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Families Preventing Diabetes Together

23 août 2017 mis à jour par: University of Minnesota
The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.

Adult patients and their families will be recruited in two ways:

  1. from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
  2. through MyChart messages informing them about the study.

Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

Type d'étude

Interventionnel

Inscription (Réel)

7

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
    • Minnesota
      • Minneapolis, Minnesota, États-Unis, 55455
        • University of Minnesota, School of Nursing

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

2 ans à 55 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Parent with Type 2 diabetes
  • At least 1 child between the ages of 7-12
  • Parent has completed at least some Diabetes Education through Fairview Health System

Exclusion Criteria:

  • Parent with Type 2 diabetes does not speak or read in English
  • No parents with Type 2 diabetes or no children ages 7-12 years
  • Parent with Type 2 diabetes has not completed at least some Diabetes Education

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: Intervention Group
Families in the Families Preventing Diabetes Together intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
Comportemental: Families Preventing Diabetes Together
Families in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
Aucune intervention: Measurement Only
No intervention only measurements

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Délai: up to 6 months
Ability to successfully recruit 30- 40 families in the study will determine feasibility.
up to 6 months
Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
Délai: up to 6 months
Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
Délai: up to 6 months
Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
up to 6 months
Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
Délai: up to 6 months
Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Délai: up to 6 months
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
up to 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Child BMIz
Délai: up to 6 months
Objectively measured height and weight will be used to determine child BMIz values to see if the study resulted in any changes in BMIz between baseline measurements and post-intervention measurements.
up to 6 months
Blood glucose control in parent with Type 2 diabetes
Délai: up to 6 months
Change in type 2 diabetic parent's A1C values over the course of the study will be used to measure parent blood glucose control between baseline measurements and post-intervention measurements.
up to 6 months

Collaborateurs et enquêteurs

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

Parrainer

University of Minnesota

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

1 février 2016

Achèvement primaire (Réel)

30 juin 2017

Achèvement de l'étude (Réel)

30 juin 2017

Dates d'inscription aux études

Première soumission

16 février 2016

Première soumission répondant aux critères de contrôle qualité

28 mars 2016

Première publication (Estimation)

29 mars 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 août 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 août 2017

Dernière vérification

1 août 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 23085

Plan pour les données individuelles des participants (IPD)

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NON

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