Testing the Feasibility and Preliminary Effect of Summer Camp

Childhood Obesity Prevention Clinical Trial

Official title:

Testing the Feasibility and Preliminary Effect of Summer Day Camp on Excess Summer Weight Gain in Children From Low-income Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04085965
• Other study ID #: 710-9073
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: August 22, 2018

Study information

• Verified date: August 2019
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot randomized controlled trial was designed to assess the feasibility and preliminary efficacy of randomizing children, ages 6-12 years from two low-income communities in Rhode Island, to attend a summer day camp (CAMP) or to experience summer as usual (SAU). Children randomized to CAMP attended a Boys and Girls Club summer day camp for 8-weeks in summer 2017 or 2018. As part of the consent process, children randomized to SAU agreed to experience an unstructured summer (i.e. not enroll in more than one week of summer camp, summer school or other structured summer programming). Primary feasibility outcomes included retention, engagement and completion of midsummer measures. Secondary outcomes, change in BMIz (a proxy for excess summer weight gain), physical activity engagement, sedentary behavior, and diet (energy intake and diet quality), were collected by blinded research staff at the end of the school year, midsummer and the end of the summer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 22, 2018
• Est. primary completion date: August 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Qualify for free or reduced-price meals at school

• Speak English (for purposes of camp participation)

• Agree, along with their parent(s), to randomization.

Exclusion Criteria:

• A medical condition that interferes with participation in physical activity

• Enrollment in summer programming (camp, summer school, etc) for more than one week

Related Conditions & MeSH terms

• Childhood Obesity Prevention
• Pediatric Obesity

Intervention

Behavioral:
• Boys and Girls Club summer day camp
Daily camp activities included sports, games, obstacle courses, swimming and boating, summer learning and arts and crafts. Lunch was served daily via the USDA's Summer Food Service Program.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
The Miriam Hospital	Hassenfeld Child Health Innovation Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention	Number of participants who completed both baseline and end of summer assessments	Baseline to end of summer; 8 weeks
Primary	Camp Attendance	Number of days children attended the Boys and Girls Club Camp	8 weeks
Primary	Participation in Summer Activities	Number of days children attended camp, summer school, or day care over the summer	8 weeks
Primary	Completion of study measures	Number of participants who completed three 24-hour diet recalls and/or 7-days of actigraphy at baseline and mid-summer assessment visits	Baseline (May / June); Midsummer (mid-July)
Secondary	Excess summer weight gain	Change in BMIz	Baseline to end of summer; 8 weeks
Secondary	Physical Activity	Change in minutes of moderate to vigorous physical activity (MVPA) as measured by ActiGraph accelerometer	4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Secondary	Sedentary Behavior	Change in percent time spent sedentary as measured by ActiGraph accelerometer	4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Secondary	Energy Intake	Change in total energy intake as measured from 3 non-consecutive 24-hour diet recalls	4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))
Secondary	Diet Quality	Change in Diet Quality as measured by the HEI-2015 from three non-consecutive 24-hour diet recalls	4-6 weeks (from baseline (end of May / beginning of June) to mid-summer (mid-July))