Infant DevelopmentNCT05106894
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
A study testing smartphone application to promote nurturing care and printed caregiving materials in people with Infant Development, run by Children's Hospital Los Angeles at 1 site in Guatemala.
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'… Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- smartphone application to promote nurturing care and printed caregiving materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGuatemala
- Study dates
- 11 Jan 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Infant Development
- Being tested
- smartphone application to promote nurturing care, printed caregiving materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone application to promote nurturing careBehavioural
see arm description
printed caregiving materialsBehavioural
see arm description
| Study group | Role | What they receive |
|---|---|---|
| smartphone application to promote nurturing care | Experimental | a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care Receives: Behavioral: smartphone application to promote nurturing care |
| printed caregiving materials | Active comparator | caregivers will receive print materials on early childhood stimulation Receives: Behavioral: printed caregiving materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE
Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.
Measured: 6 months
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR
Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.
Measured: 6 months
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE
Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start11 Jan 2023
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Wuqu' Kawoq, Maya Health Alliance, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Beth Smith, Children's Hospital Los Angeles
- Investigators
- Beth A Smith, PT, DPT, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106894
- Sponsor's protocol ID
- CHLA-21-00168
- Other IDs
- 5R21HD107983
- Status last verified
- May 2025
- First submitted
- 25 Oct 2021
- Last updated
- 28 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified data will be shared via NICHD DASH
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
- ClinicalTrials.gov ID
- NCT05106894
- Acronym / sponsor ID
- CHLA-21-00168
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Wuqu' Kawoq, Maya Health Alliance, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Posted 28 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| smartphone application to promote nurturing care | Experimental | Behavioral: smartphone application to promote nurturing carea caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care |
| printed caregiving materials | Active comparator | Behavioral: printed caregiving materialscaregivers will receive print materials on early childhood stimulation |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smartphone application to promote nurturing caresee arm description | Behavioural | smartphone application to promote nurturing care |
| printed caregiving materialssee arm description | Behavioural | printed caregiving materials |
Primary outcome
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE
Time frame: 6 months
Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR
Time frame: 6 months
Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE
Time frame: 6 months
Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. de-identified data will be shared via NICHD DASH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth A Smith, PT, DPT, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone application to promote nurturing care and printed caregiving materials in people with Infant Development, run by Children's Hospital Los Angeles at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.