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

NCT ID: NCT06195358

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2026-07-31

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. 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.

Detailed 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.

Conditions

Infant Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Arm

The control arm will receive printed caregiving materials.

Group Type: ACTIVE_COMPARATOR

Printed Caregiving Materials

Intervention Type: 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.

Intervention Arm

The intervention arm will receive the smartphone application.

Group Type: EXPERIMENTAL

Mobile Health (Smartphone) Application

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital, Boston USA

UNKNOWN

Sponsor Role: collaborator

Wuqu' Kawoq - Maya Health Alliance, Tecpán Guatemala

UNKNOWN

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Beth Smith

Associate Professor of Pediatrics (USC Faculty/Non Physician CWR)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beth Smith, PT, DPT, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Wuqu' Kawoq/ Maya Health Alliance

Chimaltenango, , Guatemala

Site Status: RECRUITING

Countries

Guatemala

Central Contacts

Beth Smith, PT, DPT, PhD

Role: CONTACT

bsmith@chla.usc.edu

323-361-4670

Dana Fine

Role: CONTACT

dafine@chla.usc.edu

323-356-5293

Facility Contacts

Peter Rohloff

Role: primary

hola@wuqukawoq.org

502-7840-3112

Other Identifiers

R33HD107983

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHLA-21-00168_18-month

Identifier Type: -

Identifier Source: org_study_id