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Skills for Change: Nutrition Education Program for Emirati Adults With Type 2 Diabetes

8. februar 2020 opdateret af: Habiba I. Ali, United Arab Emirates University

Skills for Change: Implementation of a Community-based Diabetes Nutrition Education Program for Emirati Adults With Type 2 Diabetes

The "Skills for Change" Diabetes Nutrition Education Program was a one-year, community-based conducted in Ambulatory Health Care Services health centers in Al Ain. The project involved nutrition education to improve blood glucose control, diet and physical activity levels of Emirati adults with type 2 diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Despite the high prevalence of diabetes and its complications in the UAE, very few diabetes education intervention studies have been conducted in a representative population in the country. The Skills for Change Program was a one-year, community-based, cluster randomized study involving Emirati adults with type 2 diabetes. We implemented a behavioral lifestyle intervention to improve glycemic control, food choices, and physical activity levels and to decrease sedentarity. The project was culturally adapted to Emirati adults with type 2 diabetes and was driven by theoretical principles of behavior change and education to enhance intervention effectiveness.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

382

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

20 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • United Arab Emirates national
  • Type 2 diabetes
  • Adults: Male and female
  • Age: 20-70 years
  • Attending one of the 7 health centers in Al Ain managed by the Ambulatory Healthcare Services.

Exclusion Criteria:

  • Type 1 diabetes
  • Age >70 Years
  • Medical conditions that prevent active participation in the program, based on recommendation of the attending physicians
  • Participating in other nutrition intervention programs

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention
Behavioral Lifestyle Intervention (3 health centers): In addition to usual care in the health center, the intervention included individual counseling and group education on nutrition and physical activity.
Adfærdsmæssigt: Behavioral Lifestyle Intervention
In addition to usual care in the health center, the intervention included 7 visits with the health center dietitian for individual nutrition counseling, invitation for group nutrition education (5 sessions), individual counseling for physical activity, invitation for a 6-weekly structured group physical activity, DVD on physical activity to perform physical activity at home.
Aktiv komparator: Control
Control (4 health centers): Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months. Visits with the health center dietitian were arranged as per physician referral.
Adfærdsmæssigt: Usual Care
Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months. Visits with the health center dietitian were arranged as per physician referral.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Ændring i Hba1c
Tidsramme: 12 måneder
12 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Cholesterol, LDL, HDL and Triglycerides
Tidsramme: 12 months
12 months
Change in Dietary Intake (Total Calories, Saturated Fat, Cholesterol, Dietary Fiber and Sodium)
Tidsramme: 12 months
Dietary intake was assessed using 24 hour recall with USDA Multiple Pass Method
12 months
Change in Physical Activity (total METs and total duration)
Tidsramme: 12 months
Physical Activity was assessed using International Physical Activity Questionnaire Short Form.
12 months
Change in Sitting time (minutes)
Tidsramme: 12 months
Sitting time was assessed using International Physical Activity Questionnaire Short Form.
12 months
Change in Weight
Tidsramme: 12 months
12 months
Change in BMI
Tidsramme: 12 months
12 months
Change in Nutrition Knowledge
Tidsramme: 12 months
Questionnaire was used to assess knowledge of food sources of carbohydrates and dietary fiber
12 months
Change in Diabetes Treatment Satisfaction Score
Tidsramme: 12 months
Diabetes Treatment Satisfaction Questionnaire (Bradley,C) was used
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

United Arab Emirates University

Samarbejdspartnere

Ambulatory Healthcare Services, Al Ain, UAE
Sheikh Hamdan bin Rashid Al Maktoum Award for Medical Sciences

Efterforskere

  • Ledende efterforsker: Habiba I. Ali, PhD, RD,CDE, United Arab Emirates University

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 (Faktiske)

20. november 2011

Primær færdiggørelse (Faktiske)

28. november 2013

Studieafslutning (Faktiske)

24. december 2013

Datoer for studieregistrering

Først indsendt

8. februar 2020

Først indsendt, der opfyldte QC-kriterier

8. februar 2020

Først opslået (Faktiske)

11. februar 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. februar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. februar 2020

Sidst verificeret

1. februar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10/48

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes

Kliniske forsøg med Behavioral Lifestyle Intervention

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner