Status:
COMPLETED
The Childhood Health and Asthma Management Program
Lead Sponsor:
University of Florida
Collaborating Sponsors:
American Lung Association
Conditions:
Asthma
Obesity
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Overweight and obese (OV/OB) children with asthma are at-risk for particularly poor health outcomes including poor asthma control, higher risk of asthma-related symptoms, and decreased quality of life...
Detailed Description
At the first appointment the following information will be collected to determine eligibility for the research study. If participation is determined, a second visit will be scheduled at the end of the...
Eligibility Criteria
Inclusion
- speaks English;
- has a physician-verified persistent asthma diagnosis or by indicating on a screening questionnaire that they
- having a current prescription for a controller medication (e.g. Fluticasone), or
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02303561
Start Date
June 1 2014
End Date
March 13 2017
Last Update
May 17 2017
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610