Test of an Intervention to Increase Physical Activity Among School Children

NCT ID: NCT01876602

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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This project addresses the current epidemic in obesity and physical inactivity among adolescents in the United States. The goal of the research is to develop effective ways of encouraging adolescents to become and remain physically active. In particular, this project is concerned with identifying adolescents who are reluctant to exercise because they have a high sensitivity to unpleasant feelings while exercising at higher intensities. Once identified, these adolescents can be targeted with an intervention that is designed to teach them to exercise at an intensity level that will generate pleasant feelings and therefore make it more likely that they will seek out opportunities to be physically active. 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.

This study is relevant to the prevention of type 2 diabetes in that it addresses the mechanisms of physical activity behavior change among adolescents. This developmental period is typically characterized by declining participation in physical activity, and thus represents a critical period for intervention. The results will increase understanding about why some adolescents remain active while others do not and will test a novel intervention that may be more effective among reluctant exercisers.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Exercise prescription

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".

Group Type EXPERIMENTAL

feeling states exercise intervention

Intervention Type BEHAVIORAL

exercise prescription based on intensity of exercise that feels good.

traditional exercise

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

Group Type ACTIVE_COMPARATOR

feeling states exercise intervention

Intervention Type BEHAVIORAL

exercise prescription based on intensity of exercise that feels good.

Interventions

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feeling states exercise intervention

exercise prescription based on intensity of exercise that feels good.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no past head trauma
* not depressed
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Margaret Schneider

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret Schneider, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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University of California at Irvine

Irvine, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27481104 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30104987 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24770461 (View on PubMed)

Other Identifiers

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R01DK088800

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK088800

Identifier Type: -

Identifier Source: org_study_id

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