Families Preventing Diabetes Together
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota, School of Nursing
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
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: 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.
|
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.
|
|
Inget ingripande: Measurement Only
No intervention only measurements
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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).
Tidsram: 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.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Child BMIz
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 23085
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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 .