Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services (DiOn)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Other: Internet-based dietetic treatment with video calls; Other: Traditional dietetic treatment

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petra M Rydén, PhD; Phone Number: +46907869557; Email: petra.ryden@umu.se
• Study Contact Backup: Name: Sarah Persson, BSc; Phone Number: +46907868069; Email: sarah.persson@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Internet-based treatment; Internet-based dietetic treatment with video calls, no physical meetings	Other: Internet-based dietetic treatment with video calls; The dietitian meets the patient through video calls, no physical meetings
ACTIVE_COMPARATOR: Standard treatment; Dietetic treatment with physical meetings	Other: Traditional dietetic treatment; The dietitian meets the patient through physical meetings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Self reported body weight	Change from baseline to three, six and twelve months after first treatment session
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
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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Forte; Västerbotten County Council, Sweden
• Investigators: Principal Investigator: Petra M Rydén, PhD, Umeå University

Publications and helpful links

Helpful Links

• Official website for the project (only in Swedish)

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: telemedicine; dietitian; dietetics
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: UmUDiOn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No