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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT05013359
Eligibility Criteria:
Inclusion Criteria for Adolescents living with obesity:
* Informed consent obtained by parent/legal guardian and ALwO before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, aged 12 to less than 18 years at the time of signing informed consent.
* Lives in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan.
* Has a current BMI-for-age (based on self-reported sex, age, height, and weight) greater than or equal to 95th percentile for age and sex based on charts appropriate locally for the country of residence.
Inclusion Criteria for Caregivers of Adolescents living with obesity:
* Informed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above or equal to 24 years at the time of signing informed consent.
* Lives in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan.
* Has an adolescent in the household with a current BMI-for-age (based on self-reported sex, age, height, and weight) greater than or equal to 95th percentile for age and sex based on charts appropriate locally for the country of residence.
* Resides in the same household as the ALwO at least 50% of the time.
* Is involved in the healthcare decisions of the ALwO.
Inclusion Criteria for Health Care Providers:
* Informed consent before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Is a physician.
* Practices in one of the participating countries: Italy, Spain, UK, Mexico, Colombia, Australia, Saudi Arabia, Turkey, South Korea, and Taiwan
* In clinical practice more than or equal to 2 years.
* Spends at least 50% of time in direct patient care.
* Has seen/treated at least ten adolescent patients (age 12 to less than 18 years) with obesity in a typical month (defined as BMI-for-age greater than or equal to 95th percentile for age and sex based on charts appropriate locally for the country of residence).
Exclusion Criteria for Adolescents living with obesity:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
* Has had significant weight loss or weight gain due to major injury or illness/condition (e.g., cancer, accident, pregnancy) in the past 6 months.
* Considers themselves to be extremely muscular.
Exclusion Criteria for Caregivers of Adolescents living with obesity:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
* ALwO they care for has had significant weight loss or weight gain due to major injury or illness/condition (e.g., cancer, accident, pregnancy) in the past 6 months.
* Considers the ALwO they care for to be extremely muscular.
Exclusion Criteria for Health Care Providers:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Mental incapacity, unwillingness, inability, or language barriers precluding adequate understanding or cooperation.
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05013359
Study Brief:
Protocol Section:
NCT05013359