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

NCT01028144 | Completed Phase 1 DMC

• 2 other identifiers: Pro00005526R01HD045693
• Study Type: interventional
• Target: 1,422
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Exercise; Physical Activity; Obesity

Keywords

Exercise; Physical Activity; Adolescent; Minority Health

Outcome Measures

Primary Outcomes (1)

• moderate to vigorous physical activity (based on accelerometry estimates)

  2 weeks post intervention

Secondary Outcomes (1)

• moderate to vigorous physical activity during the intervention (based on accelerometry estimates)

  week 8 of the intervention

Study Arms (2)

ACT Program

EXPERIMENTAL

Motivational and Behavioral Skills Physical activity after-school program

Behavioral: Physical Activity Program

General Health

ACTIVE COMPARATOR

General health education after-school program

Behavioral: General Health Program

Interventions

Physical Activity Program BEHAVIORAL

A 17-week motivational and behavioral skills after-school intervention for increasing moderate to vigorous physical activity in low income and minority adolescents.

Also known as: ACT

ACT Program

General Health Program BEHAVIORAL

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

Also known as: Comparison

General Health

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related 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.

  PMID: 17716952 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Obesity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dawn K Wilson, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

• Heather E Kitzman-Ulrich, PhD

  University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 9, 2009
• Study Start: July 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 19, 2023

Record last verified: 2009-12

Locations

US (1)