An interventional study of Brief theory-based health promotion intervention (group-based) in Pre Diabetes, sponsored by University of Aarhus. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-10.
Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 127 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Brief theory-based health promotion intervention (group-based)
Usual practice
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.
weight
change in weight / the proportion with weight reduction \>5% of baseline weight at one-year
Time frame: baseline to one-year follow-up
total-fat intake <30% of energy intake
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
Time frame: change from baseline to one-year follow-up
saturated-fat intake <10% of energy intake
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
Time frame: change from baseline to one-year follow-up
fibre-intake ≥15g/1000kcal changes in physical activity level.
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
Time frame: change from baseline to one-year follow-up
changes in physical activity.
Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity
Time frame: change from baseline to one-year follow-up
patient activation
patient activation was measured using the Patient Activation Measure (PAM)
Time frame: change from baseline to one-year follow-up
waist circumference
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.
Time frame: change from baseline to one-year follow-up
total energy intake
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
Time frame: change from baseline to one-year follow-up
blood pressure, systolic and diastolic
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.
Time frame: change from baseline to one-year follow-up
HbA1c
Blood tests were analysed in a central laboratory.
Time frame: change from baseline to one-year follow-up
cholesterol
Total, LDL, HDL, Blood tests were analysed in a central laboratory.
Time frame: change from baseline to one-year follow-up
No study locations are listed for this record.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University of Aarhus