Stanford Kids CAMP Study

Obesity Clinical Trial

Official title:

Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05380817
• Other study ID #: 65748
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: Grant S Wells, MS
• Phone: (650) 723-7632
• Email: gwells2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Pre-diabetes
• Prediabetic State
• Type-2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Participant perceived use of study technology	Percentage of survey responses	Visit 6 (day 14, up to 15 minutes to complete survey)
Secondary	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)
Secondary	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)
Secondary	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)