Turn up the HEAT - Healthy Eating and Activity Time in Summer Day Camps (HEPA)

November 16, 2020 updated by: Michael Beets, University of South Carolina

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Physical Activity Intervention
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.
Behavioral: Healthy Eating and Physical Activity
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.
Other Names:
  • HEPA
Other: Healthy EAting Intervention
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.
Behavioral: Healthy Eating and Physical Activity
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.
Other Names:
  • HEPA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Year 1 - Year 4

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in percentage of children bringing/consuming healthy foods/beverages
Time Frame: Year 1 - Year 4
Trained observers will record the foods/beverages brought/consumed at SDC - snacks and lunches
Year 1 - Year 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael W Beets, PhD, University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00032881

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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