Live Your Life Without Diabetes

Pre Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663803
• Other study ID #: 2018-02-3065
• Status: Completed
• Phase: N/A
• Start date: January 19, 2011
• Est. completion date: January 9, 2013

Study information

• Verified date: August 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 9, 2013
• Est. primary completion date: January 9, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre Diabetes
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	change in weight / the proportion with weight reduction >5% of baseline weight at one-year	baseline to one-year follow-up
Primary	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	change from baseline to one-year follow-up
Primary	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	change from baseline to one-year follow-up
Primary	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	change from baseline to one-year follow-up
Primary	changes in physical activity.	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
Secondary	patient activation	patient activation was measured using the Patient Activation Measure (PAM)	change from baseline to one-year follow-up
Secondary	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.	change from baseline to one-year follow-up
Secondary	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	change from baseline to one-year follow-up
Secondary	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.	change from baseline to one-year follow-up
Secondary	HbA1c	Blood tests were analysed in a central laboratory.	change from baseline to one-year follow-up
Secondary	cholesterol	Total, LDL, HDL, Blood tests were analysed in a central laboratory.	change from baseline to one-year follow-up