Child Physical ActivityOSNAPNCT01396473
Study on Out of School Nutrition and Physical Activity Environments
A study testing Policy and Environmental Change in people with Child Physical Activity and Child Nutrition, run by Harvard School of Public Health (HSPH) at 1 site in United States.
Trial summary
The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Physical Activity, Child Nutrition
- What is being tested?
- Policy and Environmental Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Afterschool programs in Boston MA serving at least 40 children ages 5-12 years operating the full school year between September and June
- Afterschool programs serving a snack to children
- Children between the ages of 5 and 12 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard Prevention Research Center
Boston, Massachusetts, 02215
About this study
The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.
Read the detailed description
Nearly half of Boston's school age children (49%) participate in out of school time programs, a critical time to intervene on physical activity and nutrition. Previous research has mostly focused on during-school-day efforts, or on child care policies and practices for very young children, leaving a gap in the knowledge of what might work with programs serving school-age children during out of school time. OSNAP aims to implement low cost and sustainable policy and environmental interventions to improve physical activity and healthy eating/beverage environments. Data will be collected via observations, plate waste and accelerometers on program policies, environments, practices and behavioral outcomes related to physical activity, beverage, snack and screen time outcomes.
- Conditions
- Child Physical Activity, Child Nutrition
- Being tested
- Policy and Environmental Change
- Keywords
- afterschool, accelerometers, plate waste, policy, environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Policy and Environmental ChangeBehavioural
Afterschool programs participate in an assessment of physical activity and nutrition practices and policies. Study staff work with teams of afterschool programs in a participatory manner to identify areas in which programs would like to take practice, policy and communication efforts to meet physical activity and nutrition goals. Teams share progress and barriers during ongoing collaborative meetings.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| Policy and Environmental Change | Experimental | Not described Receives: Behavioral: Policy and Environmental Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Accelerometer and SOPLAY observation
Measured: Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention
Secondary outcomes (1)
Change in dietary intake
plate waste consumption
Measured: Participants' dietary intake will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Child Physical ActivityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Steven Gortmaker, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396473
- Sponsor's protocol ID
- 18046
- Other IDs
- CDC Grant Number
- Acronym
- OSNAP
- Status last verified
- Jul 2011
- First submitted
- 27 Jan 2011
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Virgara R, Phillips A, Lewis LK, Baldock K, Wolfenden L, Ferguson T, Richardson M, Okely A, Beets M, Maher C. Interventions in outside-school hours childcare settings for promoting physical activity amongst schoolchildren aged 4 to 12 years. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013380. doi: 10.1002/14651858.CD013380.pub2.
PubMed 34694005Lee RM, Giles CM, Cradock AL, Emmons KM, Okechukwu C, Kenney EL, Thayer J, Gortmaker SL. Impact of the Out-of-School Nutrition and Physical Activity (OSNAP) Group Randomized Controlled Trial on Children's Food, Beverage, and Calorie Consumption among Snacks Served. J Acad Nutr Diet. 2018 Aug;118(8):1425-1437. doi: 10.1016/j.jand.2018.04.011.
PubMed 30055710Cradock AL, Barrett JL, Giles CM, Lee RM, Kenney EL, deBlois ME, Thayer JC, Gortmaker SL. Promoting Physical Activity With the Out of School Nutrition and Physical Activity (OSNAP) Initiative: A Cluster-Randomized Controlled Trial. JAMA Pediatr. 2016 Feb;170(2):155-62. doi: 10.1001/jamapediatrics.2015.3406.
PubMed 26641557Lee RM, Emmons KM, Okechukwu CA, Barrett JL, Kenney EL, Cradock AL, Giles CM, deBlois ME, Gortmaker SL. Validity of a practitioner-administered observational tool to measure physical activity, nutrition, and screen time in school-age programs. Int J Behav Nutr Phys Act. 2014 Nov 28;11:145. doi: 10.1186/s12966-014-0145-5.
PubMed 25429898Giles CM, Kenney EL, Gortmaker SL, Lee RM, Thayer JC, Mont-Ferguson H, Cradock AL. Increasing water availability during afterschool snack: evidence, strategies, and partnerships from a group randomized trial. Am J Prev Med. 2012 Sep;43(3 Suppl 2):S136-42. doi: 10.1016/j.amepre.2012.05.013.
PubMed 22898163
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Out of School Nutrition and Physical Activity Environments
- ClinicalTrials.gov ID
- NCT01396473
- Acronym / sponsor ID
- OSNAP / 18046
- Conditions
- Child Physical Activity, Child Nutrition
- Keywords
- afterschool, accelerometers, plate waste, policy, environment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 18 Jul 2011 (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 design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.
Detailed description
Nearly half of Boston's school age children (49%) participate in out of school time programs, a critical time to intervene on physical activity and nutrition. Previous research has mostly focused on during-school-day efforts, or on child care policies and practices for very young children, leaving a gap in the knowledge of what might work with programs serving school-age children during out of school time. OSNAP aims to implement low cost and sustainable policy and environmental interventions to improve physical activity and healthy eating/beverage environments. Data will be collected via observations, plate waste and accelerometers on program policies, environments, practices and behavioral outcomes related to physical activity, beverage, snack and screen time outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| Policy and Environmental Change | Experimental | Behavioral: Policy and Environmental Change |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Afterschool programs in Boston MA serving at least 40 children ages 5-12 years operating the full school year between September and June
- Afterschool programs serving a snack to children
- Children between the ages of 5 and 12 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Policy and Environmental ChangeAfterschool programs participate in an assessment of physical activity and nutrition practices and policies. Study staff work with teams of afterschool programs in a participatory manner to identify areas in which programs would like to take practice, policy and communication efforts to meet physical activity and nutrition goals. Teams share progress and barriers during ongoing collaborative meetings. | Behavioural | Policy and Environmental Change |
Primary outcome
Change in physical activity
Time frame: Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention
Accelerometer and SOPLAY observation
1 secondary outcome
Change in dietary intake
Time frame: Participants' dietary intake will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-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 18 Jul 2011.
- Derived from this study: PubMed 34694005Virgara R, Phillips A, Lewis LK, Baldock K, Wolfenden L, Ferguson T, Richardson M, Okely A, Beets M, Maher C. Interventions in outside-school hours childcare settings for promoting physical activity amongst schoolchildren aged 4 to 12 years. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013380. doi: 10.1002/14651858.CD013380.pub2.
- Derived from this study: PubMed 30055710Lee RM, Giles CM, Cradock AL, Emmons KM, Okechukwu C, Kenney EL, Thayer J, Gortmaker SL. Impact of the Out-of-School Nutrition and Physical Activity (OSNAP) Group Randomized Controlled Trial on Children's Food, Beverage, and Calorie Consumption among Snacks Served. J Acad Nutr Diet. 2018 Aug;118(8):1425-1437. doi: 10.1016/j.jand.2018.04.011.
- Derived from this study: PubMed 26641557Cradock AL, Barrett JL, Giles CM, Lee RM, Kenney EL, deBlois ME, Thayer JC, Gortmaker SL. Promoting Physical Activity With the Out of School Nutrition and Physical Activity (OSNAP) Initiative: A Cluster-Randomized Controlled Trial. JAMA Pediatr. 2016 Feb;170(2):155-62. doi: 10.1001/jamapediatrics.2015.3406.
- Derived from this study: PubMed 25429898Lee RM, Emmons KM, Okechukwu CA, Barrett JL, Kenney EL, Cradock AL, Giles CM, deBlois ME, Gortmaker SL. Validity of a practitioner-administered observational tool to measure physical activity, nutrition, and screen time in school-age programs. Int J Behav Nutr Phys Act. 2014 Nov 28;11:145. doi: 10.1186/s12966-014-0145-5.
- Derived from this study: PubMed 22898163Giles CM, Kenney EL, Gortmaker SL, Lee RM, Thayer JC, Mont-Ferguson H, Cradock AL. Increasing water availability during afterschool snack: evidence, strategies, and partnerships from a group randomized trial. Am J Prev Med. 2012 Sep;43(3 Suppl 2):S136-42. doi: 10.1016/j.amepre.2012.05.013.
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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.
Steven Gortmaker, PhD principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Policy and Environmental Change in people with Child Physical Activity and Child Nutrition, run by Harvard School of Public Health (HSPH) 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 0 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 18 Jul 2011. 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?
Change in physical activity (time frame: Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days 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 NCT01396473, which also lists 5 linked publications.
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 18 Jul 2011.