Childhood ObesityHEPANCT02161809
Turn up the HEAT - Healthy Eating and Activity Time in Summer Day Camps
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 increase the number of Summer Day Camps (SDC) that meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA) Standards. Read more about this study
- Who is it for?
- Ages 6 to 14 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
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 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 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Summer Day camps will be eligible if:
- They operate for at least 10 weeks during the summer
- They do not have any primary focus such as sports, art, or tutoring (must be a general camp)
- Enrollment is at least 40 campers
- Operation hours are at least 8 hours.
Who cannot join
- Children will be unable to wear an activity monitor if experience any physical and/or orthopedic impairment that limits the child's ability to participate in regular PA (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 increase the number of Summer Day Camps (SDC) that meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA) Standards. The objective is to evaluate the effectiveness of a multi-component intervention designed to increase children's PA levels and improve the quality of lunches and snacks children consume in SDCs. The HEPA intervention is designed to target children, parents, staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC leaders to train their staff to deliver and integrate the intervention into routine practice. In the proposed study, the investigators will evaluate these HEPA strategies, using a 4-year randomized controlled trial with 20 SDCs. An important feature of the study will be the evaluation of maintenance of the intervention after the removal of research support (e.g., training, boosters) during the final year, as well as costs associated with implementation.
The investigators hypothesize that intervention SDCs will achieve significantly greater increases in HEPA, compared to control SDCs. The investigators expect the study to support the cost-effectiveness and maintenance of our strategies for promoting HEPA that will facilitate SDCs meeting newly-established HEPA standards for this setting.
Read the detailed description
The investigators aim to:
Evaluate the impact of the HEPA interventions on: 1.) The proportion of children meeting the PA Standard (i.e., ≥60min MVPA/d) while attending summer day camp; 2.) The proportion of foods (e.g., fruit, vegetable, water) children and staff bring and consume at the summer day camp that meet the HE Standards; and 3/) Changes in children's age-sex specific BMI percentile from the start to end of summer
Evaluate the cost-effectiveness of the HEPA intervention
Evaluate the maintenance of the HEPA intervention in summer day camps
- Conditions
- Childhood Obesity
- Being tested
- Healthy Eating and Physical Activity
- Keywords
- MVPA, Healthy Eating, children, childhood obesity
- 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
The Healthy Eating and Physical Activity (HEPA) intervention aims to increase the quality of foods and beverages and physical activity opportunities in summer day camps. Through staff-level training, physical activity opportunities are modified to provide children with a substantial amount of meaningful physical activity. Through working with foods service providers, changes to the types of foods and beverages served will be made.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | This arm (10 summer day camps) will receive the Physical Activity intervention the first year and both healthy eating and physical activity the second and thrid years. Receives: Behavioral: Healthy Eating and Physical Activity |
| Healthy EAting Intervention | Other | This arm (10 summer day camps) will receive the Healthy Eating intervention the first year and both healthy eating and physical activity the second and thrid years. Receives: Behavioral: Healthy Eating and Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in percentage of children meeting 60min of MVPA
Changes in percentage of children at each summer day camp that meet the National Afterschool Alliance Standard of 60 minutes of moderate-to-vigorous physical activity daily.
Measured: Year 1 - Year 4
Secondary outcomes (1)
Change in percentage of children bringing/consuming healthy foods/beverages
Trained observers will record the foods/beverages brought/consumed at SDC - snacks and lunches
Measured: Year 1 - Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2018
- Study completionAug 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- 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
- NCT02161809
- Sponsor's protocol ID
- Pro00032881
- Acronym
- HEPA
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2014
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weaver RG, Brazendale K, Chandler JL, Turner-McGrievy GM, Moore JB, Huberty JL, Ward DS, Beets MW. First year physical activity findings from turn up the HEAT (Healthy Eating and Activity Time) in summer day camps. PLoS One. 2017 Mar 28;12(3):e0173791. doi: 10.1371/journal.pone.0173791. eCollection 2017.
PubMed 28350830
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
- Turn up the HEAT - Healthy Eating and Activity Time in Summer Day Camps
- ClinicalTrials.gov ID
- NCT02161809
- Acronym / sponsor ID
- HEPA / Pro00032881
- Conditions
- Childhood Obesity
- Keywords
- MVPA, Healthy Eating, children, childhood obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 12 Jun 2014 (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 increase the number of Summer Day Camps (SDC) that meet the National Afterschool Association Healthy Eating and Physical Activity (HEPA) Standards. The objective is to evaluate the effectiveness of a multi-component intervention designed to increase children's PA levels and improve the quality of lunches and snacks children consume in SDCs. The HEPA intervention is designed to target children, parents, staff, program leaders, and the SDC environment and uses a train-the-trainer model with SDC leaders to train their staff to deliver and integrate the intervention into routine practice. In the proposed study, the investigators will evaluate these HEPA strategies, using a 4-year randomized controlled trial with 20 SDCs. An important feature of the study will be the evaluation of maintenance of the intervention after the removal of research support (e.g., training, boosters) during the final year, as well as costs associated with implementation.
The investigators hypothesize that intervention SDCs will achieve significantly greater increases in HEPA, compared to control SDCs. The investigators expect the study to support the cost-effectiveness and maintenance of our strategies for promoting HEPA that will facilitate SDCs meeting newly-established HEPA standards for this setting.
Detailed description
The investigators aim to:
Evaluate the impact of the HEPA interventions on: 1.) The proportion of children meeting the PA Standard (i.e., ≥60min MVPA/d) while attending summer day camp; 2.) The proportion of foods (e.g., fruit, vegetable, water) children and staff bring and consume at the summer day camp that meet the HE Standards; and 3/) Changes in children's age-sex specific BMI percentile from the start to end of summer
Evaluate the cost-effectiveness of the HEPA intervention
Evaluate the maintenance of the HEPA intervention in summer day camps
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Behavioral: Healthy Eating and Physical ActivityThis arm (10 summer day camps) will receive the Physical Activity intervention the first year and both healthy eating and physical activity the second and thrid years. |
| Healthy EAting Intervention | Other | Behavioral: Healthy Eating and Physical ActivityThis arm (10 summer day camps) will receive the Healthy Eating intervention the first year and both healthy eating and physical activity the second and thrid years. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Summer Day camps will be eligible if:
- They operate for at least 10 weeks during the summer
- They do not have any primary focus such as sports, art, or tutoring (must be a general camp)
- Enrollment is at least 40 campers
- Operation hours are at least 8 hours.
Key exclusion criteria (1 listed)
- Children will be unable to wear an activity monitor if experience any physical and/or orthopedic impairment that limits the child's ability to participate in regular PA (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: HEPAThe Healthy Eating and Physical Activity (HEPA) intervention aims to increase the quality of foods and beverages and physical activity opportunities in summer day camps. Through staff-level training, physical activity opportunities are modified to provide children with a substantial amount of meaningful physical activity. Through working with foods service providers, changes to the types of foods and beverages served will be made. | Behavioural | Healthy EAting Intervention, Physical Activity Intervention |
Primary outcome
Changes in percentage of children meeting 60min of MVPA
Time frame: Year 1 - Year 4
Changes in percentage of children at each summer day camp that meet the National Afterschool Alliance Standard of 60 minutes of moderate-to-vigorous physical activity daily.
1 secondary outcome
Change in percentage of children bringing/consuming healthy foods/beverages
Time frame: Year 1 - Year 4
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 28350830Weaver RG, Brazendale K, Chandler JL, Turner-McGrievy GM, Moore JB, Huberty JL, Ward DS, Beets MW. First year physical activity findings from turn up the HEAT (Healthy Eating and Activity Time) in summer day camps. PLoS One. 2017 Mar 28;12(3):e0173791. doi: 10.1371/journal.pone.0173791. eCollection 2017.
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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 5 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?
Changes in percentage of children meeting 60min of MVPA (time frame: Year 1 - Year 4). 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 NCT02161809, 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.