Diabetes Intervention Involving Person-centred Nutritional Education
NCT ID: NCT07258758
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54 participants
INTERVENTIONAL
2025-09-01
2027-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Person-centred nutritional education
The participants in this arm will attend a person-centred intervention involving a pre-assessment focused on creating partnership in care. This is followed by a nutrition education session on the healthy Nordic diet, and a series of follow-up measures.
Dietary intervention
A person-centred education focussed on creating partnerships in care and shared decision-making.
Short dietary information
The participants in this arm will receive short dietary information (brochure) at the same level as standard care.
No interventions assigned to this group
Interventions
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Dietary intervention
A person-centred education focussed on creating partnerships in care and shared decision-making.
Eligibility Criteria
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Inclusion Criteria
* Diabetes duration for more than 12 months at screening.
* Adults 18 years or older.
* HbA1c more than 57mmol/mol.
* Use of continuous glucose monitoring (CGM) sensor for more than three months at screening and during the study period.
* Use of basal and bolus insulin regimen for more than three months at screening and during the study period.
* Written Informed Consent.
Exclusion Criteria
* Cognitive impairment or other disease that study physician find non-compatible with participation.
* Planned change in glucose lowering treatment during study period (change of mealtime insulin analogue with same pharmacodynamic profile allowed).
* Planned change of CGM sensor during the study.
* Food allergies or intolerances that are incompatible with adhering to Nordic nutrition recommendations.
* Current or planned treatment with corticosteroids during the study (other than for replacement therapy).
18 Years
ALL
No
Sponsors
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Lasarettet i Enköping
OTHER
Umeå University
OTHER
Responsible Party
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Elisabeth Stoltz Sjöström
Associate Professor
Principal Investigators
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Elisabeth Stoltz Sjöström, Associate professor
Role: PRINCIPAL_INVESTIGATOR
Department of Food, Nutrition and Culinary Science, Umeå University, Sweden
Locations
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Hospital of Enköping
Enköping, Uppland, Sweden
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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2024-04356-01
Identifier Type: -
Identifier Source: org_study_id
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