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Test of an Intervention to Increase Physical Activity Among School Children

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01876602
First Posted: June 12, 2013
Last Update Posted: December 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Margaret Schneider, University of California, Irvine
  Purpose

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.


Condition Intervention
Obesity Behavioral: feeling states exercise intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Feeling States and Heart Rates; A Translational Study

Resource links provided by NLM:


Further study details as provided by Margaret Schneider, University of California, Irvine:

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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 140
Study Start Date: April 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no past head trauma
  • not depressed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876602


Locations
United States, California
University of California at Irvine
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Margaret Schneider, PhD University of California, Irvine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margaret Schneider, Principal Investigator, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01876602     History of Changes
Other Study ID Numbers: DK088800
R01DK088800 ( U.S. NIH Grant/Contract )
First Submitted: June 10, 2013
First Posted: June 12, 2013
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Margaret Schneider, University of California, Irvine:
adolescents
exercise
fitness
school-based