Overweight and ObesityDiOnNCT04245384
Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
A study testing Internet-based dietetic treatment with video calls and Traditional dietetic treatment in people with Overweight and Obesity, run by Umeå University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Internet-based dietetic treatment with video calls and Traditional dietetic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Overweight and Obesity
- Being tested
- Internet-based dietetic treatment with video calls, Traditional dietetic treatment
- Keywords
- dietetics, telemedicine, dietitian
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based dietetic treatment with video callsOther
The dietitian meets the patient through video calls, no physical meetings
Traditional dietetic treatmentOther
The dietitian meets the patient through physical meetings
| Study group | Role | What they receive |
|---|---|---|
| Internet-based treatment | Experimental | Internet-based dietetic treatment with video calls, no physical meetings Receives: Other: Internet-based dietetic treatment with video calls |
| Standard treatment | Active comparator | Dietetic treatment with physical meetings Receives: Other: Traditional dietetic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to three, six and twelve months after first treatment session
Secondary outcomes (3)
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)
Measured: 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)).
Measured: 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.
Measured: Change from baseline to three. six and twelve months after first treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study startMar 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Västerbotten County Council, Sweden, Forte
- Responsible party
- Sponsor
- Investigators
- Petra M Rydén, PhD, Principal investigator, Umea university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245384
- Sponsor's protocol ID
- UmUDiOn
- Acronym
- DiOn
- Status last verified
- Nov 2022
- First submitted
- 21 Jan 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietitian Online - Internet-based Dietetic Treatment Within Health Care Services
- ClinicalTrials.gov ID
- NCT04245384
- Acronym / sponsor ID
- DiOn / UmUDiOn
- Conditions
- Overweight and Obesity
- Keywords
- dietetics, telemedicine, dietitian
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Västerbotten County Council, Sweden, Forte
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based treatment | Experimental | Other: Internet-based dietetic treatment with video callsInternet-based dietetic treatment with video calls, no physical meetings |
| Standard treatment | Active comparator | Other: Traditional dietetic treatmentDietetic treatment with physical meetings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- seeking/being referred to a dietitian for the treatment of obesity (BMI≥25) or obesity in combination with:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based dietetic treatment with video callsThe dietitian meets the patient through video calls, no physical meetings | Other | Internet-based treatment |
| Traditional dietetic treatmentThe dietitian meets the patient through physical meetings | Other | Standard treatment |
Primary outcome
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.
3 secondary outcomes
Change in participant alliance to dietitian
Time frame: Change from baseline to three and six months after first treatment session
Change in participant activation
Time frame: Change from baseline to six months after first treatment session
Change in participant motivation
Time frame: Change from baseline to three. six and twelve months after first treatment session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Official website for the project (only in Swedish)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Overweight and Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra M Rydén, PhD principal investigator
Umea university
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based dietetic treatment with video calls and Traditional dietetic treatment in people with Overweight and Obesity, run by Umeå University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petra M Rydén, PhD (+46907869557, petra.ryden@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dietary intake (time frame: Change from baseline to three, six and twelve months after first treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.