Obesity, ChildhoodNCT04009304
Effective Training Models for Implementing Health-Promoting Practices Afterschool
A study testing OSNAP in people with Obesity, Childhood, run by Harvard School of Public Health (HSPH).
Trial summary
This study of the dissemination of the Out-of-school Nutrition and Physical Activity Initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- OSNAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Staff from afterschool sites that are run by the YMCA
- Staff from afterschool sites that serve elementary age children
- Staff from afterschool sites that run programming for the duration of the school year
Who cannot join
- Staff from afterschool sites that have already had experience implementing the OSNAP intervention
About this study
This study of the dissemination of the Out-of-school Nutrition and Physical Activity Initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. online) for an evidence-based out-of-school time (OST) nutrition and physical activity intervention. The study will compare sites that receive the training models with a control group. Investigators will work with YMCA leadership to recruit 45 demographically diverse YMCA OST sites from across the country. Sites will be matched on racial/ethnic composition, proportion of students eligible for free or reduced price meals, program enrollment, urban/rural/suburban setting, and physical activity and food service facilities available. One-third of the sites will be randomized to participate in the online training over the school year, one-third will participate in the in-person train-the-trainer model, and one-third will serve as controls. After randomization, in fall 2016, teams of YMCA OST directors and line staff will be invited to participate in the OSNAP learning collaborative trainings. The intervention follows the social ecological model with activities targeting multiple levels of change-school district/program sponsor, OST site, interpersonal, and individual-and emphasizing on adoption of the following OSNAP goals: ban sugar-sweetened drinks from snacks served and brought in from outside the snack program; offer water as a drink at snack every day; offer a fruit or vegetable option every day at snack; ban foods with trans fats from snacks served; serve whole grains; offer 30 minutes of physical activity to all children daily; offer 20 minutes of vigorous physical activity to all children 3 times per week; and eliminate television, movies, and non-educational screentime. Sessions are designed consistent with the Institute for Healthcare Improvement Breakthrough Series Collaborative model and use constructs from social cognitive theory-knowledge and skill development coupled with action planning-to drive environmental and behavior change. Teams of afterschool staff will use the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT), decision aids, policy writing guides, and other resources available at www.osnap.org to set data-driven goals and implement discrete practice, policy, and communication action steps throughout the year. Staff will also receive training on the Food \& Fun After School curriculum available at foodandfun.org.
- Conditions
- Obesity, Childhood
- Being tested
- OSNAP
- Keywords
- Nutrition, Physical activity
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSNAPBehavioural
Afterschool practice and policy change to support healthy eating and physical activity
| Study group | Role | What they receive |
|---|---|---|
| In-person | Experimental | OSNAP intervention delivered to afterschool sites using an in-person train-the-trainer model implementation strategy Receives: Behavioral: OSNAP |
| Online | Experimental | OSNAP intervention delivered to afterschool sites using an online training model implementation strategy Receives: Behavioral: OSNAP |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in nutrition and physical activity goals met (aggregate score)
Effectiveness of the intervention will be measured with the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT)-an observational measure of nutrition and physical activity practices that site staff complete for one week before and after the intervention. Our team validated the tool with OST staff similar to those proposed to complete the measure in this study, establishing criterion validity for physical activity and nutrition outcomes with correlations ranging from 0.56 to 0.85 when compared with accelerometry and direct observation of dietary intake.
Minimum goals possible: 0; Maximum goals possible: 9 Higher values represent better outcomes
Measured: Measured pre/post about 6 months apart
Secondary outcomes (1)
Change from baseline in % of days offering physical activity, screentime, fruits and vegetables, water, juice, whole grains, and sugary drinks from outside the program
Using same Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT measure) - components of aggregate score Minimum days possible: 0%; Maximum days possible: 100% Higher values represent better outcomes
Measured: Measured pre/post about 6 months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study startSep 2016
- Primary completionJul 2017
- Study completionSep 2017
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 Obesity, ChildhoodStudies 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
- Model description
- Assigned afterschool sites (not individual participants) to group with block randomization approach, delayed intervention design offered effective intervention to control group in year 2
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebekka Lee, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009304
- Sponsor's protocol ID
- 6928483
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee RM, Barrett JL, Daly JG, Mozaffarian RS, Giles CM, Cradock AL, Gortmaker SL. Assessing the effectiveness of training models for national scale-up of an evidence-based nutrition and physical activity intervention: a group randomized trial. BMC Public Health. 2019 Nov 28;19(1):1587. doi: 10.1186/s12889-019-7902-y.
PubMed 31779603
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Training Models for Implementing Health-Promoting Practices Afterschool
- ClinicalTrials.gov ID
- NCT04009304
- Acronym / sponsor ID
- 6928483
- Conditions
- Obesity, Childhood
- Keywords
- Nutrition, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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 of the dissemination of the Out-of-school Nutrition and Physical Activity Initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. online) for an evidence-based out-of-school time (OST) nutrition and physical activity intervention. The study will compare sites that receive the training models with a control group. Investigators will work with YMCA leadership to recruit 45 demographically diverse YMCA OST sites from across the country. Sites will be matched on racial/ethnic composition, proportion of students eligible for free or reduced price meals, program enrollment, urban/rural/suburban setting, and physical activity and food service facilities available. One-third of the sites will be randomized to participate in the online training over the school year, one-third will participate in the in-person train-the-trainer model, and one-third will serve as controls. After randomization, in fall 2016, teams of YMCA OST directors and line staff will be invited to participate in the OSNAP learning collaborative trainings. The intervention follows the social ecological model with activities targeting multiple levels of change-school district/program sponsor, OST site, interpersonal, and individual-and emphasizing on adoption of the following OSNAP goals: ban sugar-sweetened drinks from snacks served and brought in from outside the snack program; offer water as a drink at snack every day; offer a fruit or vegetable option every day at snack; ban foods with trans fats from snacks served; serve whole grains; offer 30 minutes of physical activity to all children daily; offer 20 minutes of vigorous physical activity to all children 3 times per week; and eliminate television, movies, and non-educational screentime. Sessions are designed consistent with the Institute for Healthcare Improvement Breakthrough Series Collaborative model and use constructs from social cognitive theory-knowledge and skill development coupled with action planning-to drive environmental and behavior change. Teams of afterschool staff will use the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT), decision aids, policy writing guides, and other resources available at www.osnap.org to set data-driven goals and implement discrete practice, policy, and communication action steps throughout the year. Staff will also receive training on the Food \& Fun After School curriculum available at foodandfun.org.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Assigned afterschool sites (not individual participants) to group with block randomization approach, delayed intervention design offered effective intervention to control group in year 2
| Arm | Type | Receives |
|---|---|---|
| In-person | Experimental | Behavioral: OSNAPOSNAP intervention delivered to afterschool sites using an in-person train-the-trainer model implementation strategy |
| Online | Experimental | Behavioral: OSNAPOSNAP intervention delivered to afterschool sites using an online training model implementation strategy |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Staff from afterschool sites that are run by the YMCA
- Staff from afterschool sites that serve elementary age children
- Staff from afterschool sites that run programming for the duration of the school year
Key exclusion criteria (1 listed)
- Staff from afterschool sites that have already had experience implementing the OSNAP intervention
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 |
|---|---|---|
| OSNAPAfterschool practice and policy change to support healthy eating and physical activity | Behavioural | In-person, Online |
Primary outcome
Change from baseline in nutrition and physical activity goals met (aggregate score)
Time frame: Measured pre/post about 6 months apart
Effectiveness of the intervention will be measured with the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT)-an observational measure of nutrition and physical activity practices that site staff complete for one week before and after the intervention. Our team validated the tool with OST staff similar to those proposed to complete the measure in this study, establishing criterion validity for physical activity and nutrition outcomes with correlations ranging from 0.56 to 0.85 when compared with accelerometry and direct observation of dietary intake. Minimum goals possible: 0; Maximum goals possible: 9 Higher values represent better outcomes
1 secondary outcome
Change from baseline in % of days offering physical activity, screentime, fruits and vegetables, water, juice, whole grains, and sugary drinks from outside the program
Time frame: Measured pre/post about 6 months apart
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 Jul 2019.
- Derived from this study: PubMed 31779603Lee RM, Barrett JL, Daly JG, Mozaffarian RS, Giles CM, Cradock AL, Gortmaker SL. Assessing the effectiveness of training models for national scale-up of an evidence-based nutrition and physical activity intervention: a group randomized trial. BMC Public Health. 2019 Nov 28;19(1):1587. doi: 10.1186/s12889-019-7902-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OSNAP in people with Obesity, Childhood, run by Harvard School of Public Health (HSPH).
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 1 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 Jul 2019. 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 from baseline in nutrition and physical activity goals met (aggregate score) (time frame: Measured pre/post about 6 months apart). 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 NCT04009304, 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 Jul 2019.