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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT05551650
Eligibility Criteria:
All participants will be recruited from two existing cohorts: The Effects of Natural Sugars in Breast Milk on Healthy Infant Growth and Development (NCT04434027) and Improving the Eating Habits of Mother and Her Infant Via Sugar Reduction (MAMITA) (NCT03141346). Children and their mother's will be eligible for this study at child 6 years of age.
Initial Inclusion Criteria:
* Mother's normal weight or overweight/obesity prior to pregnancy
* Mother's who self identify as Hispanic
* Mother's who are first-time moms
* Mother's who have or have had singleton births
* Mothers must be able/willing to understand the procedures of the study, and must be able to read English or Spanish at a 5th grade level
Initial Exclusion Criteria:
* Physician diagnosis of a major medical illness (including type 1 or type 2 diabetes) or eating disorder in mothers
* Physical, mental, or cognitive issues that prevent participation
* Chronic use of any medication that may affect body weight or composition, insulin resistance, or lipid profiles
* Current smoking (more than 1 cigarette in the past week) or use of other recreational drugs
* Clinical diagnosis of gestational diabetes
* Pre-term/low birth weight infants, or diagnosis of any fetal abnormalities
* Mothers less than 18 years of age at the time of delivery will not be eligible as to avoid potential confounding from those subjects who might still be completing adolescent growth
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
6 Years
Study:
NCT05551650
Study Brief:
Protocol Section:
NCT05551650