Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-11

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06195358

Infant Development

RECRUITING NA

Perinatal mHealth Intervention in Guatemala

NCT02348840

Pregnancy Prenatal Care

COMPLETED NA

Healthy Baby Healthy Mother Toolkit

NCT06594419

Maternal Nutrition Child Nutrition

RECRUITING NA

Effect of a Mobile Health Intervention on Birth Outcome and Infant Health

NCT06431581

Birth Outcomes Infant Health

RECRUITING NA

Postnatal mHealth Intervention Development

NCT04636398

Health Attitude Knowledge, Attitudes, Practice Postpartum Depression +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

smartphone application to promote nurturing care

a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care

Group Type EXPERIMENTAL

smartphone application to promote nurturing care

Intervention Type BEHAVIORAL

see arm description

printed caregiving materials

caregivers will receive print materials on early childhood stimulation

Group Type ACTIVE_COMPARATOR

printed caregiving materials

Intervention Type BEHAVIORAL

see arm description

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

smartphone application to promote nurturing care

see arm description

Intervention Type BEHAVIORAL

printed caregiving materials

see arm description

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes