Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

The Childhood Health and Asthma Management Program (CHAMP)

16 maggio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

56

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • University of Florida

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 12 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
Comportamentale: CHAMP
Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
Comparatore attivo: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
Comportamentale: Health education
Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Spirometry will be used to test the change in lung function from baseline, 4 months, and 10 months
Lasso di tempo: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Body Mass Index will be calculated to test the change in weight from baseline, 4 months, and 10 months
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: Change from Baseline, 4 months, and 10 months
Change from Baseline, 4 months, and 10 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Florida

Collaboratori

American Lung Association

Investigatori

  • Investigatore principale: David A Fedele, Ph.D>, University of Florida

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2014

Completamento primario (Effettivo)

13 marzo 2017

Completamento dello studio (Effettivo)

13 marzo 2017

Date di iscrizione allo studio

Primo inviato

25 novembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

25 novembre 2014

Primo Inserito (Stima)

1 dicembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB201400235

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su CHAMP

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Czech Republic

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi