Stanford Kids CAMP Study

Last updated: May 14, 2022
Sponsor: Stanford University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

N/A

Clinical Study ID

NCT05380817
65748
  • Ages 5-13
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 5-13 years of age.
  • Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing thecontinuous glucose monitor.
  • Willingness to wear a continuous glucose sensor and physiological monitor for theduration of the study.
  • A parent/caregiver is available for system training and will commit to be the mainresponsible person for the use of the monitoring system at home.

Exclusion

Exclusion Criteria:

  • Have a condition limiting their participation in the interventions (e.g., unable toparticipate in routine physical education classes at school, requiring oxygensupplementation for exertion, developmental or physical disability preventingparticipation in interventions, children or parents/guardians who cannot medicallyparticipate in mild dietary restrictions and/or increased physical activity for anyreason).
  • Have a condition limiting participation in the assessments (child or primary caregivernot able to read surveys in English or Spanish, child two or more grade levels delayedin school for reading and writing in her native language).
  • Are unable to read, understand or complete informed consent in English or Spanish.
  • Are deemed to have another characteristic that makes them unsuitable for participationin the study in the judgment of the Principal Investigators.

Study Design

Total Participants: 100
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

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