- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923735
Nutrition Apps in Occupational Healthcare (Pilot Study of the FOODNUTRI Project)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kuopio, Finland, 70211
- University of Eastern Finland
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnancy
- Eating disorder
- Severe challenges with diet (e.g., malabsorption, very restrictive diet due to several food allergies or other reasons)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Treatment as usual in the occupational healthcare.
|
|
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Experimental: Intervention
Utilization of the nutrition apps in the occupational healthcare.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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12 weeks
|
|
User experiences of the apps
Time Frame: Baseline and follow-up (12 weeks)
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Self-created questions.
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Baseline and follow-up (12 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight
Time Frame: 12 weeks
|
Measured weight in kilograms.
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12 weeks
|
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Change in BMI
Time Frame: 12 weeks
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Measured weight and self-reported height will be combined to report BMI in kg/m^2.
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12 weeks
|
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Change in waist circumference
Time Frame: 12 weeks
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Measured waist circumference in centimeters.
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12 weeks
|
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Change in blood pressure
Time Frame: 12 weeks
|
Measured systolic and diastolic blood pressures in mmHg.
|
12 weeks
|
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Change in eating behavior
Time Frame: 12 weeks
|
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.
|
12 weeks
|
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Change in other lifestyle factors
Time Frame: 12 weeks
|
Questionnaire: short questions about physical activity, sleep, and smoking.
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12 weeks
|
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Measures related to the general effectiveness
Time Frame: 12 weeks
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Questionnaire: questions about perceived health and well-being, quality of life, work productivity and activity impairment, consumer health activation, and life satisfaction.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marjukka Kolehmainen, Prof., University of Eastern Finland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 262/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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