Childhood ObesityNCT02394717
Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards
A study testing Healthy Eating and Physical Activity in people with Childhood Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
The investigators long term-goal is to help YMCA programs across the nation successfully acheive the Y of USA "Healthy Eating and Physical Activity Standards". Our objective here is threefold. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Healthy Eating and Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to May 2018
- 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
- All children enrolled in participating afterschool programs will be eligible to take part in the study.
Who cannot join
- Any physical/orthopedic impairment that would limit a child's ability to participate in regular physical activity (e.g., wheelchair user).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29201
About this study
The investigators long term-goal is to help YMCA programs across the nation successfully acheive the Y of USA "Healthy Eating and Physical Activity Standards". Our objective here is threefold. First, the investigators will work with South Carolina YMCA leadership to achieve the "Healthy Eating and Physical Activity Standards" and implement our HEPA Strategies in YMCA programs across the state, evaluate the uptake of and adherence to the standards and strategies, and identify factors that influence their implementation. Second, the investigators will evaluate the impact of acheiving the standards on children's MVPA and the serving and consumption of FV and water during the programs. Third, the investigators will evaluate the costs associated with and the cost-effectiveness of meeting the standards in terms of improvements in activity and healthy eating.
Read the detailed description
The investigators research team developed a conceptual framework that identifies critical modifiable levers within Out of School Time programs that can be altered and/or strengthened to reach policy or standards goals. These include the policy environment at the national, state and local levels; characteristics of the individual site, program leadership, staff, and children; and existing outside organizational partnerships. This framework was informed by complex systems change, social ecology, systemic capacity building , and the literature on the impact of public health policy that identifies key elements of the system to be targeted as well as possible influences on those elements.
Viewing OST programs as complex systems, "Healthy Eating and Physical Activity Standards" represent one of many leverage points within a system. Existing efforts to implement standards rest solely upon the voluntary adoption of the standards, with little to no other changes to the OST program setting. It is clear from our preliminary work and comprehensive reviews that OST programs are falling short of meeting goals set forth in the standards.
- Conditions
- Childhood Obesity
- Being tested
- Healthy Eating and Physical Activity
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Eating and Physical ActivityBehavioural
Also called HEPA
Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All YMCA programs will receive the Healthy Eating and Physical Activity Intervention throughout the study. All programs will receive the HEPA Strategies intervetion to assist them with achievement of the HEPA Standards. Receives: Behavioral: Healthy Eating and Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of children meeting physical activity policy
We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity
Measured: Baseline, Fall of Year 2, and Fall of Year 3
Secondary outcomes (1)
Changes in Nutritional Quality of Snacks
We will assess quality of snacks served at the ASPs in terms of number of fruits and vegetables served per week.
Measured: Baseline, Fall of Year 2 and Fall of Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionMay 2018
- Study completionMay 2018
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 Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michael Beets, University of South Carolina
- Investigators
- Michael W Beets, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394717
- Sponsor's protocol ID
- Pro00031161
- Other IDs
- 1R01HD079422-01
- Status last verified
- Nov 2020
- First submitted
- 16 Mar 2015
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beets MW, Glenn Weaver R, Brazendale K, Turner-McGrievy G, Saunders RP, Moore JB, Webster C, Khan M, Beighle A. Statewide dissemination and implementation of physical activity standards in afterschool programs: two-year results. BMC Public Health. 2018 Jul 3;18(1):819. doi: 10.1186/s12889-018-5737-6.
PubMed 29970046
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards
- ClinicalTrials.gov ID
- NCT02394717
- Acronym / sponsor ID
- Pro00031161
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 20 Mar 2015 (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 investigators long term-goal is to help YMCA programs across the nation successfully acheive the Y of USA "Healthy Eating and Physical Activity Standards". Our objective here is threefold. First, the investigators will work with South Carolina YMCA leadership to achieve the "Healthy Eating and Physical Activity Standards" and implement our HEPA Strategies in YMCA programs across the state, evaluate the uptake of and adherence to the standards and strategies, and identify factors that influence their implementation. Second, the investigators will evaluate the impact of acheiving the standards on children's MVPA and the serving and consumption of FV and water during the programs. Third, the investigators will evaluate the costs associated with and the cost-effectiveness of meeting the standards in terms of improvements in activity and healthy eating.
Detailed description
The investigators research team developed a conceptual framework that identifies critical modifiable levers within Out of School Time programs that can be altered and/or strengthened to reach policy or standards goals. These include the policy environment at the national, state and local levels; characteristics of the individual site, program leadership, staff, and children; and existing outside organizational partnerships. This framework was informed by complex systems change, social ecology, systemic capacity building , and the literature on the impact of public health policy that identifies key elements of the system to be targeted as well as possible influences on those elements.
Viewing OST programs as complex systems, "Healthy Eating and Physical Activity Standards" represent one of many leverage points within a system. Existing efforts to implement standards rest solely upon the voluntary adoption of the standards, with little to no other changes to the OST program setting. It is clear from our preliminary work and comprehensive reviews that OST programs are falling short of meeting goals set forth in the standards.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Healthy Eating and Physical ActivityAll YMCA programs will receive the Healthy Eating and Physical Activity Intervention throughout the study. All programs will receive the HEPA Strategies intervetion to assist them with achievement of the HEPA Standards. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children enrolled in participating afterschool programs will be eligible to take part in the study.
Key exclusion criteria (1 listed)
- Any physical/orthopedic impairment that would limit a child's ability to participate in regular physical activity (e.g., wheelchair user).
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 |
|---|---|---|
| Healthy Eating and Physical ActivityAlso: HEPACreate partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards. | Behavioural | Intervention |
Primary outcome
Change in proportion of children meeting physical activity policy
Time frame: Baseline, Fall of Year 2, and Fall of Year 3
We will assess the number of children meeting the physical activity policy of 30 minutes or more of moderate-to-vigorous physical activity
1 secondary outcome
Changes in Nutritional Quality of Snacks
Time frame: Baseline, Fall of Year 2 and Fall of Year 3
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 Nov 2020.
- Derived from this study: PubMed 29970046Beets MW, Glenn Weaver R, Brazendale K, Turner-McGrievy G, Saunders RP, Moore JB, Webster C, Khan M, Beighle A. Statewide dissemination and implementation of physical activity standards in afterschool programs: two-year results. BMC Public Health. 2018 Jul 3;18(1):819. doi: 10.1186/s12889-018-5737-6.
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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.
Michael W Beets, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Eating and Physical Activity in people with Childhood Obesity, run by University of South Carolina 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 1 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 18 Nov 2020. 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 proportion of children meeting physical activity policy (time frame: Baseline, Fall of Year 2, and Fall of Year 3). 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 NCT02394717, 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 18 Nov 2020.