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The Active by Choice Today (ACT) Trial to Increase Physical Activity (ACT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028144
First Posted: December 9, 2009
Last Update Posted: December 10, 2009
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:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
University of South Carolina
  Purpose
The increasing prevalence of obesity in U.S. children and adolescents is a major health threat to our society, especially among minority and low social economic status (SES) populations. During adolescence physical activity (PA) decreases and is likely an important contributor to the increasing trend in childhood obesity rates. Little evidence suggests that school-based curriculum interventions lead to increases in overall PA. Thus, this proposal will evaluate the efficacy of an innovative motivational and behavioral skills after-school program for promoting increases PA among underserved adolescents (e.g., minorities, low SES). The motivational plus behavioral skills intervention is consistent with Self-Determination (Motivation) Theory and Social Cognitive Theory in that it emphasizes increasing intrinsic motivation and behavioral skills for PA. Adolescents in the intervention take part in developing the program, selecting physical activities that generate fun and interest, and generating their own coping strategies for making effective PA changes during a videotaped session. Preliminary data from our group demonstrates the feasibility of the motivational plus behavioral skills PA program for increasing moderate-to-vigorous PA (MVPA) in underserved adolescents in South Carolina. The proposed project will use a school-based nested cohort design to evaluate efficacy of a 17-week motivational plus behavioral skills program versus typical after-school program (general health education only) on increasing PA in underserved adolescents. Twenty-four middle schools (70 6th graders per school; N=1,680), located in South Carolina will be randomly assigned to one of two after-school programs. The study employs a nested cohort design, with schools, rather than individuals assigned to condition and will be analyzed using repeated measures analysis of covariance techniques as outlined by Murray. We will also examine psychosocial variables (PA self-efficacy, self-concept, motivation, social support, and enjoyment) as potential mediators of the intervention on changes in MVPA using regression and structural equation modeling techniques. This study will address an important public health problem that will have implications for decreasing obesity in underserved adolescents.

Condition Intervention Phase
Exercise Physical Activity Obesity Behavioral: Physical Activity Program Behavioral: General Health Program Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Self-Determination for Increasing Physical Activity

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • moderate to vigorous physical activity (based on accelerometry estimates) [ Time Frame: 2 weeks post intervention ]

Secondary Outcome Measures:
  • moderate to vigorous physical activity during the intervention (based on accelerometry estimates) [ Time Frame: week 8 of the intervention ]

Enrollment: 1422
Study Start Date: July 2004
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACT Program
Motivational and Behavioral Skills Physical activity after-school program
Behavioral: Physical Activity Program
A 17-week motivational and behavioral skills after-school intervention for increasing moderate to vigorous physical activity in low income and minority adolescents.
Other Name: ACT
Active Comparator: General Health
General health education after-school program
Behavioral: General Health Program
A 17-week general health afterschool intervention (comparison program) focused on nutrition, stress management, drug prevention, and drop-out prevention.
Other Name: Comparison

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • parental consent
  • agree to random assignment
  • 6th grade student

Exclusion Criteria:

  • medical condition that interfered with physical activity
  • developmentally delayed such that the intervention materials were not cognitively appropriate
  • currently in treatment for a psychiatric disorder
  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): NCT01028144


Locations
United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Dawn K Wilson, PhD University of South Carolina
Study Director: Heather E Kitzman-Ulrich, PhD University of South Carolina
  More Information

Publications:
Responsible Party: Dawn K. Wilson, Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT01028144     History of Changes
Other Study ID Numbers: Project ACT
R01HD045693 ( U.S. NIH Grant/Contract )
First Submitted: December 1, 2009
First Posted: December 9, 2009
Last Update Posted: December 10, 2009
Last Verified: December 2009

Keywords provided by University of South Carolina:
Exercise
Physical Activity
Adolescent
Minority Health