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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT00318877
Study groupRoleWhat they receive
After school sportsExperimentalAfter school team sports
Receives: Behavioral: After school team sports program
Health and Nutrition EducationActive comparatorHealth 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.

  1. Body mass index (BMI)

    Measured: baseline to follow-up

Secondary outcomes (7)
  1. Waist circumference

    Measured: baseline to follow-up

  2. Triceps skinfold thickness

    Measured: baseline to follow-up

  3. Resting heart rate

    Measured: baseline to follow-up

  4. Blood pressure

    Measured: baseline to follow-up

  5. Physical activity monitoring

    Measured: baseline to follow-up

  6. Sedentary behaviors

    Measured: baseline to follow-up

  7. 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.

  1. First posted27 Apr 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

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)
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

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.

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