Effect of Structured Nutrition Education in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 diabetes (T1DM) is a chronic disease that affects approximately 10% of all diabetes
      patients in the world. Diabetes a serious disease in which life expectancy is reduced,
      largely due to increased mortality from kidney disease and cardiovascular (CVD) disease. Poor
      glycemic control also results in eye and nerve damage, and psychosocial stress. Good
      metabolic control, e.g. normalized hemoglobin levels (HbA1c) and normal blood lipids, reduces
      the risk of eye, kidney, nerve, and vascular damage. Proper nutrition can normalize blood
      sugar levels, improve blood lipids and prolong life in people with diabetes, according to
      Swedish Council on Health Technology Assessment (SBU).

      Dietary treatment is therefore seen as pivotal in the treatment of diabetes. This project
      aims to evaluate two methods of structured training in patients with type 1 diabetes:

        1. A structured education in carbohydrate counting, a course inspired by the DAFNE program
           (Dose Adjustment For Normal Eating)

        2. A new, structured education for heart healthy food choices and low glycemic index in
           type 1 diabetes. The education is called "My Wellness-LADDER" (Lifelong Adult Diet &
           Diabetes Education Resource) and it is specifically designed to provide high long-term
           adherence through improved empowerment and transformative life style change.

      The methods are compared with regular routine (control group).

      This is a randomized controlled trial with three intervention groups 1) Healthy food choices
      with a low glycemic index, 2) carbohydrate counting, and 3) regular routine. Follow-up period
      is 1 year. Eight Swedish specialist clinics are participating and 24 patients at each clinic
      are to be enrolled.

      The hypotheses is that structured group education on heart healthy food choices and low
      glycemic index provide the same improvement in glycemic control and quality of life as
      advanced carbohydrate counting in T1DM, as compared to regular routine. An additional
      hypotheses is that structured education on healthy food choices and low glycemic index leads
      to larger CVD risk factor reductions in T1DM compared to carbohydrate counting and regular
      routine and that structured education on healthy food choices and low glycemic index lead to
      more heart healthy food choices in T1DM compared to carbohydrate counting and regular
      routine. Lastly, the hypotheses is that structured education on healthy food choices and low
      glycemic index lead is more cost effective in T1DM compared to carbohydrate counting and
      regular routine.
    


Intervention name(s): Structured education in carbohydrate counting; Structured education in healthy food choices and low glycemic index
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment