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Stanford Kids CAMP Study

14. maj 2022 opdateret af: Karl Sylvester, Stanford University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

5 år til 13 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: BAWSI Group
By partnering with a community sports club (BAWSI), will the partnership recruitment model be effective in enrolling minority children.
Andet: 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
Andet: 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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of underrepresented minority participants enrolled
Tidsramme: Baseline (prior to arrival at camp)
Percentage of underrepresented minority participants enrolled compared to the U.S. national average.
Baseline (prior to arrival at camp)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of initial participant screening
Tidsramme: Visit 1 (day 1, up to 60 minutes for 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
Tidsramme: Visit 4, Visit 6 (days 6 and 14, up to 30 minutes to complete survey)
# 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
Tidsramme: Baseline through Visit 6 (days 1 through 14)
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
Tidsramme: Visit 6 (day 14, up to 15 minutes to complete survey)
Percentage of survey responses
Visit 6 (day 14, up to 15 minutes to complete survey)
At-home urine specimen collection
Tidsramme: Visit 1, Visit 3 (collected on days 1 and 5)
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
Tidsramme: Baseline through Visit 6 (days 1 though 14)
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
Tidsramme: Visit 1, Visit 2, Visit 3 (days 1 though 5)
This measure is intended to evaluate study device performance during summer camp
Visit 1, Visit 2, Visit 3 (days 1 though 5)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Stanford University

Efterforskere

  • Ledende efterforsker: Karl Sylvester, MD, Stanford University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juli 2022

Primær færdiggørelse (Forventet)

31. august 2022

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

9. maj 2022

Først indsendt, der opfyldte QC-kriterier

14. maj 2022

Først opslået (Faktiske)

19. maj 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 65748

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Investigators can request the limited public access data set from the Stanford Metabolic Health Center's Data Coordinating Center

IPD-delingstidsramme

Data is currently unavailable.

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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