The overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. The study will measure the intervention's impact on blood glucose levels, blood lipids, blood pressure, and adherence to a sustainable and healthy Nordic diet. The main question the trial aims to answer is: Does a person-centred nutritional education have an impact on glucose time in range for adults with Type 1 diabetes, compared with short dietary information? The participants will: * Attend either a person-centred nutrition education (intervention) or receive short dietary information (control group). * Wear their sensor for continuous glucose monitoring (CGM) throughout the trial. * Visit the clinic for data collection (blood samples and clinical checks) at the start and end of the trial. * Keep a four-day food diary, fill out a food frequency questionnaire (FFQ) and estimate their food enjoyment at the start and end of the trial.
The Diabetes Intervention Involving Person-centred Nutritional Education (DINE) trial is a single-centre, randomized parallel group study conducted in Sweden. The trial aims to compare a person-centred intervention involving nutritional education with the current practice of providing short dietary information to adults with Type 1 diabetes. The study period is six months and will assess the effectiveness of the intervention in a real-world setting, rather than under controlled conditions. Due to the active involvement of participants, blinding of study personnel or participants is not possible. To determine the sample size, a power calculation was performed using the primary endpoint, 'blood glucose time in range' (TIR). The calculation is based on a clinically relevant change in TIR (8%) from intervention to the six-month follow-up. The proposed enrolment is 54 participants to achieve sufficient power (80%) to test the primary hypothesis. Recruitment will continue until this number is reached. Assuming an 80% consent rate, we expect to enrol at least 54 participants within 12 months. Participants in the intervention group will start with an individual pre-assessment with a registered dietitian, focusing on their preferences and values. This aims to build a partnership in care through the participant´s narrative. Next, they will attend an education session on the sustainable, healthy Nordic diet. During this session, the participant will develop an individual health plan together with the dietitian as part of shared decision-making. These handwritten plans will be copied, with one given to the participant and one kept by the dietitian for medical records. The health plans will be reviewed twice during the study period, allowing for updates with new goals or more realistic targets. These updates will be documented by the dietitian. Participants will receive monthly text message reminders to enhance the intervention's efficacy. Control group participants will receive short dietary information as part of routine clinical practice. The study duration for all participants is six months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
A person-centred education focussed on creating partnerships in care and shared decision-making.
Hospital of Enköping
Enköping, Uppland, Sweden
RECRUITINGTime in range - Percentage of time spent with blood glucose levels between 3.9-10 mmol/l.
Percentage of time spent with glucose levels between 3.9-10 mmol/l measured with continuous glucose monitor (CGM) over 10-14 days.
Time frame: Week 1, 12 and 24.
Adherence to a Nordic diet.
Evaluation and analysis of diet data from Food frequency questionnaire (FFQ) and food diary.
Time frame: Week 1 and 24.
Glycosylated Hemoglobin (HbA1c).
HbA1c represents overall glycaemic control over the last three months.
Time frame: Week 1 and 24.
Time above range - percentage of time spent with blood glucose levels above 10.0 mmol/L and 13.9 mmol/L respectively.
Percentage of time with high blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Time frame: Week 1, 12 and 24.
Time below range - percentage of time spent with blood glucose levels below 3.9 mmol/L and 3.0 mmol/L respectively.
Percentage of time with low blood glucose levels, measured with continuous glucose monitor over 10-14 days.
Time frame: Week 1, 12 and 24.
Blood lipids.
Blood lipids (total cholesterol, high-density cholesterol, low-density cholesterol, triglycerides, non-HDL cholesterol, cholesterol/HDL ratio) assessed in a clinical laboratory.
Time frame: Week 1 and 24.
Blood pressure.
Systolic and diastolic blood pressure measured at hospital clinic.
Time frame: Week 1 and 24.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.