NCT05380817

Stanford Kids CAMP Study

Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 5 Years – 13 Years
• Healthy volunteers: Accepted

Summary

The Stanford Kids CAMP study aims to evaluate the feasibility of enrolling minority participants in school age children (5-13 years old) in a community summer camp setting along with the efficiency by which each participant's biologic specimens are collected. Using remote monitoring technologies and through partnering with community-based organizations, the investigators hypothesize that an increase in underrepresented minority participation in a clinical trial that is greater than the national average is possible.

Detailed description

The proposed study is an outpatient prospective, open-label clinical trial comparing 2 groups: Group 1 (aka BAWSI Camp): the Dexcom G6 Pro Continuous Glucose Monitor and the accelerometer and mobile connected device, Group 2 (aka YMCA of Silicon Valley Camp): the Abbott FreeStyle Libre 2 Continuous Glucose Monitor and the accelerometer and mobile connected device. Eligible subjects will be enrolled to each cohort based on their participation in the specific YMCA camp site. The investigators will study up to 100 minority school-age children (5 - 13 years old) in the San Francisco Bay Area a 5-day summer camp. The study will be split in 2 sequential phases: (A) the BAWSI camp, (B) the YMCA of Silicon Valley camp, following a repeated measures design with the 5-day camp being followed by 5 - 9 days at home, under parental supervision. Study participants will be divided in two equal groups at each site with each wearing the specific manufacturers continuous glucose monitoring device.

Conditions

• Pre-diabetes
• Obesity
• Type-2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Remote Monitoring Program	Participants receive remote monitoring while engaging in a theory-based, multi-component, multi-level, multi-setting (MMM) community team sports program designed specifically for children

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-08-31
• Completion: 2022-12-31
• First posted: 2022-05-19
• Last updated: 2022-05-19

Locations

1 site across 1 country: United States