Live Your Life Without Diabetes
Primary Purpose
Pre Diabetes
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief theory-based health promotion intervention (group-based)
Sponsored by
About this trial
This is an interventional prevention trial for Pre Diabetes
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
Usual practice
Outcomes
Primary Outcome Measures
weight
change in weight / the proportion with weight reduction >5% of baseline weight at one-year
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
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
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
changes in physical activity.
Physical activity was measured using the International Physical Activity Questionnaire (IPAQ). Increased MET (min/week)=increased physical activity
Secondary Outcome Measures
patient activation
patient activation was measured using the Patient Activation Measure (PAM)
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.
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
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.
HbA1c
Blood tests were analysed in a central laboratory.
cholesterol
Total, LDL, HDL, Blood tests were analysed in a central laboratory.
Full Information
NCT ID
NCT03663803
First Posted
August 29, 2018
Last Updated
September 6, 2018
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT03663803
Brief Title
Live Your Life Without Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 19, 2011 (Actual)
Primary Completion Date
January 9, 2013 (Actual)
Study Completion Date
January 9, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual practice
Intervention Type
Behavioral
Intervention Name(s)
Brief theory-based health promotion intervention (group-based)
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight
Description
change in weight / the proportion with weight reduction >5% of baseline weight at one-year
Time Frame
baseline to one-year follow-up
Title
total-fat intake <30% of energy intake
Description
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
Title
saturated-fat intake <10% of energy intake
Description
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
Title
fibre-intake ≥15g/1000kcal changes in physical activity level.
Description
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
Title
changes in physical activity.
Description
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
Secondary Outcome Measure Information:
Title
patient activation
Description
patient activation was measured using the Patient Activation Measure (PAM)
Time Frame
change from baseline to one-year follow-up
Title
waist circumference
Description
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
Title
total energy intake
Description
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
Title
blood pressure, systolic and diastolic
Description
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
Title
HbA1c
Description
Blood tests were analysed in a central laboratory.
Time Frame
change from baseline to one-year follow-up
Title
cholesterol
Description
Total, LDL, HDL, Blood tests were analysed in a central laboratory.
Time Frame
change from baseline to one-year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
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Live Your Life Without Diabetes
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