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

Infant Development Clinical Trial

Official title:

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06195358
• Other study ID #: CHLA-21-00168_18-month
• Secondary ID: R33HD107983
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: February 2024
• Source: Children's Hospital Los Angeles
• Contact: Beth Smith, PT, DPT, PhD
• Phone: 323-361-4670
• Email: bsmith[@]chla.usc.edu
• 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. 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Weeks

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

Device:
• Mobile Health (Smartphone) Application
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.

Other:
• Printed Caregiving Materials
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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Brigham and Women's Hospital, Boston USA, Wuqu' Kawoq - Maya Health Alliance, Tecpán Guatemala

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between study arms in Composite Language Score	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153	18 months
Primary	Difference between study arms in Composite Motor Score	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154	18 months
Primary	Difference between study arms in Composite Cognitive Score	Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145	18 months
Secondary	Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score	Raw score range 0-45, higher scores better	Change from 0 to 18 months