ObesityNCT00067847
Evaluation of California's SB 19 Pupil Nutrition Act
A study testing State-directed nutrition policy change in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- State-directed nutrition policy change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,020 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to May 2004
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
healthy 4th, 5th or 7th graders able to fill out a 30-minute questionnaire in English and able to participate in aerobic physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
WestEd-Los Alamitos & UCLA Division of Cancer Prevention and Control Research
Los Angeles, California
About this study
Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The impact of early implementation of SB 19 on academic achievement will also be assessed.
Read the detailed description
Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual.
The nutrition provisions in SB19 include assuring that NO elementary school sells carbonated beverages at any time and that no middle schools sell carbonated beverages until after the end of the lunch hour each day. The nutrition provisions also include some restrictions on the sale of high-fat, high-sugar snack foods as well as encouragement to make fruits and vegetables more available to students. The legislation further encourages school districts to invest more heavily in providing students with opportunities to be physically active. High schools are NOT affected by this legislation.
Over 5000 4th, 5th, and 7th graders from 28 schools will be evaluated at baseline, 4-month and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The principal outcome measure is sex- and age-adjusted BMI percentile as determined from the CDC growthchart percentiles. Other measures include waist circumference, time to complete one mile run/walk, and blood pressure.
The impact of early implementation of SB 19 on academic achievement will also be assessed, using students' standardized math and language arts achievement test scores.
- Conditions
- Obesity
- Being tested
- State-directed nutrition policy change
- Keywords
- obesity, food policy, physical fitness (Respiratory Burst), academic achievement
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-directed nutrition policy changeBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2003 (estimated)
- Study startJul 2003
- Study completionMay 2004
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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,020 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, Los Angeles, University of California, Berkeley, California Department of Education, The California Endowment
- Investigators
- William J McCarthy, Ph.D., Principal investigator, WestEd-Los Alamitos & UCLA Division of Cancer Prevention and Control Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067847
- Sponsor's protocol ID
- ECSB19PNA (completed)
- Status last verified
- Jan 2010
- First submitted
- 28 Aug 2003
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of California's SB 19 Pupil Nutrition Act
- ClinicalTrials.gov ID
- NCT00067847
- Acronym / sponsor ID
- ECSB19PNA (completed)
- Conditions
- Obesity
- Keywords
- obesity, food policy, physical fitness (Respiratory Burst), academic achievement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,020 participants
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Collaborators
- University of California, Los Angeles, University of California, Berkeley, California Department of Education, The California Endowment
- Study start
- Jul 2003
- Study completion
- May 2004
- First posted
- 1 Sep 2003 (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.
Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual. Over 5000 4th, 5th and 7th graders will be evaluated at baseline, 4-month, and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The impact of early implementation of SB 19 on academic achievement will also be assessed.
Detailed description
Four California school districts will be randomized to early implementation of California's SB 19 Pupil Nutrition Act or to business as usual.
The nutrition provisions in SB19 include assuring that NO elementary school sells carbonated beverages at any time and that no middle schools sell carbonated beverages until after the end of the lunch hour each day. The nutrition provisions also include some restrictions on the sale of high-fat, high-sugar snack foods as well as encouragement to make fruits and vegetables more available to students. The legislation further encourages school districts to invest more heavily in providing students with opportunities to be physically active. High schools are NOT affected by this legislation.
Over 5000 4th, 5th, and 7th graders from 28 schools will be evaluated at baseline, 4-month and 16-month follow-up in order to determine if the SB 19 nutrition and physical activity policies have had an impact on students' risk of excess body weight. The principal outcome measure is sex- and age-adjusted BMI percentile as determined from the CDC growthchart percentiles. Other measures include waist circumference, time to complete one mile run/walk, and blood pressure.
The impact of early implementation of SB 19 on academic achievement will also be assessed, using students' standardized math and language arts achievement test scores.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| State-directed nutrition policy change | Behavioural | – |
Primary outcome
Not reported in the source record.
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 13 Jan 2010.
- Dietary Guidelines for Americans (5th ed.)Link provided by the sponsor.
- Legislative language of California's SB 19 Pupil Nutrition ActLink provided by the sponsor.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
William J McCarthy, Ph.D. principal investigator
WestEd-Los Alamitos & UCLA Division of Cancer Prevention and Control Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing State-directed nutrition policy change in people with Obesity, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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?
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 13 Jan 2010. 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.
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 13 Jan 2010.