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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT05334420
Eligibility Criteria:
FATHER
* Father or significant male role model (e.g. step father, grandfather, uncle, or older brother) of a child 5-11 years old
* Age 18-65 year old
* Living in Greater Houston Area
* Self-identify as Hispanic or Latino
* Able to read and write in Spanish or English
* BMI \>/=25 - 40
* Pass the 2015 American College of Sports Medicine's exercise participation health screener
CHILD
• 5-11 year old child and up to three siblings, whose father/significant male role model is participating
MOTHER (If available) 1) Significant female role model such as biological mother, step mother, foster mother, grandmother, aunt or older sister; or other co-parent/partner to participating children
Exclusion Criteria:
FATHER
* Known diagnosis of diabetes without medical clearance from health care provider;
* Known diagnosis of cardio-vascular disease (cardiac arrhythmia, h/o myocardial infarction, heart valve disease, heat failure, heart transplantation, congenital heart disease, h/o heat surgery, coronary angioplasty, or stroke)
* Currently, or in the past 6 months, in a weight management program
* Currently, or in the past 6 months, taking medicine that can affect weight or might be affected by weight loss
* Any other disease or condition affecting their ability to participate in physical activities/exercise (e.g., physical disability, severe asthma)
* Any other disease or condition affecting their ability to participate in group classroom activities including cognitive impairment (e.g., Down's syndrome, Fragile X), or psychiatric functioning (e.g. schizophrenia)
* Plans of moving away from Harris County in the next year
* Not passing the 2015 American College of Sports Medicine's exercise participation health screener AND NOT provide a medical clearance from a licensed medical provider (MD, NNP, PA)
* Unwilling to wear accelerometer for a 7 day study period at the three assessment points.
* BMI less than 25 or greater than 40.
* HbgA1C equal or greater than 6.5% at baseline data collection without medical clearance from health care provider.
* Has previously participated in studies on the Healthy Dads Healthy Kids' for US Hispanics
* History of myocarditis from COVID infection or vaccine
CHILD
* Not within the 5-11 year old child age range
* Known diagnosis of diabetes
* Known diagnosis of cardio-vascular disease (cardiac arrhythmia, h/o myocardial infarction, heart valve disease, heat failure, heart transplantation, congenital heart disease, h/o heat surgery or coronary angioplasty)
* Inability to participate in regular physical education classes in school due to health or physical condition (e.g. physical disability, severe asthma)
* Any disease or condition affecting their ability to participate in group classroom activities including cognitive impairment (e.g. Down's syndrome, Fragile X), or developmental problems (e.g. autism spectrum disorder)
* Any Known diagnosis of an eating disorder (e.g. anorexia nervosa, bulimia nervosa, etc.) MOTHER
* No father figure to her children enrolled in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
65 Years
Study:
NCT05334420
Study Brief:
Protocol Section:
NCT05334420