ObesityNCT01156103
Reducing Pediatric Obesity Through After-school Programs
A study testing America SCORES, Bay Area in people with Obesity, run by University of California, San Francisco.
Trial summary
This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- America SCORES, Bay Area
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Dec 2010
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 3rd-5th grade student enrolled in after-school program in San Francisco Unified School District
Who cannot join
- Uncontrolled asthma
- Unable to participate in moderate physical activity
About this study
This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.
Read the detailed description
Baseline measures were collected in September 2009; midpoint measures were collected in January 2010; and final measures were collected in May 2010. Repeated measures analyses will compare trajectories for BMI, physical activity, and fitness between students in the SCORES and the usual care arms.
- Conditions
- Obesity
- Being tested
- America SCORES, Bay Area
- Keywords
- obesity, minority, child, physical fitness, school, 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.
America SCORES, Bay AreaBehavioural
After-school program promoting physical activity via soccer 3 days/week
| Study group | Role | What they receive |
|---|---|---|
| SCORES | Experimental | America SCORES, Bay Area, after-school program Receives: Behavioral: America SCORES, Bay Area |
| Usual care | No intervention | Standard after-school programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI z-score
Measured: Baseline (0 months) and 9 months
Secondary outcomes (1)
Change in Aerobic capacity
Measured: Baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionDec 2010
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Unified School District, America SCORES, Bay Area, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kristine A Madsen, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156103
- Sponsor's protocol ID
- H48814-32411-0
- Other IDs
- 1K23HD054470-01A1
- Status last verified
- May 2015
- First submitted
- 17 Feb 2009
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Madsen K, Thompson H, Adkins A, Crawford Y. School-community partnerships: a cluster-randomized trial of an after-school soccer program. JAMA Pediatr. 2013 Apr;167(4):321-6. doi: 10.1001/jamapediatrics.2013.1071.
PubMed 23440308
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Pediatric Obesity Through After-school Programs
- ClinicalTrials.gov ID
- NCT01156103
- Acronym / sponsor ID
- H48814-32411-0
- Conditions
- Obesity
- Keywords
- obesity, minority, child, physical fitness, school, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Unified School District, America SCORES, Bay Area, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Jul 2010 (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.
This study will assess the impact of a national, community-based after-school program promoting physical activity (America SCORES) on obesity, fitness and important cardiovascular risk factors among minority children. The investigators central hypothesis is that established community-based programs, such as America SCORES, can reduce obesity and cardiovascular risk among participants. The 1-year study followed 158 children from 6 public schools, 3 of which were randomized to have SCORES and 3 to "usual care" after-school program. Primary outcomes are change in body mass index (BMI), physical activity (measured by accelerometer), and fitness (aerobic capacity assessed with the 20-meter shuttle test). Cardiovascular outcomes include blood pressure, body composition (assessed using bioelectrical impedance) and waist circumference. The investigators will also measure academic outcomes.
Detailed description
Baseline measures were collected in September 2009; midpoint measures were collected in January 2010; and final measures were collected in May 2010. Repeated measures analyses will compare trajectories for BMI, physical activity, and fitness between students in the SCORES and the usual care arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCORES | Experimental | Behavioral: America SCORES, Bay AreaAmerica SCORES, Bay Area, after-school program |
| Usual care | No intervention | –Standard after-school programming |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 3rd-5th grade student enrolled in after-school program in San Francisco Unified School District
Key exclusion criteria (2 listed)
- Uncontrolled asthma
- Unable to participate in moderate physical activity
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 |
|---|---|---|
| America SCORES, Bay AreaAfter-school program promoting physical activity via soccer 3 days/week | Behavioural | SCORES |
Primary outcome
Change in BMI z-score
Time frame: Baseline (0 months) and 9 months
1 secondary outcome
Change in Aerobic capacity
Time frame: Baseline and 9 months
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 8 May 2015.
- Derived from this study: PubMed 23440308Madsen K, Thompson H, Adkins A, Crawford Y. School-community partnerships: a cluster-randomized trial of an after-school soccer program. JAMA Pediatr. 2013 Apr;167(4):321-6. doi: 10.1001/jamapediatrics.2013.1071.
Related trials for Obesity
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
RecruitingPhase 3
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mildly Reduced Ejection Fraction
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
Evaluation of the Axomove Therapy Medical Device to Facilitate Adapted Physical Activity for Patients With Obesity
Obese Adults
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Kristine A Madsen, MD, MPH principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing America SCORES, Bay Area in people with Obesity, run by University of California, San Francisco.
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 1 inclusion and 2 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 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in BMI z-score (time frame: Baseline (0 months) and 9 months). 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 NCT01156103, 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 8 May 2015.