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Stanford Kids CAMP Study

Primary Purpose

Pre-diabetes, Obesity, Type-2 Diabetes Mellitus

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Remote Monitoring Program

About this trial

This is an interventional other trial for Pre-diabetes

Eligibility Criteria

5 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

BAWSI Group

YMCA of Silicon Valley Group

Arm Description

By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children.

By partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children.

Outcomes

Primary Outcome Measures

Percentage of underrepresented minority participants enrolled

Percentage of underrepresented minority participants enrolled compared to the U.S. national average.

Secondary Outcome Measures

Duration of initial participant screening

Average duration of time to screen enrolled subjects on Day 1 of summer camp.

Report of issues and concerns during at-home monitoring period

# of telephone reported incidents and questions during at-home monitoring period.

Physical activity measured by accelerometry

Garmin Vivofit 4 total and after camp physical activity and sedentary behavior

Participant perceived use of study technology

Percentage of survey responses

At-home urine specimen collection

Percentage of enrolled participants who complete at home urine sample collection and bring the sample with them to camp.

Continuous patient monitoring performance

Percentage of total study time children were monitored using glucose and accelerometry devices

Number of patient reported device related issues

This measure is intended to evaluate study device performance during summer camp

Full Information

NCT ID

NCT05380817

First Posted

May 9, 2022

Last Updated

May 14, 2022

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT05380817

Brief Title

Stanford Kids CAMP Study

Official Title

Stanford Kids Continuous Advanced Metabolic Profiling (CAMP) Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2022 (Anticipated)

Primary Completion Date

August 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes, Obesity, Type-2 Diabetes Mellitus

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BAWSI Group

Arm Type

Other

Arm Description

By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children.

Arm Title

YMCA of Silicon Valley Group

Arm Type

Other

Arm Description

By partnering with a community organization (YMCA of Silicon Valley), will the partnership recruitment model be effective in enrolling minority children.

Intervention Type

Other

Intervention Name(s)

Remote Monitoring Program

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of underrepresented minority participants enrolled

Description

Percentage of underrepresented minority participants enrolled compared to the U.S. national average.

Time Frame

Baseline (prior to arrival at camp)

Secondary Outcome Measure Information:

Title

Duration of initial participant screening

Description

Average duration of time to screen enrolled subjects on Day 1 of summer camp.

Time Frame

Visit 1 (day 1, up to 60 minutes for screening)

Title

Report of issues and concerns during at-home monitoring period

Description

# of telephone reported incidents and questions during at-home monitoring period.

Time Frame

Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey)

Title

Physical activity measured by accelerometry

Description

Garmin Vivofit 4 total and after camp physical activity and sedentary behavior

Time Frame

Baseline through Visit 6 (days 1 through 14)

Title

Participant perceived use of study technology

Description

Percentage of survey responses

Time Frame

Visit 6 (day 14, up to 15 minutes to complete survey)

Title

At-home urine specimen collection

Description

Percentage of enrolled participants who complete at home urine sample collection and bring the sample with them to camp.

Time Frame

Visit 1, Visit 3 (collected on days 1 and 5)

Title

Continuous patient monitoring performance

Description

Percentage of total study time children were monitored using glucose and accelerometry devices

Time Frame

Baseline through Visit 6 (days 1 though 14)

Title

Number of patient reported device related issues

Description

This measure is intended to evaluate study device performance during summer camp

Time Frame

Visit 1, Visit 2, Visit 3 (days 1 though 5)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Grant S Wells, MS

Phone

(650) 723-7632

gwells2@stanford.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Sylvester, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Grant S Wells, MS

Phone

650-723-7632

gwells2@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Stanford Kids CAMP Study

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