Effect of Structured Nutrition Education in Type 1 Diabetes

Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes

Sponsors

Lead Sponsor: Göteborg University

Source Göteborg University
Brief 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.

Overall Status Completed
Start Date February 2013
Completion Date July 2017
Primary Completion Date December 2014
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
HbA1c 1 year
Secondary Outcome
Measure Time Frame
Quality of life 1 year
CVD risk factors 1 year
Hypoglycemia 1 year
Food choices 1 year
Health economics 1 year
Enrollment 181
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Structured education in carbohydrate counting

Arm Group Label: Structured education in carbohydrate counting

Intervention Type: Behavioral

Intervention Name: Structured education in healthy food choices and low glycemic index

Arm Group Label: Structured education in healthy food choices and low GI

Eligibility

Criteria:

Inclusion Criteria:

- Having type 1 diabetes

- Diabetes duration > 3 years

- Age 20-70 years

- BMI <35 (kg/m2)

- Multiple dose injection (MDI) therapy

- HbA1c 57-78 mmol/mol

- Being healthy other than diabetes

- Autonomous accommodation and having influence over one's own food choices.

- Have given informed consent to participate in the study, as well as having the ability of oral and written communication in Swedish.

Exclusion Criteria:

- Nephropathy (dU albumin> 300 mg / d)

- Retinopathy (grade> 2)

- Foot ulcers

- Gastroparesis

- Difficulties visiting the hospital

- Current or planned pregnancy during the study period

- ≥ 14 days fast during the study period

- Having partaken in education in carbohydrate counting (≥ 4 hours) in the last two years

- No computer access

Gender: All

Minimum Age: 20 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mette Axelsen, PhD Principal Investigator Göteborg University
Verification Date

November 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Structured education in carbohydrate counting

Type: Experimental

Description: A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)

Label: Structured education in healthy food choices and low GI

Type: Experimental

Description: 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.

Label: Regular routine

Type: No Intervention

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov