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Community-based Adolescent Diabetes Prevention Program

20. november 2019 oppdatert av: Icahn School of Medicine at Mount Sinai

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10029
        • Icahn School of Medicine at Mount Sinai

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria for pre-diabetes screening:

  • Adolescents ages 13-19 years of age
  • English speaking

  • Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:

    1. attending a school in East Harlem
    2. attending an after school or recreational activity in East Harlem
    3. receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
  • At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
  • No plans to relocate from New York City in the next year

Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test

Exclusion Criteria for pre-diabetes screening:

  • <13 or >19 years of age
  • Previous diagnosis of diabetes
  • BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
  • Currently pregnant
  • Speaking a language other than English
  • On medications that may raise or lower blood sugar
  • Plans to relocate from New York City within one year of enrollment-

Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TEEN HEED
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites. The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
Atferdsmessig: TEEN HEED
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
Ingen inngripen: Wait List Control
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in body mass index (BMI)
Tidsramme: Baseline and 3 months
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in BMI
Tidsramme: Baseline and 1 year
Change in BMI at 1 year as compared to baseline
Baseline and 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in fasting blood glucose levels
Tidsramme: Baseline and 3 months
Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in fasting blood glucose levels
Tidsramme: Baseline and 1 year
Change in fasting blood glucose levels at 1 year as compared to baseline
Baseline and 1 year
Change in post prandial blood glucose level
Tidsramme: Baseline and 3 months
Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in post prandial blood glucose level
Tidsramme: Baseline and 1 year
Change in post prandial blood glucose level at 1 year as compared to baseline
Baseline and 1 year
Change in blood pressure
Tidsramme: Baseline and 3 months
Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in blood pressure
Tidsramme: Baseline and 1 year
Change in blood pressure at 1 year as compared to baseline
Baseline and 1 year
Change in percent body fat
Tidsramme: Baseline and 3 months
Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in percent body fat
Tidsramme: Baseline and 1 year
Change in percent body fat at 1 year as compared to baseline
Baseline and 1 year
Change in waist circumference
Tidsramme: Baseline and 3 months
Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in waist circumference
Tidsramme: Baseline and 1 year
Change in waist circumference at 1 year as compared to baseline
Baseline and 1 year
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Tidsramme: Baseline and 3 months
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Tidsramme: Baseline and 1 year
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
Baseline and 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Icahn School of Medicine at Mount Sinai

Samarbeidspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Etterforskere

  • Hovedetterforsker: Nita Vangeepuram, MD, MPH, Icahn School of Medicine at Mount Sinai

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. november 2016

Primær fullføring (Faktiske)

24. august 2019

Studiet fullført (Faktiske)

24. august 2019

Datoer for studieregistrering

Først innsendt

22. mai 2015

Først innsendt som oppfylte QC-kriteriene

27. mai 2015

Først lagt ut (Anslag)

29. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. november 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GCO 13-0901
  • 5K23DK101692-02 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Pre-diabetes

Kliniske studier på TEEN HEED

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