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Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services

Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04245384
Acronym
DiOn
Enrollment
400
Registered
2020-01-28
Start date
2023-03-31
Completion date
2024-12-31
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

dietetics, telemedicine, dietitian

Brief summary

The project aims to investigate the effect of internet-based dietetic treatment (IDT) on patients, dietitians, and society. The project will show: * If IDT is equivalent to traditional dietetic treatment with physical meetings * Patients' attitudes to, and experiences of, meeting a dietician through video calls * How the dietician's work environment and working methods are affected by IDT * If there are subgroups of patients where IDT is more or less appropriate * Health economic and environmental consequences of IDT The major shortage of dietitians leaves patients with non-communicable diseases (NCD) without qualified dietary treatment. In a pilot study, the investigators have shown that IDT has great potential to streamline healthcare and increase accessibility. In the project Dietitian online, the investigators will conduct an RCT with 400 NCD-patients allocated to either IDT or standard dietetic treatment to see if IDT affect treatment outcome and whether IDT is appropriate for everyone. Even though internet-based treatment (IT) increases rapidly in society, there is little knowledge about the patients' experiences and how healthcare personnel incorporates IT in their daily work. The investigators will conduct qualitative studies to meet this knowledge gap. General assumptions are that IT is beneficial for society, both economically and environmentally, but very few studies have been done. The project will incorporate a full health-economic evaluation, including environmental impact.

Interventions

OTHERInternet-based dietetic treatment with video calls

The dietitian meets the patient through video calls, no physical meetings

OTHERTraditional dietetic treatment

The dietitian meets the patient through physical meetings

Sponsors

Västerbotten County Council, Sweden
CollaboratorOTHER_GOV
Forte
CollaboratorINDUSTRY
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* seeking/being referred to a dietitian for the treatment of obesity (BMI≥25) or obesity in combination with: * type 2 diabetes (HbA1c\>48mmol/mol) and/or * elevated blood lipids (total cholesterol \>4,5 mmol/l and/or LDL \>2,5 mmol/l and/or triglycerides \>2,0 mmol/l) and/or * high blood pressure (\>140/90 hg)

Exclusion criteria

* other diagnoses requiring/might require nutritional treatment (eg cancer, COPD) * dementia * severe impairment of sight, hearing, or other disability where internet-based dietetic treatment is deemed difficult * pregnancy * need for interpreter

Design outcomes

Primary

MeasureTime frameDescription
Change in dietary intakeChange from baseline to three, six and twelve months after first treatment sessionDietary intake will be assessed using the Swedish National Food Administrations Food Index (minimum value 0, maximum value 12, higher score indicates a healthier diet). Intake of fruit and vegetables in grams, as well as intake of discretionary calories (sweets, snacks, fast food, sugary drinks, pastries), will also be assessed.

Secondary

MeasureTime frameDescription
Change in participant alliance to dietitianChange from baseline to three and six months after first treatment sessionAlliance between patient and dietitian, measured with Working Alliance Inventory - Short (WAI-S, minimum value 12, maximum value 84, higher score indicates higher alliance to dietitian)
Change in participant activationChange from baseline to six months after first treatment sessionPatient activation (readiness to behavioral change), measured with Patient Activation Measure (PAM, (minimum value 0, maximum value 100, higher score indicates a higher activation (better)).
Change in participant motivationChange from baseline to three. six and twelve months after first treatment sessionPatient motivation (personal motivation to behavioral change), measured with VAS-scale 0-100, where higher score indicates higher motivation to behavioral change.

Other

MeasureTime frameDescription
Change in physical activityChange from baseline to three, six and twelve months after first treatment sessionPhysical activity, measured as average physical activity level (PAL) at work and at leisure time using a validated two-question questionnaire. PAL-levels from the questionnaire range between 1.4 - 2.3, where a higher score indicates higher physical activity
Change in health-related quality of lifeChange from baseline to six months after first treatment sessionHealth-related quality of life, measured with EQ-5D (minimum value 0, maximum value 1 where a higher value indicates higher quality of life
Change in body weightChange from baseline to three, six and twelve months after first treatment sessionSelf reported body weight

Contacts

Primary ContactPetra M Rydén, PhD
petra.ryden@umu.se+46907869557
Backup ContactSarah Persson, BSc
sarah.persson@umu.se+46907868069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026