NCT06923735

Brief 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 (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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 11, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 11, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

9 months

First QC Date

March 24, 2025

Last Update Submit

April 16, 2025

Conditions

Occupational DiseasesOverweight and ObesityDyslipidemiasHypertensionDiabete Type 2Cardiovascular DiseasesDiet, HealthyDiet HabitFood Selection

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • User experiences of the apps

    Self-created questions.

    Baseline and follow-up (12 weeks)

Secondary Outcomes (7)

  • Change in weight

    12 weeks

  • Change in BMI

    12 weeks

  • Change in waist circumference

    12 weeks

  • Change in blood pressure

    12 weeks

  • Change in eating behavior

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Treatment as usual in the occupational healthcare.

Intervention

EXPERIMENTAL

Utilization of the nutrition apps in the occupational healthcare.

Other: Utilization of the Finnish Nutrition Navigator and the Finnish Nutrition Path

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Eating disorder
  • Severe challenges with diet (e.g., malabsorption, very restrictive diet due to several food allergies or other reasons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

Location

MeSH Terms

Conditions

Occupational DiseasesOverweightObesityDyslipidemiasHypertensionDiabetes Mellitus, Type 2Cardiovascular DiseasesFeeding BehaviorFood Preferences

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesVascular DiseasesDiabetes MellitusGlucose Metabolism DisordersEndocrine System DiseasesBehavior, AnimalBehavior

Study Officials

  • Marjukka Kolehmainen, Prof.

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2025

First Posted

April 11, 2025

Study Start

April 11, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)