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

Obesity Clinical Trial

— ACT  

Official title:

Self-Determination for Increasing Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028144
• Other study ID #: Pro00005526
• Secondary ID: R01HD045693
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2004
• Est. completion date: May 2009

Study information

• Verified date: December 2009
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1422
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Obesity
• Physical Activity

Intervention

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.
• General Health Program
A 17-week general health afterschool intervention (comparison program) focused on nutrition, stress management, drug prevention, and drop-out prevention.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wilson DK, Kitzman-Ulrich H, Williams JE, Saunders R, Griffin S, Pate R, Van Horn ML, Evans A, Hutto B, Addy CL, Mixon G, Sisson SB. An overview of "The Active by Choice Today" (ACT) trial for increasing physical activity. Contemp Clin Trials. 2008 Jan;29(1):21-31. doi: 10.1016/j.cct.2007.07.001. Epub 2007 Jul 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	moderate to vigorous physical activity (based on accelerometry estimates)		2 weeks post intervention
Secondary	moderate to vigorous physical activity during the intervention (based on accelerometry estimates)		week 8 of the intervention