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

Not Applicable

Not yet recruiting

• Conditions: Overweight and Obesity
• Interventions: Other: Internet-based dietetic treatment with video calls; Other: Traditional dietetic treatment

• Registration Number: NCT04245384
• Lead Sponsor: Umeå University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-04
• Study Start: 2023-03
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based treatment	Internet-based dietetic treatment with video calls	Internet-based dietetic treatment with video calls, no physical meetings
Standard treatment	Traditional dietetic treatment	Dietetic treatment with physical meetings

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)
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)).