Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04042467
Eligibility Criteria:
Inclusion Criteria:
For this study, eligible caregiver/infant dyads will be those with:
1. an English- or Spanish-speaking parent/legal guardian,
2. infant born in the newborn nursery with plans to have care in the local clinic OR presenting in that clinic for the first newborn visit (1-21 days of life),
3. attendance at first newborn clinic visit
4. no plans to leave the clinic within 2 years
5. Completion of baseline data collection (survey data, child weight and length measures prior to randomization).
6. Own a smartphone with access to data services
Exclusion Criteria:
Infant exclusion criteria:
1. born prior to 34 weeks gestation or birth weight \<1500 grams; weight \<3rd %tile at enrollment (World Health Organization growth curves); or
2. any chronic medical problem that may affect weight gain (e.g., metabolic disease, uncorrected congenital heart disease, renal disease, high-calorie formula; cleft palate; Down syndrome).
Caregiver exclusion criteria include:
1. \<18 years old;
2. serious mental or neurologic illness that impairs ability to consent/participate;
3. poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener).
4. biological mother is HIV-positive
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
21 Days
Study:
NCT04042467
Study Brief:
Protocol Section:
NCT04042467