Materials

Other

The control arm will receive printed caregiving materials. In the control arm, staff will make monthly visits (approximately 15 minutes duration) to ask if there are questions about the printed caregiving materials.

Primary outcomes

  1. Difference between study arms in Composite Language Score

    Time frame: 18 months

    Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153

  2. Difference between study arms in Composite Motor Score

    Time frame: 18 months

    Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154

  3. Difference between study arms in Composite Cognitive Score

    Time frame: 18 months

    Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145

Secondary outcomes

  1. Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score

    Time frame: Change from 0 to 18 months

    Raw score range 0-45, higher scores better

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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