- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02303561
The Childhood Health and Asthma Management Program (CHAMP)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- University of Florida
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 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.
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: CHAMP
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 behavioral skills focused on improving asthma and weight management.
|
Comparador Ativo: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
|
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
Spirometry will be used to test the change in lung function from baseline, 4 months, and 10 months
Prazo: Change from Baseline, 4 months, and 10 months
|
Change from Baseline, 4 months, and 10 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Body Mass Index will be calculated to test the change in weight from baseline, 4 months, and 10 months
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: Change from Baseline, 4 months, and 10 months
|
Change from Baseline, 4 months, and 10 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David A Fedele, Ph.D>, University of Florida
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB201400235
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em CHAMP
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Children's Mercy Hospital Kansas CityThe Gerber FoundationInscrevendo-se por conviteAlimentação e Transtornos Alimentares da Infância | Gastrostomia | Distúrbio Alimentar da Infância e da InfânciaEstados Unidos
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Lori EricksonInscrevendo-se por conviteDefeitos Cardíacos Congênitos | PediatriaEstados Unidos
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Children's Mercy Hospital Kansas CityThe Gerber FoundationInscrevendo-se por convite
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University of TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Unity HealthAinda não está recrutandoCâncer | Adultos mais velhos
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University Health Network, TorontoRecrutamentoCâncer | Adultos mais velhosCanadá
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Indiana UniversityNational Institute on Aging (NIA)ConcluídoDelírio | Comprometimento CognitivoEstados Unidos