Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT07258758
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Intervention Involving Person-centred Nutritional Education
Sponsor:
Umeå University
Organization:
Study Overview
Official Title:
Diabetes Intervention Involving Person-centred Nutritional Education (DINE) - Exploring the Benefits and Challenges of a Person-centred Education on the Nordic Diet for Adults With Type 1 Diabetes.
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DINE
Brief Summary:
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 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: