NCT01876602

Brief Summary

The specific aims of this study are to: 1) evaluate the impact of a novel intervention delivered via school-based physical education (PE) on adolescents who have a high sensitivity to exercise-induced negative affect; 2) determine whether adolescents' tendency to feel uncomfortable during exercise is a stable trait that persists even in the face of an intervention; and 3) compare and contrast three alternative methods of measuring adolescents' sensitivity to exercise-induced affect. Healthy middle-school students who do not participate in team or individual competitive sports will be recruited and assessed to determine their existing predisposition toward exercise (i.e., "reluctant exercisers" and "latent exercisers"). The assessment will be conducted using three methods that have been used to measure individuals' propensity to experience positive affect in the face of a stimulus: 1) a pencil-and-paper assessment that measures tendency to respond to a challenge with positive affect; 2) electroencephalogram (EEG) to ascertain frontal cortical asymmetry; and 3) empirically assessed affective response to a standardized exercise task. Reluctant and latent exercisers will be assigned in equal numbers to one of two conditions. One condition will implement a PE-based intervention that differs from the traditional approach in that students will be instructed to exercise at an intensity that has been determined to elicit positive affect in that individual (based on baseline testing). In the other condition, students will be instructed to exercise at an intensity derived from standard formulas typically used in exercise prescriptions. It is hypothesized that the non-traditional approach will increase reluctant exercisers' enjoyment of PE and also their level of participation in physical activity outside of PE. The latter will be determined using portable monitors (accelerometers) worn at baseline, after the intervention, and again 1 year after the end of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2011

Longer than P75 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

April 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

5.9 years

First QC Date

June 10, 2013

Last Update Submit

May 14, 2018

Conditions

Keywords

adolescentsexercisefitnessschool-based

Outcome Measures

Primary Outcomes (1)

  • Physical Activity

    Participation in physical activity is assessing objectively (using activity monitors), by self-report, and indirectly via cardiorespiratory fitness.

    1 year

Secondary Outcomes (1)

  • affective response to exercise

    1 year

Study Arms (2)

Exercise prescription

EXPERIMENTAL

Participants are given an exercise prescription in the form of a target heart rate range for exercising. The range is determined based on their personal preferences so that it is an intensity that feels "good".

Behavioral: feeling states exercise intervention

traditional exercise

ACTIVE COMPARATOR

participants are given an exercise prescription based on percent of vo2 peak

Behavioral: feeling states exercise intervention

Interventions

exercise prescription based on intensity of exercise that feels good.

Exercise prescriptiontraditional exercise

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy
  • not a member of a sports team
  • right handed

You may not qualify if:

  • no past head trauma
  • not depressed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Irvine

Irvine, California, 92697, United States

Location

Related Publications (3)

  • Schneider M, Schmalbach P, Godkin S. Impact of a personalized versus moderate-intensity exercise prescription: a randomized controlled trial. J Behav Med. 2017 Apr;40(2):239-248. doi: 10.1007/s10865-016-9776-0. Epub 2016 Aug 1.

    PMID: 27481104BACKGROUND
  • Schneider M. Intrinsic Motivation Mediates the Association Between Exercise-Associated Affect and Physical Activity Among Adolescents. Front Psychol. 2018 Jul 30;9:1151. doi: 10.3389/fpsyg.2018.01151. eCollection 2018.

  • Schneider M, Schmalbach P. Affective Response to Exercise and Preferred Exercise Intensity Among Adolescents. J Phys Act Health. 2015 Apr;12(4):546-52. doi: 10.1123/jpah.2013-0442. Epub 2014 Apr 17.

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Margaret Schneider, PhD

    University of California, Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

April 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations