- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464015
Feasibility and Acceptability of a Pediatric Referral to Summer Day Camps to Treat Obesity in Children From Low-Income Households
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Keith Brazendale, PhD
- Phone Number: 4078230786
- Email: keith.brazendale@ucf.edu
Study Locations
-
-
Florida
-
Orlando, Florida, United States, 32816
- Recruiting
- University of Central Florida
-
Contact:
- Keith Brazendale, PhD
- Phone Number: 4078230786
- Email: keith.brazendale@ucf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Overweight or Obese
- Attends pediatric clinic
- Medicaid Insured
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Summer Day Camp Voucher
Children (n=40) randomized to the experimental arm will receive a voucher 'referral' from a pediatrician or nurse practitioner to attend an existing summer day camp for 8 weeks free-of- charge
|
Attendance at a Boys and Girls Club of Central Florida summer day camp
|
|
No Intervention: Control
Children (n=40) randomized to the control group arm will continue summer as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height in centimeters
Time Frame: Baseline (pre-summer) and Follow-Up (3 months post-baseline)
|
Height in centimeters will be captured via a stadiometer at baseline (pre-summer) and follow-up (post summer) approximately 12 weeks apart for children in the treatment and control group.
Height and weight measurements will be aggregated to arrive at Body Mass Index (BMI) in kg/m^2.
|
Baseline (pre-summer) and Follow-Up (3 months post-baseline)
|
|
Weight in kilograms
Time Frame: Baseline (pre-summer) and Follow-Up (3 months post-baseline)
|
Weight in kilograms will be captured via the Tanita C-300 scale at baseline (pre-summer) and follow-up (post summer) approximately 12 weeks apart for children in the treatment and control group.
Height and weight measurements will be aggregated to arrive at Body Mass Index (BMI) in kg/m^2.
|
Baseline (pre-summer) and Follow-Up (3 months post-baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Obesogenic Behaviors - Physical Activity
Time Frame: 14-day observation period
|
Summer differences in physical activity between children in treatment and control group. Each study participant will wear the Actigraph Link on their non-dominant wrist for 14 days. The device is waterproof, allowing us to capture water-based activities during summer, and is extensively used in free-living child-focused studies. |
14-day observation period
|
|
Obesogenic Behaviors - Sleep
Time Frame: 14-day observation period
|
Summer differences in sleep between children in treatment and control group. Each study participant will wear the Actigraph Link on their non-dominant wrist for 14 days. This extensively used in free-living child-focused studies for sleep. |
14-day observation period
|
|
Obesogenic Behaviors - Diet
Time Frame: 14-day observation period
|
The Beverage and Snack Questionnaire (BSQ) will capture reported consumption of Healthy Meal Index food categories, such as sugar-sweetened beverages, salty snacks, sweets, milk, fruit, and vegetables each day.
Parents will complete one per day, in consultation with their child, for 14-days.
|
14-day observation period
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00008221
- 1R21NR021423-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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