The Childhood Health and Asthma Management Program
Condition: Asthma; Obesity; Family; Child
MeSH terms: Asthma
Study type: Interventional

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.
    

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.
    

Intervention name(s): CHAMP; Health education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.; Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment