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:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT03529695
Eligibility Criteria:
\*Important: Mother (or caregiver) and child dyads are enrolled together. Both must meet inclusion criteria to participate.
Inclusion Criteria:
Mothers:
* Enrolled in a partnered home visitation program
* Mother or primary caregiver of 2-8 month old child
* BMI above 18.5
* Generally Healthy
Children:
* 2-8 months of age at time of enrollment
* Parent or primary caregiver receiving home visitation services
Exclusion Criteria:
Mothers:
* Any history of an eating or feeding disorder, or obesity related syndrome (such as Prader-Willi)
* Diagnosis of Schizophrenia
* Currently enrolled in a diet and weight loss program, AND either a) significant weight loss of 10+ pounds in the last 6 months, OR b) unwilling to discontinue from current diet and weight loss program.
Infants:
* Infant is clinically underweight (\<5th percentile) or has a history of a feeding or eating disorder
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
2 Months
Study:
NCT03529695
Study Brief:
Protocol Section:
NCT03529695