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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02161809
Other study ID # Pro00032881
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2015
Est. completion date August 2018

Study information

Verified date November 2020
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 14 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Year 1 - Year 4
Secondary Change in percentage of children bringing/consuming healthy foods/beverages Trained observers will record the foods/beverages brought/consumed at SDC - snacks and lunches Year 1 - Year 4
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