ExercisePhase 1/2ACTNCT01028144
The Active by Choice Today (ACT) Trial to Increase Physical Activity
A Phase 1/2 study testing Physical Activity Program and General Health Program in people with Exercise and Physical Activity, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Physical Activity, Obesity
- What is being tested?
- Physical Activity Program and General Health Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,422 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to May 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parental consent
- agree to random assignment
- 6th grade student
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
- Conditions
- Exercise, Physical Activity, Obesity
- Being tested
- Physical Activity Program, General Health Program
- Keywords
- Exercise, Physical Activity, Adolescent, Minority Health
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity ProgramBehavioural
Also called ACT
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 ProgramBehavioural
Also called Comparison
A 17-week general health afterschool intervention (comparison program) focused on nutrition, stress management, drug prevention, and drop-out prevention.
| Study group | Role | What they receive |
|---|---|---|
| ACT Program | Experimental | Motivational and Behavioral Skills Physical activity after-school program Receives: Behavioral: Physical Activity Program |
| General Health | Active comparator | General health education after-school program Receives: Behavioral: General Health Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
moderate to vigorous physical activity (based on accelerometry estimates)
Measured: 2 weeks post intervention
Secondary outcomes (1)
moderate to vigorous physical activity during the intervention (based on accelerometry estimates)
Measured: week 8 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startJul 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dawn Wilson, University of South Carolina
- Investigators
- Dawn K Wilson, PhD, Principal investigator, University of South CarolinaHeather E Kitzman-Ulrich, PhD, Study director, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028144
- Sponsor's protocol ID
- Pro00005526
- Other IDs
- R01HD045693
- Acronym
- ACT
- Status last verified
- Dec 2009
- First submitted
- 1 Dec 2009
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17716952
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Determination for Increasing Physical Activity
- ClinicalTrials.gov ID
- NCT01028144
- Acronym / sponsor ID
- ACT / Pro00005526
- Conditions
- Exercise, Physical Activity, Obesity
- Keywords
- Exercise, Physical Activity, Adolescent, Minority Health
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,422 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT Program | Experimental | Behavioral: Physical Activity ProgramMotivational and Behavioral Skills Physical activity after-school program |
| General Health | Active comparator | Behavioral: General Health ProgramGeneral health education after-school program |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parental consent
- agree to random assignment
- 6th grade student
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity ProgramAlso: ACTA 17-week motivational and behavioral skills after-school intervention for increasing moderate to vigorous physical activity in low income and minority adolescents. | Behavioural | ACT Program |
| General Health ProgramAlso: ComparisonA 17-week general health afterschool intervention (comparison program) focused on nutrition, stress management, drug prevention, and drop-out prevention. | Behavioural | General Health |
Primary outcome
moderate to vigorous physical activity (based on accelerometry estimates)
Time frame: 2 weeks post intervention
1 secondary outcome
moderate to vigorous physical activity during the intervention (based on accelerometry estimates)
Time frame: week 8 of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Background: PubMed 17716952Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn K Wilson, PhD principal investigator
University of South Carolina
Heather E Kitzman-Ulrich, PhD study director
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Physical Activity Program and General Health Program in people with Exercise and Physical Activity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
moderate to vigorous physical activity (based on accelerometry estimates) (time frame: 2 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01028144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.