ObesitySPEAK IM OKNCT01930760
Supporting Physicians With Education And Know-how in Identifying and Motivating Overweight Kids
A study testing Standard Medical Training Educational and Motivational Interviewing behavioural in people with Obesity, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Standard Medical Training Educational and Motivational Interviewing behavioural
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supporting Physicians With Education And Know-how in Identifying and Motivating Overweight Kids: SPEAK IM OK
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.
Read the detailed 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
- Conditions
- Obesity
- Being tested
- Standard Medical Training Educational, Motivational Interviewing behavioural
- Keywords
- pediatric, Childhood Obesity, motivational interviewing, pediatric primary care physicians
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Medical Training EducationalBehavioural
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 behaviouralBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Educational Intervention Group | Experimental | Not described Receives: Behavioral: Standard Medical Training Educational |
| Behavioural Intervention Group | Experimental | Not described Receives: Behavioral: Motivational Interviewing behavioural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (1)
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.
Measured: Baseline, 6 and 12months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian McCrindle, The Hospital for Sick Children
- Investigators
- Brian W McCrindle, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930760
- Sponsor's protocol ID
- 1000013526
- Acronym
- SPEAK IM OK
- Status last verified
- Aug 2013
- First submitted
- 25 Aug 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Physicians With Education And Know-how in Identifying and Motivating Overweight Kids: SPEAK IM OK
- ClinicalTrials.gov ID
- NCT01930760
- Acronym / sponsor ID
- SPEAK IM OK / 1000013526
- Conditions
- Obesity
- Keywords
- pediatric, Childhood Obesity, motivational interviewing, pediatric primary care physicians
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention Group | Experimental | Behavioral: Standard Medical Training Educational |
| Behavioural Intervention Group | Experimental | Behavioral: Motivational Interviewing behavioural |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Medical Training EducationalEducational 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. | Behavioural | Educational Intervention Group |
| Motivational Interviewing behaviouralThe 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 | Behavioural Intervention Group |
Primary outcome
Change in physician practice from baseline
Time frame: 1 year
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 secondary outcome
Physician Self Efficacy
Time frame: Baseline, 6 and 12months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian W McCrindle, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Medical Training Educational and Motivational Interviewing behavioural in people with Obesity, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physician practice from baseline (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2013.