NCT04245384

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
3.1 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

January 21, 2020

Last Update Submit

November 3, 2022

Conditions

Keywords

dieteticstelemedicinedietitian

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in participant alliance to dietitian

    Change from baseline to three and six months after first treatment session

  • Change in participant activation

    Change from baseline to six months after first treatment session

  • Change in participant motivation

    Change from baseline to three. six and twelve months after first treatment session

Other Outcomes (3)

  • Change in body weight

    Change from baseline to three, six and twelve months after first treatment session

  • Change in physical activity

    Change from baseline to three, six and twelve months after first treatment session

  • Change in health-related quality of life

    Change from baseline to six months after first treatment session

Study Arms (2)

Internet-based treatment

EXPERIMENTAL

Internet-based dietetic treatment with video calls, no physical meetings

Other: Internet-based dietetic treatment with video calls

Standard treatment

ACTIVE COMPARATOR

Dietetic treatment with physical meetings

Other: Traditional dietetic treatment

Interventions

The dietitian meets the patient through video calls, no physical meetings

Internet-based treatment

The dietitian meets the patient through physical meetings

Standard treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Petra M Rydén, PhD

    Umea university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra M Rydén, PhD

CONTACT

Sarah Persson, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

March 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 4, 2022

Record last verified: 2022-11