Families Preventing Diabetes Together
23. august 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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:
- from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
- 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
7
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota, School of Nursing
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 55 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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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.
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Ingen indgriben: Measurement Only
No intervention only measurements
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Tidsramme: up to 6 months
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Ability to successfully recruit 30- 40 families in the study will determine feasibility.
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up to 6 months
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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.
Tidsramme: up to 6 months
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Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
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up to 6 months
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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.
Tidsramme: up to 6 months
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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.
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up to 6 months
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Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
Tidsramme: up to 6 months
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Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
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up to 6 months
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Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Tidsramme: up to 6 months
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Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
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up to 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Child BMIz
Tidsramme: up to 6 months
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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.
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up to 6 months
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Blood glucose control in parent with Type 2 diabetes
Tidsramme: up to 6 months
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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.
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up to 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2016
Primær færdiggørelse (Faktiske)
30. juni 2017
Studieafslutning (Faktiske)
30. juni 2017
Datoer for studieregistrering
Først indsendt
16. februar 2016
Først indsendt, der opfyldte QC-kriterier
28. marts 2016
Først opslået (Skøn)
29. marts 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 23085
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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