Families Preventing Diabetes Together
23 agosto 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
7
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- University of Minnesota, School of Nursing
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 2 anni a 55 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Measurement Only
No intervention only measurements
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Child BMIz
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2016
Completamento primario (Effettivo)
30 giugno 2017
Completamento dello studio (Effettivo)
30 giugno 2017
Date di iscrizione allo studio
Primo inviato
16 febbraio 2016
Primo inviato che soddisfa i criteri di controllo qualità
28 marzo 2016
Primo Inserito (Stima)
29 marzo 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 agosto 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
23 agosto 2017
Ultimo verificato
1 agosto 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 23085
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .