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Live Your Life Without Diabetes

6 september 2018 bijgewerkt door: University of Aarhus

Effectiveness of a Brief Theory-based Health Promotion Intervention Among Adults at High Risk of Type 2 Diabetes: One-year Results From a Randomised Trial in a Community Setting

Aim: To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes.

Methods: A randomised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose: 6.1-6.9 mmol/l and/or HbA1c : 6.0-<6.5% (42- < 48 mmol/mol) recruited from general practice in Holstebro, Denmark. Participants were randomised to a control group or to receive the intervention delivered over four 2 h group sessions during five weeks, and two further sessions after one and six months. Questionnaire data and clinical measures were collected at baseline, three months and one year after intervention.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

127

Fase

  • Niet toepasbaar

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

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • resident in the Municipality of Holstebro
  • aged <70 years
  • a measurement of fasting plasma glucose: 6.1-6.9 mmol/l (the thresholds for Impaired Fasting Glucose according to clinical guidelines) and/or HbA1c : 6.0-<6.5% (42- <48 mmol/mol) within the previous six months.

Exclusion Criteria:

  • none

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: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention
Participants in the intervention group received the offer of four 2h group sessions during five weeks, and two further sessions after one and six months. The attendance rates of the sessions were 95%, 88%, 87%, 73%, 67% and 51%, respectively. The course was delivered by health care staff in the Holstebro Health Care Centre, including a dietitian and an occupational therapist, both with health pedagogic competences. It was delivered to seven intervention groups, which varied in size from 5 to 15 participants.
Gedragsmatig: Brief theory-based health promotion intervention (group-based)
The intervention is depicted using a PaT Plot in the published paper: Juul, L et al. Effectiveness of a brief theory-based health promotion intervention among adults at high risk of type 2 diabetes: One-year results from a randomised trial in a community setting. Primary Care Diabetes 1 0 ( 2 0 1 6 ) 111-120.
Geen tussenkomst: Control
Usual practice

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
weight
Tijdsspanne: baseline to one-year follow-up
change in weight / the proportion with weight reduction >5% of baseline weight at one-year
baseline to one-year follow-up
total-fat intake <30% of energy intake
Tijdsspanne: change from baseline to one-year follow-up
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ. Portion size was set according to gender. Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
change from baseline to one-year follow-up
saturated-fat intake <10% of energy intake
Tijdsspanne: change from baseline to one-year follow-up
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ. Portion size was set according to gender. Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
change from baseline to one-year follow-up
fibre-intake ≥15g/1000kcal changes in physical activity level.
Tijdsspanne: change from baseline to one-year follow-up
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ. Portion size was set according to gender. Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
change from baseline to one-year follow-up
changes in physical activity.
Tijdsspanne: change from baseline to one-year follow-up
Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity
change from baseline to one-year follow-up

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
patient activation
Tijdsspanne: change from baseline to one-year follow-up
patient activation was measured using the Patient Activation Measure (PAM)
change from baseline to one-year follow-up
waist circumference
Tijdsspanne: change from baseline to one-year follow-up
Waist circumference was recorded as the average of two measurements of waist circumference using a tape measure halfway between the lowest point of the rib cage and the anterior supe- rior iliac crests when standing.
change from baseline to one-year follow-up
total energy intake
Tijdsspanne: change from baseline to one-year follow-up
Information on diet was obtained using a validated self-administrated 198-item food frequency questionnaire (FFQ), the Inter99 FFQ. Portion size was set according to gender. Daily nutrient intake was translated into energy intake and nutrient intake using the Danish Food Com- position Databank (version 7.01) and the software program FoodCalc version 1.3
change from baseline to one-year follow-up
blood pressure, systolic and diastolic
Tijdsspanne: change from baseline to one-year follow-up
Systolic and diastolic blood pressure was calculated as the mean of three measurements performed after at least 10 min rest, while participants were seated with the cuff on the right arm at the level of the heart.
change from baseline to one-year follow-up
HbA1c
Tijdsspanne: change from baseline to one-year follow-up
Blood tests were analysed in a central laboratory.
change from baseline to one-year follow-up
cholesterol
Tijdsspanne: change from baseline to one-year follow-up
Total, LDL, HDL, Blood tests were analysed in a central laboratory.
change from baseline to one-year follow-up

Medewerkers en onderzoekers

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

Sponsor

University of Aarhus

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 (Werkelijk)

19 januari 2011

Primaire voltooiing (Werkelijk)

9 januari 2013

Studie voltooiing (Werkelijk)

9 januari 2013

Studieregistratiedata

Eerst ingediend

29 augustus 2018

Eerst ingediend dat voldeed aan de QC-criteria

6 september 2018

Eerst geplaatst (Werkelijk)

10 september 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2018

Laatste update ingediend die voldeed aan QC-criteria

6 september 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2018-02-3065

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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