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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT02303561
Eligibility Criteria:
Inclusion Criteria:
* speaks English;
* has a physician-verified persistent asthma diagnosis or by indicating on a screening questionnaire that they
1. having a current prescription for a controller medication (e.g. Fluticasone), or
2. demonstrating any of the following symptom frequency in the previous month: (I) daytime asthma symptoms more than two days a week, (II) nighttime awakenings due to asthma more than times a month, (III) short-acting beta agonist use 2 days a week, (IV) normal activity limitation, (V) oral steroid use 2 times a year, (VI) emergency department visit due to asthma in past year;
* has a BMI at or above the 85th percentile for age and gender norms as published by the CDC.
Participating parents of legal guardians must:
* live in the same home with the child;
* speak English;
* be aged 75 or younger. There is no BMI requirement for participating parents/legal guardians.
Exclusion Criteria:
* child or parent has dietary restriction or a medical condition that contraindicates mild energy restriction or physical activity (history of musculo-skeletal condition that limits walking, heart condition, chronic lung diseases limiting physical activity, current participation in commercial weight loss program);
* use of antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids within 3 months, or prescription weight loss drugs within 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT02303561
Study Brief:
Protocol Section:
NCT02303561