Stanford Kids CAMP Study

Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Pre-diabetes; Type-2 Diabetes Mellitus
• Intervention / Treatment: Other: Remote Monitoring Program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grant S Wells, MS; Phone Number: (650) 723-7632; Email: gwells2@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
      • Contact: Grant S Wells, MS; Phone Number: 650-723-7632; Email: gwells2@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Have a condition limiting their participation in the interventions (e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason).
• Have a condition limiting participation in the assessments (child or primary caregiver not able to read surveys in English or Spanish, child two or more grade levels delayed in 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 participation in the study in the judgment of the Principal Investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: BAWSI Group; By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children.	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
Other: YMCA of Silicon Valley Group; By partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of underrepresented minority participants enrolled	Percentage of underrepresented minority participants enrolled compared to the U.S. national average.	Baseline (prior to arrival at camp)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of initial participant screening	Average duration of time to screen enrolled subjects on Day 1 of summer camp.	Visit 1 (day 1, up to 60 minutes for screening)
Report of issues and concerns during at-home monitoring period	# of telephone reported incidents and questions during at-home monitoring period.	Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey)
Physical activity measured by accelerometry	Garmin Vivofit 4 total and after camp physical activity and sedentary behavior	Baseline through Visit 6 (days 1 through 14)
Participant perceived use of study technology	Percentage of survey responses	Visit 6 (day 14, up to 15 minutes to complete survey)
At-home urine specimen collection	Percentage of enrolled participants who complete at home urine sample collection and bring the sample with them to camp.	Visit 1, Visit 3 (collected on days 1 and 5)
Continuous patient monitoring performance	Percentage of total study time children were monitored using glucose and accelerometry devices	Baseline through Visit 6 (days 1 though 14)
Number of patient reported device related issues	This measure is intended to evaluate study device performance during summer camp	Visit 1, Visit 2, Visit 3 (days 1 though 5)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Karl Sylvester, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 14, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 14, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: 65748

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Investigators can request the limited public access data set from the Stanford Metabolic Health Center's Data Coordinating Center
• IPD Sharing Time Frame: Data is currently unavailable.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No