NCT00722345

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2005

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

June 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
Last Updated

July 25, 2008

Status Verified

June 1, 2005

Enrollment Period

1.2 years

First QC Date

July 23, 2008

Last Update Submit

July 24, 2008

Conditions

Obesity

Keywords

ObesityPhysical activityAdolescentsExercise counseling intervention

Outcome Measures

Primary Outcomes (1)

  • Physical activity counts per minute (accelerometer data)

    At baseline and at 3 months

Secondary Outcomes (6)

  • Stage of change

    At baseline and at 3 months

  • Lipids

    At baseline and at 3 months

  • Glucose

    At baseline and at 3 months

  • Insulin

    At baseline and at 3 months

  • Blood pressure

    At baseline and at 3 months

  • +1 more secondary outcomes

Study Arms (2)

1

PLACEBO COMPARATOR
Behavioral: review of "Canada's Physical Activity Guide for Youth"

2

EXPERIMENTAL
Behavioral: Exercise consultation

Interventions

review of "Canada's Physical Activity Guide for Youth"BEHAVIORAL

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

1
Exercise consultationBEHAVIORAL

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.

2

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents
  • BMI greater than or equal to the 95th percentile for age (2000 CDC growth charts)

You may not qualify if:

  • Pregnancy
  • Underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Ste-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Melanie Henderson, MD MSc FRCP

    Ste-Justine Hospital/McGill University

    PRINCIPAL INVESTIGATOR

  • Celine Huot, MD MSc

    Ste-Justine Hospital/University of Montreal

    PRINCIPAL INVESTIGATOR

  • Denis Daneman, MB BCh FRCP

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Janet Hux, MD SM

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Anthony Hanley, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Jennifer McGrath, PhD MPH

    Concordia University, Montreal

    PRINCIPAL INVESTIGATOR

  • Marie Lambert, MD

    Ste-Justine Hospital/University of Montreal

    PRINCIPAL INVESTIGATOR

  • Gillian L Booth, MD MSc

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

June 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

July 25, 2008

Record last verified: 2005-06

Locations

CA(1)