- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01930760
Supporting Physicians With Education And Know-how in Identifying and Motivating Overweight Kids (SPEAK IM OK)
Supporting Physicians With Education And Know-how in Identifying and Motivating Overweight Kids: SPEAK IM OK
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
There are no prospective, randomized clinical studies on training physicians to effectively manage pediatric obesity using both Motivational Interviewing (MI) tools and advice from overweight children. A novel aspect of this study is that the skills taught during the trainings are made so that physician can easily incorporate them into their busy practice. The generated findings from focus groups with obese children, merged guidelines for the medical management of childhood obesity, and training in specific MI tools, also make this study unique. Primary Objective:
To determine which of two interventions (behavioural/education) is most effective in increasing discussion initiation around weight with overweight children by calculating, plotting, and tracking BMI, and increasing self-reported efficacy in counseling overweight pediatric patients. HYPOTHESIS: The behaviour change intervention will be most effective because it will achieve greater changes in the above mentioned behaviours that are maintained for 6 to 12 months. These outcomes will be influenced by counselling efficacy, frequency, and type of reported barriers and not physician demographics.
Secondary Objectives:
To evaluate current physician practices of BMI calculating, plotting and/or tracking, and discussion initiation with overweight pediatric patients, and the factors that influence these behaviours. HYPOTHESIS: Physicians do not consistently calculate, plot, and/or track BMI and/or discuss weight with their pediatric patients. These practices will be primarily influenced by physicians' characteristics, counselling efficacy, frequency and type of reported barriers
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5V1X8
- The Hospital for Sick Children
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Toronto area pediatricians and family physicians who are members of the College of Physicians and Surgeons of Ontario
- Available to attend workshop at the Hospital for Sick Children
- Pediatric patient population of at least 25% (office audit to be completed by office staff) (to ensure sufficient contact with children and their families
- No sub-specialty practice in obesity or related co-morbidities (This study is aimed at changing communication in primary care offices for well-child patient visits)
Exclusion Criteria:
N/A
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Educational Intervention Group
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Educational is modeled on the Theory of Planned Action, which proposes that unless people believe that their actions can have an effect on the desired outcome they have little incentive to act or persevere in the face of difficulties. Based on this theory we will be providing physicians with information on how to calculate, plot and track BMI and how this can be associated with identification of overweight children before they present with symptoms of obesity. This intervention will attempt to demonstrate that BMI calculating, plotting and tracking are useful diagnostic monitoring tools and that their actions may lead to more effective prevention and/or treatment. The education intervention will not prescribe specific discussion initiation tools, although the participants will not be prevented from independently changing their communication behaviour. |
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Sperimentale: Behavioural Intervention Group
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The behavioural intervention will incorporate specific Motivational Interviewing (MI) tools and information from a previously completed qualitative study with obese children (Obadia et al.).
This study generated suggestions of how physicians can encourage children to think positively about making changes towards a healthier body weight.
This intervention is designed to address physicians' lack of self-efficacy in communicating with children and their families about achieving a healthy body weight, and therefore would likely benefit from the input from children and the patient-centred theme of MI.
It is based on the Trans-Theoretical Model and Stages of Change which postulates that people follow a step-wise progression towards change with specific constructs that need to be addressed before moving to the next step.
These constructs are integral to the principles of MI
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in physician practice from baseline
Lasso di tempo: 1 year
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Recording the changes compared to baseline for physician's practice with their overweight patients (ie calculating, plotting, and tracking BMI as well as initiate discussion around obesity)
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1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physician Self Efficacy
Lasso di tempo: Baseline, 6 and 12months after intervention
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Physicians will be asked to complete a self-efficacy questionnaire about their perception of their own abilities to initiate discussion with pediatric patients and/or their families about overweight, tendencies of frequency of BMI calculating, plotting, and tracking, identify obesity or overweight in their pediatric patients, as well as identify the type of barriers they have in preventing/treating obesity.
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Baseline, 6 and 12months after intervention
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1000013526
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 .
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