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Community-based Adolescent Diabetes Prevention Program

20 november 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • New York, New York, Förenta staterna, 10029
        • Icahn School of Medicine at Mount Sinai

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

13 år till 19 år (Barn, Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: TEEN HEED
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in fasting blood glucose levels
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline and 1 year
Change in blood pressure at 1 year as compared to baseline
Baseline and 1 year
Change in percent body fat
Tidsram: 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
Tidsram: Baseline and 1 year
Change in percent body fat at 1 year as compared to baseline
Baseline and 1 year
Change in waist circumference
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Icahn School of Medicine at Mount Sinai

Samarbetspartners

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

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2016

Primärt slutförande (Faktisk)

24 augusti 2019

Avslutad studie (Faktisk)

24 augusti 2019

Studieregistreringsdatum

Först inskickad

22 maj 2015

Först inskickad som uppfyllde QC-kriterierna

27 maj 2015

Första postat (Uppskatta)

29 maj 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 november 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 november 2019

Senast verifierad

1 november 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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