ObesityNCT00318877
Sports to Prevent Obesity
A study testing After school team sports program and After school health education program in people with Obesity, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to learn whether overweight children who participate in an after school team sports program improve their health as much as overweight children in a more traditional health education program. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- After school team sports program and After school health education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jul 2008
- Phase
- Interventional
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- In the participating school district
- 8-11.9 years old
- BMI >= 85th percentile for age and sex on the 2000 Centers for Disease Control (CDC) growth charts
- Clearance to participate from medical care provider
- Willing, able, and available to attend an after school program
- Not planning to move from school district within the next 12 months
Show all 9Show fewer
- Speaks and reads English or Spanish
- Child has not repeated more than one grade in school
- Completion of signed active informed consent (parent or guardian) and assent (child) to participate, which includes a description of the two interventions and requires their willingness to be randomized.
Who cannot join
- The investigators' goal is to be as inclusive as possible, however, children will not be eligible to participate if they:
- Have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease)
- Have been diagnosed with a chronic illness that affects their growth and/or weight (e.g. type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- Have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- Are taking other medications affecting their growth and/or weight [e.g. methylphenidate hydrochloride (HCL)]
- Are pregnant
- Are unable to complete the informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Palo Alto, California, 94305
About this study
Official title: Sports to Prevent Obesity Randomized Trial
The purpose of this study is to learn whether overweight children who participate in an after school team sports program improve their health as much as overweight children in a more traditional health education program.
Read the detailed description
There is an urgent need for feasible, effective, and cost-efficient programs to help overweight children control their weight. To start to address this unmet need, we are evaluating after school team sports as an intervention for reducing weight gain among low-income and at-risk of being overweight, and overweight children. After school sports programs may be generalizable, motivating, and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income, at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included.
We propose a 1 year randomized controlled trial comparing weight changes among low-income, overweight children randomized to participate in an after school team sports program versus a traditional weight control/health education program.
- Conditions
- Obesity
- Being tested
- After school team sports program, After school health education program
- Keywords
- Obesity, Physical activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After school team sports programBehavioural
After school health education programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| After school sports | Experimental | After school team sports Receives: Behavioral: After school team sports program |
| Health and Nutrition Education | Active comparator | Health and Nutrition Education Active Placebo Control Receives: Behavioral: After school health education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
Measured: baseline to follow-up
Secondary outcomes (7)
Waist circumference
Measured: baseline to follow-up
Triceps skinfold thickness
Measured: baseline to follow-up
Resting heart rate
Measured: baseline to follow-up
Blood pressure
Measured: baseline to follow-up
Physical activity monitoring
Measured: baseline to follow-up
Sedentary behaviors
Measured: baseline to follow-up
Psychosocial measures
Measured: baseline to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas N Robinson, MD, MPH, Principal investigator, Stanford UniversityDana L Weintraub, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318877
- Sponsor's protocol ID
- 31487
- Other IDs
- 1R03DK070580-01
- Status last verified
- Dec 2012
- First submitted
- 25 Apr 2006
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sports to Prevent Obesity Randomized Trial
- ClinicalTrials.gov ID
- NCT00318877
- Acronym / sponsor ID
- 31487
- Conditions
- Obesity
- Keywords
- Obesity, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Apr 2006 (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 purpose of this study is to learn whether overweight children who participate in an after school team sports program improve their health as much as overweight children in a more traditional health education program.
Detailed description
There is an urgent need for feasible, effective, and cost-efficient programs to help overweight children control their weight. To start to address this unmet need, we are evaluating after school team sports as an intervention for reducing weight gain among low-income and at-risk of being overweight, and overweight children. After school sports programs may be generalizable, motivating, and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income, at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included.
We propose a 1 year randomized controlled trial comparing weight changes among low-income, overweight children randomized to participate in an after school team sports program versus a traditional weight control/health education program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After school sports | Experimental | Behavioral: After school team sports programAfter school team sports |
| Health and Nutrition Education | Active comparator | Behavioral: After school health education programHealth and Nutrition Education Active Placebo Control |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- In the participating school district
- 8-11.9 years old
- BMI >= 85th percentile for age and sex on the 2000 Centers for Disease Control (CDC) growth charts
- Clearance to participate from medical care provider
- Willing, able, and available to attend an after school program
Key exclusion criteria (7 listed)
- The investigators' goal is to be as inclusive as possible, however, children will not be eligible to participate if they:
- Have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease)
- Have been diagnosed with a chronic illness that affects their growth and/or weight (e.g. type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- Have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- Are taking other medications affecting their growth and/or weight [e.g. methylphenidate hydrochloride (HCL)]
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 |
|---|---|---|
| After school team sports program | Behavioural | After school sports |
| After school health education program | Behavioural | Health and Nutrition Education |
Primary outcome
Body mass index (BMI)
Time frame: baseline to follow-up
7 secondary outcomes
Waist circumference
Time frame: baseline to follow-up
Triceps skinfold thickness
Time frame: baseline to follow-up
Resting heart rate
Time frame: baseline to follow-up
Blood pressure
Time frame: baseline to follow-up
Physical activity monitoring
Time frame: baseline to follow-up
Sedentary behaviors
Time frame: baseline to follow-up
Psychosocial measures
Time frame: baseline to follow-up
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 17 Dec 2012.
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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.
Thomas N Robinson, MD, MPH principal investigator
Stanford University
Dana L Weintraub, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After school team sports program and After school health education program in people with Obesity, run by Stanford University 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 9 inclusion and 7 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 17 Dec 2012. 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.
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?
Body mass index (BMI) (time frame: baseline to follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2012.