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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01930760
Other study ID # 1000013526
Secondary ID
Status Completed
Phase N/A
First received August 25, 2013
Last updated August 25, 2013
Start date January 2010
Est. completion date June 2013

Study information

Verified date August 2013
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

The proposed study is a randomized control trial evaluating the efficacy of two training programs in increasing physician identification, documentation, and motivation of overweight children. Pediatric primary care physicians will be recruited from the College of Physician and Surgeons of Ontario and randomized into two practice-based interventions (behavioural/educational) which are a one-time training attendance. The educational intervention will focus on the medical management of pediatric obesity, the use of Body Mass Index charts, and information about how obese children would like to be approached by their physicians. The behavioural intervention will incorporate Motivational Interviewing tools in addition to an abbreviated training program received by the educational intervention group.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

1. Toronto area pediatricians and family physicians who are members of the College of Physicians and Surgeons of Ontario

2. Available to attend workshop at the Hospital for Sick Children

3. Pediatric patient population of at least 25% (office audit to be completed by office staff) (to ensure sufficient contact with children and their families

4. 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard Medical Training Educational
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.
Motivational Interviewing behavioural
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

Locations

Country Name City State
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in physician practice from baseline 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) 1 year No
Secondary Physician Self Efficacy 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. Baseline, 6 and 12months after intervention No
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