Childhood ObesityNCT02144519
Physical Activity and Nutrition Intervention in Afterschool Programs
A study testing Healthy Eating and Physical Activity in people with Childhood Obesity, run by University of South Carolina.
Trial summary
The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide. The investigators objective here is two fold. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- 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
- 2,635 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Programs that:
- Operate immediately after the school day
- Operate every day of the school year for a minimum of 2 hours
- Serve a minimum of 30 children of elementary age (6-12 years)
- Operate in a school, community or faith Setting
- Provide a snack
Show all 10Show fewer
- Provide homework assistance/completion time
- Provide enrichment
- Provide opportunities for physical activity
- All children enrolled, staff, and afterschool program (ASP) leaders in the ASPs were eligible to participate in the study.
Who cannot join
- Programs that:
- Were singularly focused
- Programs that were physical activity focused
- Children that:
- Have any physical and/or orthopedic impairment that would limit a child's ability to participate in regular physical activity.
About this study
Official title: Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
The investigators long-term goal is to advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide. The investigators objective here is two fold. First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served. This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard). Second, the investigators will examine the barriers and facilitators to implementing these strategies. The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.
Read the detailed description
The investigators will use a 3-year delayed treatment, cluster randomized controlled trial design with 20 ASPs that serve mostly low-income and minority children (approximately 1300 children ages 6-12yrs) in Columbia, SC and address the following specific aims: Aim 1. Evaluate the impact of a staff-level intervention, a professional development training program focused on core competencies to promote physical activity, on children's physical activity levels; Aim 2. Evaluate the impact of a site-level intervention, a snack modification program that includes a discount buying program, on the quality of snacks served and consumed; and Aim 3. Evaluate the implementation of the staff-level and site-level interventions and identify organizational, staff, and setting characteristics that influence the process of implementing these strategies.
- 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 |
|---|---|---|
| Immediate Intervention | Experimental | Over the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3). Receives: Behavioral: Healthy Eating and Physical Activity |
| Delayed Intervention | Experimental | Over the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year. 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 Percentage 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. The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry. All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+. The accelerometers were distilled using 5-second epochs. When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on). Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off). Children wore the monitors for their entire attendance at the ASPs. Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior. Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.
Measured: Spring of Year 1, Year 2, and 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. These analyses were performed at the ASP level with a sample size of 20 (10 per arm)
Measured: Spring of Year 1, Year 2, and Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- 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
- NCT02144519
- Sponsor's protocol ID
- 1R01HL112787-01A1
- Other IDs
- 1R01HL112787-01A1
- Status last verified
- Nov 2020
- First submitted
- 13 May 2014
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Bottai M, Chandler J, Brazendale K, Beighle A. Physical activity outcomes in afterschool programs: A group randomized controlled trial. Prev Med. 2016 Sep;90:207-15. doi: 10.1016/j.ypmed.2016.07.002. Epub 2016 Jul 7.
PubMed 27397608Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Freedman D, Hutto B, Moore JB, Beighle A. Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs. Am J Health Promot. 2016 Sep;30(7):521-31. doi: 10.4278/ajhp.141001-QUAN-486. Epub 2016 Jun 17.
PubMed 26158679Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Beighle A. Making policy practice in afterschool programs: a randomized controlled trial on physical activity changes. Am J Prev Med. 2015 Jun;48(6):694-706. doi: 10.1016/j.amepre.2015.01.012.
PubMed 25998921
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Physical Activity Policies, Obesogenic Behaviors and Weight Outcomes
- ClinicalTrials.gov ID
- NCT02144519
- Acronym / sponsor ID
- 1R01HL112787-01A1
- Conditions
- Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,635 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Posted 31 Jan 2018
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 advance the adoption and successful implementation of policies that promote PA and nutrition in after school programs (ASP) nationwide. The investigators objective here is two fold. First, the investigators will test the effectiveness of two promising strategies designed to 1) increase the amount of PA children accumulate while attending an ASP and 2) promote changes in the nutritional quality of the snacks served. This represents a fundamental step in establishing practice-based guidelines (best practices) for the uptake and achievement of public health policy goals (CA and Harvard). Second, the investigators will examine the barriers and facilitators to implementing these strategies. The expected outcome of this study is evidence supporting best practices for ASPs to employ to meet policy goals.
Detailed description
The investigators will use a 3-year delayed treatment, cluster randomized controlled trial design with 20 ASPs that serve mostly low-income and minority children (approximately 1300 children ages 6-12yrs) in Columbia, SC and address the following specific aims: Aim 1. Evaluate the impact of a staff-level intervention, a professional development training program focused on core competencies to promote physical activity, on children's physical activity levels; Aim 2. Evaluate the impact of a site-level intervention, a snack modification program that includes a discount buying program, on the quality of snacks served and consumed; and Aim 3. Evaluate the implementation of the staff-level and site-level interventions and identify organizational, staff, and setting characteristics that influence the process of implementing these strategies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Healthy Eating and Physical ActivityOver the 3 year project, this arm receives the Healthy Eating and Physical Activity intervention after year 1 (baseline) for a total of 2 years (year 2 and 3). |
| Delayed Intervention | Experimental | Behavioral: Healthy Eating and Physical ActivityOver the 3 year project, this arm serves as the no treatment control/comparison group for year 1 and 2 (2 years of baseline) and receives the Healthy Eating and Physical Activity intervention in year 3 for a total of 1 year. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Operate immediately after the school day
- Operate every day of the school year for a minimum of 2 hours
- Serve a minimum of 30 children of elementary age (6-12 years)
- Operate in a school, community or faith Setting
- Provide a snack
Key exclusion criteria (5 listed)
- Programs that:
- Were singularly focused
- Programs that were physical activity focused
- Have any physical and/or orthopedic impairment that would limit a child's ability to participate in regular 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 |
|---|---|---|
| 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 | Delayed Intervention, Immediate Intervention |
Primary outcome
Change in Percentage of Children Meeting Physical Activity Policy
Time frame: Spring of Year 1, Year 2, and 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. The primary physical activity (PA) and sedentary behavior outcome was derived via accelerometry. All children attending an ASP on unannounced measurement days had an opportunity to wear the ActiGraph GT3X+. The accelerometers were distilled using 5-second epochs. When children arrived to a program, they were fitted with an accelerometer and the arrival time was recorded (monitor time on). Before a child departed from a program, research staff removed the belt and recorded the time of departure (monitor time off). Children wore the monitors for their entire attendance at the ASPs. Cutpoint thresholds associated with moderate and vigorous activity were used to distill the PA intensity levels and sedentary behavior. Children were considered to have a valid day of accelerometer data if their total wear time (time off minus time on) was ≥60 minutes.
1 secondary outcome
Changes in Nutritional Quality of Snacks
Time frame: Spring of Year 1, Year 2, and Year 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27397608Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Bottai M, Chandler J, Brazendale K, Beighle A. Physical activity outcomes in afterschool programs: A group randomized controlled trial. Prev Med. 2016 Sep;90:207-15. doi: 10.1016/j.ypmed.2016.07.002. Epub 2016 Jul 7.
- Derived from this study: PubMed 26158679Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Freedman D, Hutto B, Moore JB, Beighle A. Making Healthy Eating Policy Practice: A Group Randomized Controlled Trial on Changes in Snack Quality, Costs, and Consumption in After-School Programs. Am J Health Promot. 2016 Sep;30(7):521-31. doi: 10.4278/ajhp.141001-QUAN-486. Epub 2016 Jun 17.
- Derived from this study: PubMed 25998921Beets MW, Weaver RG, Turner-McGrievy G, Huberty J, Ward DS, Pate RR, Freedman D, Hutto B, Moore JB, Beighle A. Making policy practice in afterschool programs: a randomized controlled trial on physical activity changes. Am J Prev Med. 2015 Jun;48(6):694-706. doi: 10.1016/j.amepre.2015.01.012.
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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
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.
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 10 inclusion and 5 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 16 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Percentage of Children Meeting Physical Activity Policy (time frame: Spring of Year 1, Year 2, and 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 NCT02144519, which also lists 3 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 16 Nov 2020.