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Community-based Adolescent Diabetes Prevention Program

20 novembre 2019 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • New York, New York, États-Unis, 10029
        • Icahn School of Medicine at Mount Sinai

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

13 ans à 19 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: TEEN HEED
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in body mass index (BMI)
Délai: Baseline and 3 months
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
Baseline and 3 months
Change in BMI
Délai: Baseline and 1 year
Change in BMI at 1 year as compared to baseline
Baseline and 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in fasting blood glucose levels
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 1 year
Change in blood pressure at 1 year as compared to baseline
Baseline and 1 year
Change in percent body fat
Délai: 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
Délai: Baseline and 1 year
Change in percent body fat at 1 year as compared to baseline
Baseline and 1 year
Change in waist circumference
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Icahn School of Medicine at Mount Sinai

Collaborateurs

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

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

11 novembre 2016

Achèvement primaire (Réel)

24 août 2019

Achèvement de l'étude (Réel)

24 août 2019

Dates d'inscription aux études

Première soumission

22 mai 2015

Première soumission répondant aux critères de contrôle qualité

27 mai 2015

Première publication (Estimation)

29 mai 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GCO 13-0901
  • 5K23DK101692-02 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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Essais cliniques sur TEEN HEED

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