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Families Preventing Diabetes Together

23 augustus 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

7

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Minnesota
      • Minneapolis, Minnesota, Verenigde Staten, 55455
        • University of Minnesota, School of Nursing

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 jaar tot 55 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: Measurement Only
No intervention only measurements

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 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.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Child BMIz
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Minnesota

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2016

Primaire voltooiing (Werkelijk)

30 juni 2017

Studie voltooiing (Werkelijk)

30 juni 2017

Studieregistratiedata

Eerst ingediend

16 februari 2016

Eerst ingediend dat voldeed aan de QC-criteria

28 maart 2016

Eerst geplaatst (Schatting)

29 maart 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2017

Laatste update ingediend die voldeed aan QC-criteria

23 augustus 2017

Laatst geverifieerd

1 augustus 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 23085

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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