Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-02-19 @ 9:01 PM
Study NCT ID:
NCT02303561
Status:
COMPLETED
Last Update Posted:
2017-05-17
First Post:
2014-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Childhood Health and Asthma Management Program
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
The Childhood Health and Asthma Management Program
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHAMP
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. 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.
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.
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 visit or the potential participant will be provided with a suggestion to speak with their primary care physician for other treatment options.
A measurement of height and weight will be taken, questionnaires regarding medical history, including asthma symptoms and control, and questionnaires about family background information (e.g., family income, size of family, employment, and marital status).
In addition, information concerning the following conditions will be collected and may exclude participation: dietary restriction or a medical condition that makes mild energy restriction or physical activity potentially dangerous, diagnosed with a major psychiatric disorder such as schizophrenia, bipolar disorder or autism, has used systemic corticosteroids within 3 months, or prescription weight loss drugs within 6 months.
The second appointment will happen one to two weeks before the start of the treatment program. During this visit the following will happen:
A measurement of height and weight, and waistline, questionnaires and complete an interview about asthma management and quality of life, and a test for lung function both pre and post albuterol. At the end of the visit an accelerometer will be provided to wear for 7 days in a row. The accelerometer will measure how much exercise is done each day.
At the end of this visit, the participant will be randomly assignment to either the experimental Childhood Health and Asthma Management Program (CHAMP) group or the health education group.
The CHAMP group will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
The health education group will receive tailored asthma education and general health education on a variety of topics.
Each of the treatment programs will last for 6 months.
A measurement of height and weight will be taken, questionnaires regarding medical history, including asthma symptoms and control, and questionnaires about family background information (e.g., family income, size of family, employment, and marital status).
In addition, information concerning the following conditions will be collected and may exclude participation: dietary restriction or a medical condition that makes mild energy restriction or physical activity potentially dangerous, diagnosed with a major psychiatric disorder such as schizophrenia, bipolar disorder or autism, has used systemic corticosteroids within 3 months, or prescription weight loss drugs within 6 months.
The second appointment will happen one to two weeks before the start of the treatment program. During this visit the following will happen:
A measurement of height and weight, and waistline, questionnaires and complete an interview about asthma management and quality of life, and a test for lung function both pre and post albuterol. At the end of the visit an accelerometer will be provided to wear for 7 days in a row. The accelerometer will measure how much exercise is done each day.
At the end of this visit, the participant will be randomly assignment to either the experimental Childhood Health and Asthma Management Program (CHAMP) group or the health education group.
The CHAMP group will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
The health education group will receive tailored asthma education and general health education on a variety of topics.
Each of the treatment programs will last for 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: