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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
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring dietetics, telemedicine, dietitian

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 21, 2020
    Last Updated
    November 3, 2022
    Sponsor
    Umeå University
    Collaborators
    Västerbotten County Council, Sweden, Forte
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    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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