Effect of Structured Nutrition Education in Type 1 Diabetes

NCT ID: NCT01791907

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-07-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Structured education in carbohydrate counting

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

Group Type: EXPERIMENTAL

Structured education in carbohydrate counting

Intervention Type: BEHAVIORAL

Structured education in healthy food choices and low GI

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.

Group Type: EXPERIMENTAL

Structured education in healthy food choices and low glycemic index

Intervention Type: BEHAVIORAL

Regular routine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Structured education in carbohydrate counting

Intervention Type: BEHAVIORAL

Structured education in healthy food choices and low glycemic index

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mette Axelsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Other Identifiers

EPN 304-12

Identifier Type: -

Identifier Source: org_study_id