Clinical trial NCT04245384: Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
Official title: Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Keywords: dietetics
telemedicine
dietitian
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Västerbotten County Council, Sweden
name: Forte
First posted: 2020-01-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in dietary intake
timeFrame: Change from baseline to three, six and twelve months after first treatment session
Secondary outcomes:
measure: Change in participant alliance to dietitian
timeFrame: Change from baseline to three and six months after first treatment session
measure: Change in participant activation
timeFrame: Change from baseline to six months after first treatment session
measure: Change in participant motivation
timeFrame: Change from baseline to three. six and twelve months after first treatment session
Other outcomes:
measure: Change in body weight
timeFrame: Change from baseline to three, six and twelve months after first treatment session
measure: Change in physical activity
timeFrame: Change from baseline to three, six and twelve months after first treatment session
measure: Change in health-related quality of life
timeFrame: Change from baseline to six months after first treatment session
Locations:
Study officials:
affiliation: Umea university
name: Petra M Rydén, PhD
role: PRINCIPAL_INVESTIGATOR
References: