The InnvaDiab-DE-PLAN study: a randomised controlled trial with a culturally adapted education programme improved the risk profile for type 2 diabetes in Pakistani immigrant women

The objective of the present study was to explore whether a culturally adapted lifestyle education programme would improve the risk factor profile for type 2 diabetes (T2D) and the metabolic syndrome (MetS) among Pakistani immigrant women in Oslo, Norway. The randomised controlled trial (the InnvaDiab study), lasting 7 ± 1 months, comprised six educational sessions about blood glucose, physical activity and diet. Participants (age 25-62 years) were randomised into either a control (n 97) or an intervention (n 101) group. Primary outcome variables were fasting and 2 h blood glucose, and secondary outcome variables were fasting levels of insulin, C-peptide, lipids, glycated Hb, BMI, waist circumference and blood pressure, measured 1-3 weeks before and after the intervention. During the intervention period, the mean fasting blood glucose decreased by 0·16 (95 % CI -0·27, -0·05) mmol/l in the intervention group, and remained unchanged in the control group (difference between the groups, P=0·022). Glucose concentration 2 h after the oral glucose tolerance test decreased by 0·53 (95 % CI -0·84, -0·21) mmol/l in the intervention group, but not significantly more than in the control group. A larger reduction in fasting insulin was observed in the intervention group than in the control group (between-group difference, P= 0·036). Among the individuals who attended four or more of the educational sessions (n 59), we found a more pronounced decrease in serum TAG (-0·1 (95 % CI -0·24, 0·07) mmol/l) and BMI (-0·48 (95 % CI -0·78, -0·18) kg/m²) compared with the control group. During the intervention period, there was a significant increase in participants having the MetS in the control group (from 41 to 57 %), which was not seen in the intervention group (from 44 to 42 %). Participation in a culturally adapted education programme may improve risk factors for T2D and prevent the development of the MetS in Pakistani immigrant women.