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:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT03900312
Eligibility Criteria:
Inclusion Criteria (Caregivers):
* Female \> 18 years of age
* Self-identify as Navajo
* Be a caregiver of a girl 8-11 years old who is available to enroll in the study
* Living within 50 miles of the Chinle (Tsaile or Pinon are also included) or Tuba City, Arizona Johns Hopkins program offices
* Willing to participate in the preconception health program
* Willing to complete all implementation and follow-up assessment
* Speaks and reads English
* Not cognitively or visually impaired (able to complete questionnaires)
* Review and sign informed consent
Inclusion Criteria (Child):
* Female, 8-11 years old
* Have a caregiver enrolled in the study
* Living within 50 miles of the Chinle (Tsaile or Pinon are also included) or Tuba City, Arizona Johns Hopkins program offices
* Willing to participate in the preconception health program
* Willing to complete all implementation and follow-up assessments
* Speaks and reads English
* Not cognitively or visually impaired (able to complete questionnaires)
* Review and sign a study assent and have a parent/guardian sign parental permission
Exclusion Criteria (child and caregiver):
* Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, cognitive impairment, etc.)
* Due to potential mobility of foster children, children in foster care are excluded from the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
8 Years
Study:
NCT03900312
Study Brief:
Protocol Section:
NCT03900312