Occupational DiseasesNCT06923735
Nutrition Apps in Occupational Healthcare (Pilot Study of the FOODNUTRI Project)
A study testing Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition Path in people with Occupational Diseases and Overweight and Obesity, run by University of Eastern Finland at 1 site in Finland.
Trial summary
The aim of this study is to investigate (1) the user experiences and usability of the nutrition apps (the Finnish Nutrition Navigator and the Finnish Nutrition Path) in occupational health care from the perspective of both professionals and customers, (2) the impact on diet, eating behavior, perceived well-being… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Diseases, Overweight and Obesity, Dyslipidemias
- What is being tested?
- Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition Path
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteFinland
- Study dates
- 11 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee of the certain employer
- Coming to the medical examination for employees whose work presents a special risk of illnessa OR coming to the dietitian because of dyslipidemia, high blood pressure, weight loss, weight management, type 2 diabetes, cardiovascular disease
- Understands written Finnish
Who cannot join
- Pregnancy
- Eating disorder
- Severe challenges with diet (e.g., malabsorption, very restrictive diet due to several food allergies or other reasons)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to investigate (1) the user experiences and usability of the nutrition apps (the Finnish Nutrition Navigator and the Finnish Nutrition Path) in occupational health care from the perspective of both professionals and customers, (2) the impact on diet, eating behavior, perceived well-being (perceived state of health, quality of life, work and functional ability) and anthropometric indicators compared to treatment as usual, and (3) cost-effectiveness of using the nutrition apps.
Read the detailed description
For the occupational healthcare customer, the study will include two visits to the occupational healthcare: at baseline and after a 12-week follow-up. First, all volunteer participants enrolled in the study will belong to the control group and they will get the treatment as usual. Their weight, waist circumference, and blood pressure are measured at the visit and they are asked to answer a digital research questionnaire at both baseline and follow-up.
The rest of the volunteer participants enrolled in the study will belong to the intervention group. Before the visit at the occupational healthcare, they are asked to fill in the Finnish Nutrition Navigator and to read the automated feedback about the diet quality. The Finnish Nutrition Path can help in the dietary goal setting and it can be utilized together with the professional or independently. In addition, also weight, waist circumference, and blood pressure are measured at the visit and the participant is asked to answer a digital research questionnaire. The same procedure is done at both baseline and follow-up.
- Conditions
- Occupational Diseases, Overweight and Obesity, Dyslipidemias, Hypertension, Diabete Type 2, Cardiovascular Diseases
- Being tested
- Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition Path
- Medical subject headings
- Occupational Diseases, Overweight, Obesity, Dyslipidemias, Hypertension, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition PathOther
Participant fills in the food intake questionnaire of the Finnish Nutrition Navigator and receives an automated feedback on the diet before the visit to the occupational healthcare. At the visit, the information about the quality of diet can be utilized with the occupational healthcare professional. The client can utilize the self-care path (the Finnish Nutrition Path) for possible dietary changes independently or with the professional.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Treatment as usual in the occupational healthcare. |
| Intervention | Experimental | Utilization of the nutrition apps in the occupational healthcare. Receives: Other: Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition Path |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet quality
Healthy Diet Index (HDI) total score (range 0 - 100) and the seven sub scores: Meal pattern (range 0 - 10), Grains (range 0 - 20), Fruit and vegetables (range 0 - 20), Fats (range 0 - 15), Fish and meat (range 0 - 10), Dairy (range 0 - 10), and Snacks and treats (range 0 - 15). Higher scores mean better diet quality.
Measured: 12 weeks
User experiences of the apps
Self-created questions.
Measured: Baseline and follow-up (12 weeks)
Secondary outcomes (7)
Change in weight
Measured weight in kilograms.
Measured: 12 weeks
Change in BMI
Measured weight and self-reported height will be combined to report BMI in kg/m^2.
Measured: 12 weeks
Change in waist circumference
Measured waist circumference in centimeters.
Measured: 12 weeks
Change in blood pressure
Measured systolic and diastolic blood pressures in mmHg.
Measured: 12 weeks
Change in eating behavior
Questionnaire ecSatter Inventory 2.0TM, ecSI 2.0TM: Total score range 0 - 48 and the four subscales: Eating Attitudes (range 0 - 18), Contextual Skills (range 0 - 15), Food Acceptance (range 0 - 9), and Internal Regulation (range 0 - 6). Higher scores mean better eating competence.
Measured: 12 weeks
Change in other lifestyle factors
Questionnaire: short questions about physical activity, sleep, and smoking.
Measured: 12 weeks
Measures related to the general effectiveness
Questionnaire: questions about perceived health and well-being, quality of life, work productivity and activity impairment, consumer health activation, and life satisfaction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start11 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjukka Kolehmainen, Prof., Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923735
- Sponsor's protocol ID
- 262/2024
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Apps in Occupational Healthcare (Pilot Study of the FOODNUTRI Project)
- ClinicalTrials.gov ID
- NCT06923735
- Acronym / sponsor ID
- 262/2024
- Conditions
- Occupational Diseases, Overweight and Obesity, Dyslipidemias, Hypertension, Diabete Type 2, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Apr 2025 (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 aim of this study is to investigate (1) the user experiences and usability of the nutrition apps (the Finnish Nutrition Navigator and the Finnish Nutrition Path) in occupational health care from the perspective of both professionals and customers, (2) the impact on diet, eating behavior, perceived well-being (perceived state of health, quality of life, work and functional ability) and anthropometric indicators compared to treatment as usual, and (3) cost-effectiveness of using the nutrition apps.
Detailed description
For the occupational healthcare customer, the study will include two visits to the occupational healthcare: at baseline and after a 12-week follow-up. First, all volunteer participants enrolled in the study will belong to the control group and they will get the treatment as usual. Their weight, waist circumference, and blood pressure are measured at the visit and they are asked to answer a digital research questionnaire at both baseline and follow-up.
The rest of the volunteer participants enrolled in the study will belong to the intervention group. Before the visit at the occupational healthcare, they are asked to fill in the Finnish Nutrition Navigator and to read the automated feedback about the diet quality. The Finnish Nutrition Path can help in the dietary goal setting and it can be utilized together with the professional or independently. In addition, also weight, waist circumference, and blood pressure are measured at the visit and the participant is asked to answer a digital research questionnaire. The same procedure is done at both baseline and follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Treatment as usual in the occupational healthcare. |
| Intervention | Experimental | Other: Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition PathUtilization of the nutrition apps in the occupational healthcare. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employee of the certain employer
- Coming to the medical examination for employees whose work presents a special risk of illnessa OR coming to the dietitian because of dyslipidemia, high blood pressure, weight loss, weight management, type 2 diabetes, cardiovascular disease
- Understands written Finnish
Key exclusion criteria (3 listed)
- Pregnancy
- Eating disorder
- Severe challenges with diet (e.g., malabsorption, very restrictive diet due to several food allergies or other reasons)
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 |
|---|---|---|
| Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition PathParticipant fills in the food intake questionnaire of the Finnish Nutrition Navigator and receives an automated feedback on the diet before the visit to the occupational healthcare. At the visit, the information about the quality of diet can be utilized with the occupational healthcare professional. The client can utilize the self-care path (the Finnish Nutrition Path) for possible dietary changes independently or with the professional. | Other | Intervention |
Primary outcome
Change in diet quality
Time frame: 12 weeks
Healthy Diet Index (HDI) total score (range 0 - 100) and the seven sub scores: Meal pattern (range 0 - 10), Grains (range 0 - 20), Fruit and vegetables (range 0 - 20), Fats (range 0 - 15), Fish and meat (range 0 - 10), Dairy (range 0 - 10), and Snacks and treats (range 0 - 15). Higher scores mean better diet quality.
User experiences of the apps
Time frame: Baseline and follow-up (12 weeks)
Self-created questions.
7 secondary outcomes
Change in weight
Time frame: 12 weeks
Change in BMI
Time frame: 12 weeks
Change in waist circumference
Time frame: 12 weeks
Change in blood pressure
Time frame: 12 weeks
Change in eating behavior
Time frame: 12 weeks
Change in other lifestyle factors
Time frame: 12 weeks
Measures related to the general effectiveness
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Marjukka Kolehmainen, Prof. principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition Path in people with Occupational Diseases and Overweight and Obesity, run by University of Eastern Finland at 1 site in Finland.
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 3 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diet quality (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 17 Apr 2025.