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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
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 7, 2013
    Last Updated
    November 1, 2018
    Sponsor
    Göteborg University
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    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

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