Stanford Kids CAMP Study

NCT05380817 | Unknown

• 1 other identifier: 65748
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes; Obesity; Type-2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Duration of initial participant screening

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

• Report of issues and concerns 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

  Baseline through Visit 6 (days 1 through 14)

• Participant perceived use of study technology

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

• At-home urine specimen collection

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

Study Arms (2)

BAWSI Group

OTHER

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

Other: Remote Monitoring Program

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.

Other: Remote Monitoring Program

Interventions

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

BAWSI Group; YMCA of Silicon Valley Group

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Glucose Intolerance; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karl Sylvester, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grant S Wells, MS

CONTACT

(650) 723-7632; gwells2@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean Maternal Child Health - Research, Professor of Surgery

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 19, 2022
• Study Start: July 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data is currently unavailable.

Locations

US (1)