- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028144
The Active by Choice Today (ACT) Trial to Increase Physical Activity (ACT)
January 17, 2023 updated by: Dawn Wilson, University of South Carolina
Self-Determination for Increasing Physical Activity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1422
Phase
- Phase 2
- Phase 1
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
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- University of South Carolina
-
-
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 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACT Program
Motivational and Behavioral Skills Physical activity after-school 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 Names:
|
|
Active Comparator: General Health
General health education after-school program
|
A 17-week general health afterschool intervention (comparison program) focused on nutrition, stress management, drug prevention, and drop-out prevention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
moderate to vigorous physical activity (based on accelerometry estimates)
Time Frame: 2 weeks post intervention
|
2 weeks post intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
moderate to vigorous physical activity during the intervention (based on accelerometry estimates)
Time Frame: week 8 of the intervention
|
week 8 of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dawn K Wilson, PhD, University of South Carolina
- Study Director: Heather E Kitzman-Ulrich, PhD, University of South Carolina
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.
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
July 1, 2004
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
December 1, 2009
First Submitted That Met QC Criteria
December 8, 2009
First Posted (Estimate)
December 9, 2009
Study Record Updates
Last Update Posted (Actual)
January 19, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
December 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- Pro00005526
- R01HD045693 (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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