The Childhood Health and Asthma Management Program

NCT02303561 | Completed

• 1 other identifier: IRB201400235
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Obesity; Family; Child

Outcome Measures

Primary Outcomes (1)

• Spirometry will be used to test the change in lung function from baseline, 4 months, and 10 months

  Change from Baseline, 4 months, and 10 months

Secondary Outcomes (6)

• Body Mass Index will be calculated to test the change in weight 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

  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.

  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.

  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.

  Change from Baseline, 4 months, and 10 months

Study Arms (2)

CHAMP

EXPERIMENTAL

Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.

Behavioral: CHAMP

Health education

ACTIVE COMPARATOR

Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.

Behavioral: Health education

Interventions

CHAMP BEHAVIORAL

Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.

CHAMP

Health education BEHAVIORAL

Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.

Health education

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of Florida: lead
• American Lung Association: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Asthma; Obesity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David A Fedele, Ph.D>

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: June 1, 2014
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: May 17, 2017

Record last verified: 2017-05

Locations

US (1)