NCT01930760

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

August 25, 2013

Last Update Submit

August 25, 2013

Conditions

Keywords

pediatricChildhood Obesitymotivational interviewingpediatric primary care physicians

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Physician Self Efficacy

    Baseline, 6 and 12months after intervention

Study Arms (2)

Educational Intervention Group

EXPERIMENTAL
Behavioral: Standard Medical Training Educational

Behavioural Intervention Group

EXPERIMENTAL
Behavioral: Motivational Interviewing behavioural

Interventions

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.

Educational Intervention Group

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

Behavioural Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

MeSH Terms

Conditions

ObesityPediatric Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian W McCrindle, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Cardiologist

Study Record Dates

First Submitted

August 25, 2013

First Posted

August 29, 2013

Study Start

January 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations