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

Overweight and Obesity Clinical Trial

— DiOn  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04245384
• Other study ID #: UmUDiOn
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Umeå University
• Contact: Petra M Rydén, PhD
• Phone: +46907869557
• Email: petra.ryden[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Other:
• Internet-based dietetic treatment with video calls
The dietitian meets the patient through video calls, no physical meetings
• Traditional dietetic treatment
The dietitian meets the patient through physical meetings

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	Forte, Västerbotten County Council, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body weight	Self reported body weight	Change from baseline to three, six and twelve months after first treatment session
Other	Change in physical activity	Physical 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 from baseline to three, six and twelve months after first treatment session
Other	Change in health-related quality of life	Health-related quality of life, measured with EQ-5D (minimum value 0, maximum value 1 where a higher value indicates higher quality of life	Change from baseline to six months after first treatment session
Primary	Change in dietary intake	Dietary 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.	Change from baseline to three, six and twelve months after first treatment session
Secondary	Change in participant alliance to dietitian	Alliance 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 from baseline to three and six months after first treatment session
Secondary	Change in participant activation	Patient 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 from baseline to six months after first treatment session
Secondary	Change in participant motivation	Patient motivation (personal motivation to behavioral change), measured with VAS-scale 0-100, where higher score indicates higher motivation to behavioral change.	Change from baseline to three. six and twelve months after first treatment session

External Links

•   Official website for the project (only in Swedish)