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Clinical Trials/NCT04245384
NCT04245384Not yet recruitingNot Applicable

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

Umeå University0 sites400 target enrollmentStarted: March 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
400
Primary Endpoint
Change in dietary intake

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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)
  • severe impairment of sight, hearing, or other disability where internet-based dietetic treatment is deemed difficult
  • pregnancy
  • need for interpreter

Outcomes

Primary Outcomes

Change in dietary intake

Time Frame: 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 Outcomes

  • Change in participant motivation(Change from baseline to three. six and twelve months after first treatment session)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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