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

Study Overview
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Brief Summary
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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.

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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Other: Internet-based dietetic treatment with video calls
* Other: Traditional dietetic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based treatment<br>Internet-based dietetic treatment with video calls, no physical meetings | Other: Internet-based dietetic treatment with video calls<br>* The dietitian meets the patient through video calls, no physical meetings<br>|
| Active Comparator: Standard treatment<br>Dietetic treatment with physical meetings | Other: Traditional dietetic treatment<br>* The dietitian meets the patient through physical meetings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant alliance to dietitian | 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 from baseline to three and six months after first treatment session | 
| Change in participant activation | 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)). | Change from baseline to six months after first treatment session | 
| Change in participant motivation | Patient motivation (personal motivation to behavioral change), measured with VAS-scale 0-100, where higher score indicates higher motivation to behavioral change. | Change from baseline to three. six and twelve months after first treatment session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietetics, telemedicine, dietitian