NCT01382121

Brief Summary

The purpose of this study is to implement a peer modeling intervention to improve self-efficacy and aerobic fitness in obese youth. A total of 40 obese (defined as Body Mass Index greater than the 95th percentile for age and gender) youth will participate in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for early_phase_1 diabetes

Timeline
Completed

Started Sep 2010

Typical duration for early_phase_1 diabetes

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.6 years

First QC Date

April 21, 2011

Last Update Submit

June 25, 2012

Conditions

Diabetes

Keywords

Peer modelingObservational learningObesityAdolescentsMaximum ventilatory oxygenAerobic fitnessHealth behaviour

Outcome Measures

Primary Outcomes (2)

  • Physiological measure: Aerobic Fitness

    Changes in aerobic fitness from baseline (day 1) to follow-up (day 7) will be evaluated by a trained exercise physiologist using a standardized, maximal incremental exercise protocol (Modified Bruce protocol) on a treadmill. Expired gases will be analyzed using a metabolic cart (Cosmed Quark B2 cardiopulmonary testing, Image Monitoring). Peak oxygen consumption (Peak VO2) will be determined by taking the highest values during a 15 second period and expressed in absolute (l/min) and relative (ml/kg/min) units with the latter unit used for subsequent analysis.

    Baseline (day 1) and follow-up (day 7)

  • Psychological: Self-Efficacy

    Changes in self-efficacy from baseline (day 1) to follow-up (day 7) will be evaluated by an 18-item Self-Efficacy Scale (adapted from McAuley \& Milhalko, 1998) to evaluate participants' confidence to successfully perform increasing intensities and durations of physical activity.

    Baseline (day 1) and follow-up (day 7)

Secondary Outcomes (1)

  • Changes in variability (standard deviation)

    Baseline (day 1) and follow-up (day 7)

Study Arms (2)

Peer modeling

EXPERIMENTAL

Participants watch a video geared to increase confidence in ability to preform fitness test. Male participants will watch a video of a male adolescent completing the fitness test and talking about coping mechanisms used to preform to the best of his ability. Female participants will watch a video of a female adolescent completing the fitness test and talking about coping mechanisms used to preform to the best of her ability.

Behavioral: Peer Modeling

Control

ACTIVE COMPARATOR

Participants watch a video unrelated to the fitness test and self-efficacy. The video depicts healthy food and nutrition options.

Behavioral: Control

Interventions

Peer ModelingBEHAVIORAL

Participants watch a video of an adolescent completing the fitness test and explaining coping mechanisms to preform the test well.

Also known as: Observational Learning, Coping Model
Peer modeling
ControlBEHAVIORAL

watching a video unrelated to the fitness test and self-efficacy

Also known as: Contact control, Active control
Control

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents aged 10-17 years who are obese, defined as Body Mass Index greater than the 95th percentile for age and gender

You may not qualify if:

  • Participants who smoke, are pregnant or have an illness or disease will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise and Health Psychology Laboratory

London, Ontario, N6A 5B9, Canada

Location

Related Publications (7)

  • Willms JD, Tremblay MS, Katzmarzyk PT. Geographic and demographic variation in the prevalence of overweight Canadian children. Obes Res. 2003 May;11(5):668-73. doi: 10.1038/oby.2003.95.

    PMID: 12740457BACKGROUND

  • Cairney J, Hay JA, Faught BE, Leger L, Mathers B. Generalized self-efficacy and performance on the 20-metre shuttle run in children. Am J Hum Biol. 2008 Mar-Apr;20(2):132-8. doi: 10.1002/ajhb.20690.

    PMID: 17990324BACKGROUND

  • Carrel AL, Sledge JS, Ventura SJ, Clark RR, Peterson SE, Eickhoff J, Allen DB. Measuring aerobic cycling power as an assessment of childhood fitness. J Strength Cond Res. 2007 Aug;21(3):685-8. doi: 10.1519/R-22606.1.

    PMID: 17685725BACKGROUND

  • Korsten-Reck U, Kaspar T, Korsten K, Kromeyer-Hauschild K, Bos K, Berg A, Dickhuth HH. Motor abilities and aerobic fitness of obese children. Int J Sports Med. 2007 Sep;28(9):762-7. doi: 10.1055/s-2007-964968. Epub 2007 May 11.

    PMID: 17497579BACKGROUND

  • Jones RA, Okely AD, Caputi P, Cliff DP. Perceived and actual competence among overweight and non-overweight children. J Sci Med Sport. 2010 Nov;13(6):589-96. doi: 10.1016/j.jsams.2010.04.002. Epub 2010 Jul 2.

    PMID: 20580314BACKGROUND

  • Greenhalgh J, Dowey AJ, Horne PJ, Fergus Lowe C, Griffiths JH, Whitaker CJ. Positive- and negative peer modelling effects on young children's consumption of novel blue foods. Appetite. 2009 Jun;52(3):646-653. doi: 10.1016/j.appet.2009.02.016. Epub 2009 Mar 6.

    PMID: 19501762BACKGROUND

  • Horne PJ, Hardman CA, Lowe CF, Rowlands AV. Increasing children's physical activity: a peer modelling, rewards and pedometer-based intervention. Eur J Clin Nutr. 2009 Feb;63(2):191-8. doi: 10.1038/sj.ejcn.1602915. Epub 2007 Sep 19.

    PMID: 17882131BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusObesity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Harry Prapavessis, PhD

    The University of Western Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2011

First Posted

June 27, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

CA(1)