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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAWSI Group | Other | By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children. |
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| YMCA of Silicon Valley Group | Other | By partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Monitoring Program | Other | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grant S Wells, MS | Contact | (650) 723-7632 | gwells2@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karl Sylvester, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
Investigators can request the limited public access data set from the Stanford Metabolic Health Center's Data Coordinating Center
Data is currently unavailable.
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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# 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) |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |