Effect of Structured Nutrition Education in Type 1 Diabetes
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Structured education in carbohydrate counting
Structured education in healthy food choices and low glycemic index
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Structured education in carbohydrate counting
Structured education in healthy food choices and low GI
Regular routine
Arm Description
A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
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.
Outcomes
Primary Outcome Measures
HbA1c
The primary outcome measure is to detect a clinically significant difference in HbA1c (= 4.2 mmol / mol) between the three treatment arms
Secondary Outcome Measures
Quality of life
Secondary measures is to demonstrate a difference between the groups in terms of quality of life
CVD risk factors
Secondary measures is to demonstrate a difference between the groups in terms of CVD risk factors
Hypoglycemia
Secondary objectives is to demonstrate a difference between the groups in terms of hypoglycemia
Food choices
To demonstrate a difference between the groups in terms of food choices
Health economics
A secondary objective is to demonstrate a difference between the groups in terms of health economics and compare cost- effectiveness of the treatment arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01791907
Brief Title
Effect of Structured Nutrition Education in Type 1 Diabetes
Official Title
Effect of Structured Education in Advanced Carbohydrate Counting or Healthy Food Choices With Low Glycemic Index in Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
4. Oversight
5. Study Description
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:
A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Structured education in carbohydrate counting
Arm Type
Experimental
Arm Description
A structured education in carbohydrate counting, a course inspired by the DAFNE program (Dose Adjustment For Normal Eating)
Arm Title
Structured education in healthy food choices and low GI
Arm Type
Experimental
Arm 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.
Arm Title
Regular routine
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Structured education in carbohydrate counting
Intervention Type
Behavioral
Intervention Name(s)
Structured education in healthy food choices and low glycemic index
Primary Outcome Measure Information:
Title
HbA1c
Description
The primary outcome measure is to detect a clinically significant difference in HbA1c (= 4.2 mmol / mol) between the three treatment arms
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life
Description
Secondary measures is to demonstrate a difference between the groups in terms of quality of life
Time Frame
1 year
Title
CVD risk factors
Description
Secondary measures is to demonstrate a difference between the groups in terms of CVD risk factors
Time Frame
1 year
Title
Hypoglycemia
Description
Secondary objectives is to demonstrate a difference between the groups in terms of hypoglycemia
Time Frame
1 year
Title
Food choices
Description
To demonstrate a difference between the groups in terms of food choices
Time Frame
1 year
Title
Health economics
Description
A secondary objective is to demonstrate a difference between the groups in terms of health economics and compare cost- effectiveness of the treatment arms
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Axelsen, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effect of Structured Nutrition Education in Type 1 Diabetes
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