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

Sponsor
Umeå University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04245384
Collaborator
Västerbotten County Council, Sweden (Other), Forte (Industry)
400
2
26

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Internet-based dietetic treatment with video calls
  • Other: Traditional dietetic treatment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in dietary intake [Change from baseline to three, six and twelve months after first treatment session]

    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

  1. Change in participant alliance to dietitian [Change from baseline to three and six months after first treatment session]

    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)

  2. Change in participant activation [Change from baseline to six months after first treatment session]

    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)).

  3. Change in participant motivation [Change from baseline to three. six and twelve months after first treatment session]

    Patient motivation (personal motivation to behavioral change), measured with VAS-scale 0-100, where higher score indicates higher motivation to behavioral change.

Other Outcome Measures

  1. Change in body weight [Change from baseline to three, six and twelve months after first treatment session]

    Self reported body weight

  2. Change in physical activity [Change from baseline to three, six and twelve months after first treatment session]

    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

  3. Change in health-related quality of life [Change from baseline to six months after first treatment session]

    Health-related quality of life, measured with EQ-5D (minimum value 0, maximum value 1 where a higher value indicates higher quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Umeå University
  • Västerbotten County Council, Sweden
  • Forte

Investigators

  • Principal Investigator: Petra M Rydén, PhD, Umea university

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Umeå University
ClinicalTrials.gov Identifier:
NCT04245384
Other Study ID Numbers:
  • UmUDiOn
First Posted:
Jan 28, 2020
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Umeå University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2021