Trial Outcomes & Findings for Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala (NCT NCT05106894)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

6 months

Results posted on

2025-05-28

Participant Flow

Participants were recruited from January 2023 to March 2023.

Participants were infants. The Enrollment number and number of participants Started/Completed represents individual infants.

Participant milestones

Participant milestones
Measure	Smartphone Application to Promote Nurturing Care a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description	Printed Caregiving Materials caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description
Overall Study STARTED	20	21
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smartphone Application to Promote Nurturing Care n=19 Participants a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description	Printed Caregiving Materials n=21 Participants caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description	Total n=40 Participants Total of all reporting groups
Age, Continuous	20 days n=5 Participants	14 days n=7 Participants	17 days n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Maya ethnicity	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment Guatemala	19 participants n=5 Participants	21 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smartphone Application to Promote Nurturing Care n=19 Participants a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description	Printed Caregiving Materials n=20 Participants caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE	111 score on a scale Standard Deviation 9	111 score on a scale Standard Deviation 10

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smartphone Application to Promote Nurturing Care n=19 Participants a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description	Printed Caregiving Materials n=20 Participants caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR	105 score on a scale Standard Deviation 9	106 score on a scale Standard Deviation 11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Smartphone Application to Promote Nurturing Care n=19 Participants a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description	Printed Caregiving Materials n=20 Participants caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description
Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE	104 score on a scale Standard Deviation 6	104 score on a scale Standard Deviation 6

Adverse Events

Smartphone Application to Promote Nurturing Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Printed Caregiving Materials

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Beth A. Smith

Children's Hospital Los Angeles

Phone: 3233614670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place