Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT05106894
Status:
COMPLETED
Last Update Posted:
2025-05-28
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Sponsor:
Children's Hospital Los Angeles
Organization:
Study Overview
Official Title:
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R21HD107983 | NIH | None | https://reporter.nih.gov/quic… | View |