Test of an Intervention to Increase Physical Activity Among School Children

May 14, 2018 updated by: Margaret Schneider, University of California, Irvine

Feeling States and Heart Rates; A Translational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California at Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no past head trauma
  • not depressed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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".
Behavioral: feeling states exercise intervention
exercise prescription based on intensity of exercise that feels good.
Active Comparator: traditional exercise
participants are given an exercise prescription based on percent of vo2 peak
Behavioral: feeling states exercise intervention
exercise prescription based on intensity of exercise that feels good.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 1 year
Participation in physical activity is assessing objectively (using activity monitors), by self-report, and indirectly via cardiorespiratory fitness.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
affective response to exercise
Time Frame: 1 year
Affective response to exercise is assessed by measuring how participants feel during a standardized exercise task and by self-report of enjoyment of activity.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

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

Investigators

  • Principal Investigator: Margaret Schneider, PhD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DK088800
  • R01DK088800 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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