The Childhood Health and Asthma Management Program
| Status: | Completed |
|---|---|
| Conditions: | Asthma, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 5/18/2017 |
| Start Date: | June 2014 |
| End Date: | March 13, 2017 |
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.
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.
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.
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.
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.
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