Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12623000743662
Ethics application status
Approved
Date submitted
26/05/2023
Date registered
10/07/2023
Date last updated
4/12/2023
Date data sharing statement initially provided
10/07/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
The impact of work-time nutrition as a success factor for enterprises and their employees in Satakunta (RAVI-study)
Query!
Scientific title
The impact of work-time nutrition as a success factor for enterprises and their employees in Satakunta (RAVI-study)
Query!
Secondary ID [1]
309712
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Work ability
330095
0
Query!
Work well-being
330097
0
Query!
Work productivity
330098
0
Query!
Sickness absence
330099
0
Query!
Health-related quality of life
330100
0
Query!
Nutrient intake and food habits
330101
0
Query!
Condition category
Condition code
Diet and Nutrition
326987
326987
0
0
Query!
Other diet and nutrition disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Participants in the intervention group receive multifactorial and tailored nutritional guidance for 12 months including
1) tailored nutritional guidance 3-4 times
2) personal nutritional plan
3) opportunity to participate “Work well-being with nutrition” - online training
4) Eat@Work- mobile application to follow their own eating
5) use of smart watch to follow own physical activity and sleep
6) a comprehensive information package about own health
Tailored nutritional guidance is given during the 12-month intervention period 3-4 times face to face individually by the study nutritionist. One guidance session lasts for 1-2 hours, and it is given at the participant’s workplace if possible, or at the premises of Satakunta University of Applied Sciences. All nutritional guidance sessions are given by the same study nutritionist. Nutritional guidance is based on the results of participant’s nutritional status, nutrient intake and eating behaviour, background information, and the discussions with the participant and the nutritionist. Different booklets (from the The Association of Clinical and Public Health Nutritionists in Finland and from the Eat@Work project) about healthy nutrition are handed during the sessions. The motivational guidance method is used in the nutritional guidance.
All intervention group participants are provided a personal nutritional plan during the first nutritional guidance session, when the nutritionist and the participant discuss appropriate nutritional aims to improve eating habits. The nutritional guidance is based on the Finnish Nutrition and food recommendations (2014) and based on the new The Nordic Nutrition Recommendations (2022). The personal nutritional plan is reviewed and adjusted during the latter guidance sessions if needed. The adherence of the nutritional guidance and personal nutritional plan is measured with the GAS method, that allows the participant and the nutritionist to jointly define the achievement of goals of the nutritional guidance and plan on a five-step scale. Also, participants fill out a short feedback questionnaire in the last nutritional guidance session
The participants will take part in “Work well-being with nutrition” -online training” that has eight different modules which include different nutritional information about healthy eating and tasks for the participants. Each module opens every two weeks, so the overall duration of the online training is four months, and it is completed within the 12-month study period. Completing each module will take minimum of half an hour, but each module will include additional information for those interested. The training is created by nutritionists specifically to cover topics related to nutrition and well-being of working age participants. The online training is built in a Moodle learning platform provided by SAMK, where the participation and adherence is assessed by the percentage of assignments completed and feedback.
The Eat@Work- mobile application is instructed and encouraged to use (monthly, 15 minutes) during the intervention to strengthen the effects of the nutritional guidance. The Eat@Work mobile application includes nutritional information, tests, and videos to support changes in eating habits. Participants use the application to collect food records. At baseline and at final measurements participants take pictures of their foods and drinks for three days via the application. Participants send the food records (via application) to the study nutritionist, who analyzes the food records. The results are discussed in the nutritional guidance.
Participants in the intervention group use Polar® Ignite 2 fitness smart watches to follow their own physical activity, recovery, work vitality and sleep. The watch provides personalized guidance for workouts and sleep based on the collected data. The aim of the smart watch use is to support nutritional changes and to gather data to investigate the relationship between nutrition, activity/sleep and work-related outcomes.
Based on the information gathered at the baseline measurements, the intervention group volunteers will get a comprehensive package about their health and well-being, which is given in the first nutritional guidance (orally) sessions during the intervention study period. For example, if participant has a high risk for cardiovascular diseases, the nutritionist will give lifestyle advise to minimize the risk.
Query!
Intervention code [1]
326151
0
Prevention
Query!
Intervention code [2]
326317
0
Treatment: Other
Query!
Comparator / control treatment
During the 12- months intervention period, control group is not provided with any treatment.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
334843
0
Work ability is measured by using the Work Ability Index (WAI)
Query!
Assessment method [1]
334843
0
Query!
Timepoint [1]
334843
0
Baseline and 12 months post-intervention commencement
Query!
Primary outcome [2]
334844
0
Work well-being is measured using the Finnish Work Suction Test developed by the Finnish Institute of Occupational Health
Query!
Assessment method [2]
334844
0
Query!
Timepoint [2]
334844
0
Baseline and 12 months post-intervention commencement
Query!
Primary outcome [3]
334845
0
Health-related quality of life is assessed with EQ-5D-5L questionnaire
Query!
Assessment method [3]
334845
0
Query!
Timepoint [3]
334845
0
Baseline and 12 months post-intervention commencement
Query!
Secondary outcome [1]
422235
0
Nutrient intake and diet quality is assessed with 3-day food records
Query!
Assessment method [1]
422235
0
Query!
Timepoint [1]
422235
0
Baseline and 12 months post-intervention commencement
Query!
Secondary outcome [2]
422236
0
Food habits and eating behavior is measured with Food frequency questionnaire (FFQ)
Query!
Assessment method [2]
422236
0
Query!
Timepoint [2]
422236
0
Baseline and 12 months post-intervention commencement
Query!
Secondary outcome [3]
422237
0
Work productivity is measured with Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Query!
Assessment method [3]
422237
0
Query!
Timepoint [3]
422237
0
Baseline and 12 months post-intervention commencement
Query!
Secondary outcome [4]
422238
0
Sickness absence is measured with the 5th question of the Work Ability Index (WAI)
Query!
Assessment method [4]
422238
0
Query!
Timepoint [4]
422238
0
Baseline and 12 months post-intervention commencement
Query!
Secondary outcome [5]
422239
0
Sleep, activity, recovery and work vitality is measured with the Polar Ignite 2 smart watch (only for intervention group)
Query!
Assessment method [5]
422239
0
Query!
Timepoint [5]
422239
0
Data from the smart watches is gathered 1, 6, and 12 months post-intervention commencement
Query!
Eligibility
Key inclusion criteria
- has at least 12-month contract of employment in the recruited company
- ready to commit to either research group for a period of 12 months
- being able to read and understand Finnish well enough to give informed consent, to receive nutritional guidance and to use mobile app
- no clinically unstable diseases or conditions which could potentially be aggravated by the intervention
- having access to and being able to use a smartphone
- giving informed consent to participate in the study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- do not have contracts to work during the study period
- medical illness that is clinically unstable or in terminal stage, and which could potentially be aggravated by the intervention
- severe eating disorder (e.g. anorexia, bulimia and binge-eating disorder)
- harmful use of alcohol (AUDIT-C)
- women who are pregnant
- is participating or has recently participated (approx. 5 years) in another nutrition intervention
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer after baseline measurements, randomization is conducted by a person unrelated to the study
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
The sample size is calculated based on the expected change in the Work Ability Index (WAI) measuring work ability. Work ability is expected to change in the intervention group from 43 points to 44.5 points. The assumption is that work ability does not change in the control group. The calculation is based on estimated power of 0.8. The calculated sample size is 170, meaning 85 participants per group (ß 0.2, a 0.05). The sample size was estimated using Clincalc.
The results of the study is analyzed with IBM SPSS Statistics program and with STATA program. The normality of variables will be evaluated graphically and with the Shapiro-Wilk W test. Statistical comparisons between groups will be done using the analysis of independent samples t-test or Chi-square test, or Mann-Whitney U-test for nonparametric variables. The main outcome measures are subjected to analysis of covariance (ANCOVA).
The bootstrap method may be used when the theoretical distribution of the test statistics is
unknown or in the case of a violation of the assumptions (e.g. non-normality).
Hommel’s adjustment may be applied to correct levels of significance for multiple testing, if appropriate.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2023
Query!
Actual
24/10/2023
Query!
Date of last participant enrolment
Anticipated
1/03/2024
Query!
Actual
Query!
Date of last data collection
Anticipated
1/04/2025
Query!
Actual
Query!
Sample size
Target
170
Query!
Accrual to date
170
Query!
Final
Query!
Recruitment outside Australia
Country [1]
25552
0
Finland
Query!
State/province [1]
25552
0
Satakunta
Query!
Funding & Sponsors
Funding source category [1]
313905
0
Government body
Query!
Name [1]
313905
0
European Regional Development Fund/ Regional Council of Satakunta
Query!
Address [1]
313905
0
Pohjoisranta 11 D
PO Box 260, 28101 Pori Finland
Query!
Country [1]
313905
0
Finland
Query!
Funding source category [2]
313917
0
University
Query!
Name [2]
313917
0
Satakunta University of Applied Sciences
Query!
Address [2]
313917
0
Satakunnankatu 23
28101 Pori
Finland
Query!
Country [2]
313917
0
Finland
Query!
Primary sponsor type
University
Query!
Name
Satakunta University of Applied Sciences
Query!
Address
Satakunnankatu 23
28101 Pori
Finland
Query!
Country
Finland
Query!
Secondary sponsor category [1]
315778
0
None
Query!
Name [1]
315778
0
None
Query!
Address [1]
315778
0
None
Query!
Country [1]
315778
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
313052
0
Ethics Committee of the wellbeing services county of Southwest Finland
Query!
Ethics committee address [1]
313052
0
Secretary of the Ethics Committee The wellbeing services county of Southwest Finland Tyks U-hospital Kiinamyllynkatu 4-8 UB3 PO Box 52 FI-20521 Turku
Query!
Ethics committee country [1]
313052
0
Finland
Query!
Date submitted for ethics approval [1]
313052
0
17/04/2023
Query!
Approval date [1]
313052
0
13/06/2023
Query!
Ethics approval number [1]
313052
0
Query!
Summary
Brief summary
Workplaces are a fruitful environment to support workers' eating habits, since adults spend almost half of their waking hours at work. Regular eating and nutritious meals help to promote well-being at work and beyond. Supporting employee health and well-being with workplace health promotion programs focusing on dietary changes and healthy eating including personal and educational components, environmental components and multi-component strategies have been proven to be effective. Recruiting new workforce in the more rural areas of Finland, such as Satakunta, has been found to be problematic. Coincidently there is not enough graduating young workforce, elder workers are retiring, and increasing numbers of health problems are affecting the share of Finnish working age population. To optimize the use of the existing workforce health promotion interventions focusing on nutrition have been suggested to better the health and well-being of the current working age Finns in Satakunta and beyond. The RAVI trial is a randomized, controlled trial (RCT) exploring the effectiveness of personal nutritional guidance on work ability, work productivity, sickness absence, work well-being, health-related quality of life and nutrition. Participants are working-aged (= 18 years) employees (n=170) in six different companies located in Satakunta. The twelve-month intervention in the intervention group (IG) includes 3-4 times tailored nutritional guidance, personal nutritional plan, “Work well-being with nutrition” - online training, and smart watches to follow their own physical activity and sleep. Participants in the control group do not receive any nutritional guidance in the twelve-month study period, but after the final measurements they get one nutritional guidance session and access to online training. The trial has comprehensive baseline and final measurements, that include an electronic questionnaire assessing work-related outcomes, background and lifestyle information, blood tests at the laboratory and a nurse’s appointment with blood pressure measuring. Measurements for work-related outcomes: Work ability and sickness absence is measured with the Work Ability Index (WAI), work well-being with WAI and the Suction of work-test, and Work productivity is measured with Work Productivity and Activity Impairment Questionnaire (WPAI:GH). In addition health-related quality of life is measured with EQ-5D-5L questionnaire, Dietary assessment is done using a Food Frequency Questionnaire and a 3-day food record. Food records are kept with Eat@Work mobile application. Only amongst the intervention group protein intake is tested with protein intake screener and sleep and activity are measured with smartwatch. This study will provide nationally important data on how workplace nutrition guidance affects quality of life, work performance, sickness absence, eating behavior and dietary intake among working age Finns.
Query!
Trial website
ravi.samk.fi
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
126822
0
Dr Susanna Kunvik
Query!
Address
126822
0
SAMK, Satakunta University of Applied Sciences
Satakunnankatu 23,
28101 Pori
Finland
Query!
Country
126822
0
Finland
Query!
Phone
126822
0
+358447103204
Query!
Fax
126822
0
Query!
Email
126822
0
susanna.kunvik@samk.fi
Query!
Contact person for public queries
Name
126823
0
Susanna Kunvik
Query!
Address
126823
0
SAMK, Satakunta University of Applied Sciences
Satakunnankatu 23,
28101 Pori
Finland
Query!
Country
126823
0
Finland
Query!
Phone
126823
0
+358447103204
Query!
Fax
126823
0
Query!
Email
126823
0
susanna.kunvik@samk.fi
Query!
Contact person for scientific queries
Name
126824
0
Susanna Kunvik
Query!
Address
126824
0
SAMK, Satakunta University of Applied Sciences
Satakunnankatu 23,
28101 Pori
Finland
Query!
Country
126824
0
Finland
Query!
Phone
126824
0
+358447103204
Query!
Fax
126824
0
Query!
Email
126824
0
susanna.kunvik@samk.fi
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Sensitive data and complying with the Data Protection Act
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
susanna.kunvik@samk.fi
Not yet published
Clinical study report
susanna.kunvik@samk.fi
Not yet published
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF