The Childhood Health and Asthma Management Program (CHAMP)

May 16, 2017 updated by: University of Florida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
Behavioral: CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
Active Comparator: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
Behavioral: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spirometry will be used to test the change in lung function from baseline, 4 months, and 10 months
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index will be calculated to test the change in weight from baseline, 4 months, and 10 months
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Asthma Control Test questionnaire will be calculated to test the change in asthma control from baseline, 4 months, and 10 months
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Family Asthma Management System Scale semi-structured interview will be used to test the change in family asthma management from baseline, 4 months, and 10 months.
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Standardised Paediatric Asthma Quality of Life Questionnaire interview will be used to test the change in quality of life from baseline, 4 months, and 10 months.
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
The Block Foods questionnaire will be used to test the change in dietary intake from baseline, 4 months, and 10 months.
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months
Objectively monitored physical activity will be used to test the change in physical activity from baseline, 4 months, and 10 months.
Time Frame: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

American Lung Association

Investigators

  • Principal Investigator: David A Fedele, Ph.D>, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

March 13, 2017

Study Completion (Actual)

March 13, 2017

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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