ObesityNCT00722345
Exercise Consultation in Obese Youth
A study testing review of "Canada's Physical Activity Guide for Youth" and Exercise consultation in people with Obesity, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (PA) among adults. It is unknown whether this approach would be efficacious with youth. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- review of "Canada's Physical Activity Guide for Youth" and Exercise consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2005to Aug 2006
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents
- BMI greater than or equal to the 95th percentile for age (2000 CDC growth charts)
Who cannot join
- Pregnancy
- Underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec, H3T 1C5
About this study
Official title: Can Exercise Consultation Increase Activity Levels and Improve Metabolic Markers in Obese Adolescents? A Pilot Study.
Exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (PA) among adults. It is unknown whether this approach would be efficacious with youth. The purpose of this pilot study was to assess whether exercise consultation would increase PA levels and improve anthropometric measures and metabolic markers in obese adolescents.
- Conditions
- Obesity
- Being tested
- review of "Canada's Physical Activity Guide for Youth", Exercise consultation
- Keywords
- Obesity, Physical activity, Adolescents, Exercise counseling intervention
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
review of "Canada's Physical Activity Guide for Youth"Behavioural
The contents of the exercise booklet was reviewed with each participant of the control group by the research fellow. Health Canada's "Canada's Physical Activity Guide for Youth" was used for the exercise booklet
Exercise consultationBehavioural
The exercise consultation consisted of a one-to-one discussion designed to educate the participant, strengthen his/her motivation and develop realistic goals and strategies to promote physical activity based on the patient's stage of change. The consultation was based upon the standardized protocol previously published by Loughlan and Mutrie. The Consultation Guidelines describe the 5 steps involved in an exercise consultation, including: 1) discussing current \& past activities; 2) reviewing the pros \& cons of exercising; 3) discussing the barriers to exercising and strategies for overcoming them; 4) determining the social support available to the patient; and finally, 5) setting realistic, attainable short term and long term goals to enhance physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Behavioral: review of "Canada's Physical Activity Guide for Youth" |
| 2 | Experimental | Not described Receives: Behavioral: Exercise consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity counts per minute (accelerometer data)
Measured: At baseline and at 3 months
Secondary outcomes (6)
Stage of change
Measured: At baseline and at 3 months
Lipids
Measured: At baseline and at 3 months
Glucose
Measured: At baseline and at 3 months
Insulin
Measured: At baseline and at 3 months
Blood pressure
Measured: At baseline and at 3 months
Anthropometric mesures (height, weight, waist circumference, hip circumference)
Measured: At baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startJun 2005
- Primary completionAug 2006
- Study completionAug 2006
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.
- 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
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Melanie Henderson, MD MSc FRCP, Principal investigator, Ste-Justine Hospital/McGill UniversityCeline Huot, MD MSc, Principal investigator, Ste-Justine Hospital/University of MontrealDenis Daneman, MB BCh FRCP, Principal investigator, University of TorontoJanet Hux, MD SM, Principal investigator, University of TorontoAnthony Hanley, PhD, Principal investigator, University of TorontoJennifer McGrath, PhD MPH, Principal investigator, Concordia University, MontrealMarie Lambert, MD, Principal investigator, Ste-Justine Hospital/University of MontrealGillian L Booth, MD MSc, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722345
- Sponsor's protocol ID
- 2162
- Status last verified
- Jun 2005
- First submitted
- 23 Jul 2008
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Exercise Consultation Increase Activity Levels and Improve Metabolic Markers in Obese Adolescents? A Pilot Study.
- ClinicalTrials.gov ID
- NCT00722345
- Acronym / sponsor ID
- 2162
- Conditions
- Obesity
- Keywords
- Obesity, Physical activity, Adolescents, Exercise counseling intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 25 Jul 2008 (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.
Exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (PA) among adults. It is unknown whether this approach would be efficacious with youth. The purpose of this pilot study was to assess whether exercise consultation would increase PA levels and improve anthropometric measures and metabolic markers in obese adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Behavioral: review of "Canada's Physical Activity Guide for Youth" |
| 2 | Experimental | Behavioral: Exercise consultation |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Adolescents
- BMI greater than or equal to the 95th percentile for age (2000 CDC growth charts)
Key exclusion criteria (2 listed)
- Pregnancy
- Underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity
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 |
|---|---|---|
| review of "Canada's Physical Activity Guide for Youth"The contents of the exercise booklet was reviewed with each participant of the control group by the research fellow. Health Canada's "Canada's Physical Activity Guide for Youth" was used for the exercise booklet | Behavioural | 1 |
| Exercise consultationThe exercise consultation consisted of a one-to-one discussion designed to educate the participant, strengthen his/her motivation and develop realistic goals and strategies to promote physical activity based on the patient's stage of change. The consultation was based upon the standardized protocol previously published by Loughlan and Mutrie. The Consultation Guidelines describe the 5 steps involved in an exercise consultation, including: 1) discussing current \& past activities; 2) reviewing the pros \& cons of exercising; 3) discussing the barriers to exercising and strategies for overcoming them; 4) determining the social support available to the patient; and finally, 5) setting realistic, attainable short term and long term goals to enhance physical activity. | Behavioural | 2 |
Primary outcome
Physical activity counts per minute (accelerometer data)
Time frame: At baseline and at 3 months
6 secondary outcomes
Stage of change
Time frame: At baseline and at 3 months
Lipids
Time frame: At baseline and at 3 months
Glucose
Time frame: At baseline and at 3 months
Insulin
Time frame: At baseline and at 3 months
Blood pressure
Time frame: At baseline and at 3 months
Anthropometric mesures (height, weight, waist circumference, hip circumference)
Time frame: At baseline and at 3 months
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 25 Jul 2008.
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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.
Melanie Henderson, MD MSc FRCP principal investigator
Ste-Justine Hospital/McGill University
Celine Huot, MD MSc principal investigator
Ste-Justine Hospital/University of Montreal
Denis Daneman, MB BCh FRCP principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing review of "Canada's Physical Activity Guide for Youth" and Exercise consultation in people with Obesity, run by St. Justine's Hospital 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 2 inclusion and 2 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 25 Jul 2008. 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. Some participants in this study may receive a placebo. 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?
Physical activity counts per minute (accelerometer data) (time frame: At baseline and at 3 months). 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 25 Jul 2008.