Clinical trial NCT05106894: Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Official title: Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: Wuqu' Kawoq, Maya Health Alliance
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-11-04
Enrollment: 41
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE
timeFrame: 6 months
measure: Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR
timeFrame: 6 months
measure: Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chimaltenango
country: Guatemala
facility: Wuqu' Kawoq/ Maya Health Alliance
Study officials:
affiliation: Children's Hospital Los Angeles
name: Beth A Smith, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References: