El Sendero: Pathways to Health Study (NCT05551650) | Clinical Trial Compass
UnknownNot Applicable
El Sendero: Pathways to Health Study
United States280 participantsStarted 2021-09-01
Plain-language summary
This project will continue to follow two birth cohorts of mother-infant Latino dyads through a series of new assessments at age 6y, with an emphasis on examining the the role early nutritional exposures, exposures to environmental toxins, and social determinants of health have on adiposity, eating behaviors, brain structure and function, cognitive outcomes, and chronic disease risk.
Who can participate
Age range
6 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.