Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services (DiOn)
Primary Purpose
Overweight and Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-based dietetic treatment with video calls
Traditional dietetic treatment
Sponsored by

About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring dietetics, telemedicine, dietitian
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Internet-based treatment
Standard treatment
Arm Description
Internet-based dietetic treatment with video calls, no physical meetings
Dietetic treatment with physical meetings
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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 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.
Full Information
NCT ID
NCT04245384
First Posted
January 21, 2020
Last Updated
November 3, 2022
Sponsor
Umeå University
Collaborators
Västerbotten County Council, Sweden, Forte
1. Study Identification
Unique Protocol Identification Number
NCT04245384
Brief Title
Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
Acronym
DiOn
Official Title
Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Umeå University
Collaborators
Västerbotten County Council, Sweden, Forte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
dietetics, telemedicine, dietitian
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-based treatment
Arm Type
Experimental
Arm Description
Internet-based dietetic treatment with video calls, no physical meetings
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Dietetic treatment with physical meetings
Intervention Type
Other
Intervention Name(s)
Internet-based dietetic treatment with video calls
Intervention Description
The dietitian meets the patient through video calls, no physical meetings
Intervention Type
Other
Intervention Name(s)
Traditional dietetic treatment
Intervention Description
The dietitian meets the patient through physical meetings
Primary Outcome Measure Information:
Title
Change in dietary intake
Description
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.
Time Frame
Change from baseline to three, six and twelve months after first treatment session
Secondary Outcome Measure Information:
Title
Change in participant alliance to dietitian
Description
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)
Time Frame
Change from baseline to three and six months after first treatment session
Title
Change in participant activation
Description
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)).
Time Frame
Change from baseline to six months after first treatment session
Title
Change in participant motivation
Description
Patient motivation (personal motivation to behavioral change), measured with VAS-scale 0-100, where higher score indicates higher motivation to behavioral change.
Time Frame
Change from baseline to three. six and twelve months after first treatment session
Other Pre-specified Outcome Measures:
Title
Change in body weight
Description
Self reported body weight
Time Frame
Change from baseline to three, six and twelve months after first treatment session
Title
Change in physical activity
Description
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
Time Frame
Change from baseline to three, six and twelve months after first treatment session
Title
Change in health-related quality of life
Description
Health-related quality of life, measured with EQ-5D (minimum value 0, maximum value 1 where a higher value indicates higher quality of life
Time Frame
Change from baseline to six months after first treatment session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Petra M Rydén, PhD
Phone
+46907869557
Email
petra.ryden@umu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Persson, BSc
Phone
+46907868069
Email
sarah.persson@umu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petra M Rydén, PhD
Organizational Affiliation
Umea university
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.umu.se/dion
Description
Official website for the project (only in Swedish)
Learn more about this trial
Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
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