The Childhood Health and Asthma Management Program

Completed · Not applicable

Conditions studied: Asthma, Obesity, Family, Child

In brief

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. Weight loss reduces asthma symptoms, improves lung function, and increases quality of life among OV/OB adults with asthma. Little research has examined the impact of weight loss on asthma outcomes in OV/OB youth, and there is little research examining weight management interventions in OV/OB children with asthma. Behavioral family-based lifestyle interventions are successful in producing weight loss in children. To our knowledge, however, there has been no systematic effort to examine the impact of these interventions on weight status and asthma outcomes, nor has there been an effort to tailor these programs to the specific needs of OV/OB children with asthma. The aims of this study are to develop and test the Childhood Health and Asthma Management Program (CHAMP), a behavioral family-based lifestyle intervention that is community-based to promote successful weight and asthma management in OV/OB children with asthma. The investigators propose to develop an intervention based on a previously developed behavioral family-based lifestyle intervention that was community-based and produced positive long term weight status changes in OV/OB children and tailor it for OV/OB children with asthma to create CHAMP. CHAMP will include asthma education and targeting unique barriers to weight management in OV/OB children with asthma. A focus group will be conducted with OV/OB children with asthma, ages 6-12, and their parent(s). Then a pilot randomized controlled trial of the CHAMP intervention with 32 OV/OB children with asthma, ages 6-12 years, and their parent(s). Families will be randomly assigned to CHAMP or a health education group. The investigators hypothesize that participants in CHAMP will have more effective weight and asthma management and child asthma outcomes compared to those in the general education group.

Key facts

Study ID: NCT02303561
Run by: University of Florida
People needed: 56
Starts: 2014-06-01
Expected to finish: 2017-03-13
Last updated by the study team: 2017-05-17

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.