Trial Review

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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)
Scientific title
The impact of work-time nutrition as a success factor for enterprises and their employees in Satakunta (RAVI-study)
Secondary ID [1] 309712 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Work ability 330095 0
Work well-being 330097 0
Work productivity 330098 0
Sickness absence 330099 0
Health-related quality of life 330100 0
Nutrient intake and food habits 330101 0
Condition category
Condition code
Diet and Nutrition 326987 326987 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 326151 0
Prevention
Intervention code [2] 326317 0
Treatment: Other
Comparator / control treatment
During the 12- months intervention period, control group is not provided with any treatment.

Control group
Active

Outcomes
Primary outcome [1] 334843 0
Work ability is measured by using the Work Ability Index (WAI)
Timepoint [1] 334843 0
Baseline and 12 months post-intervention commencement
Primary outcome [2] 334844 0
Work well-being is measured using the Finnish Work Suction Test developed by the Finnish Institute of Occupational Health
Timepoint [2] 334844 0
Baseline and 12 months post-intervention commencement
Primary outcome [3] 334845 0
Health-related quality of life is assessed with EQ-5D-5L questionnaire
Timepoint [3] 334845 0
Baseline and 12 months post-intervention commencement
Secondary outcome [1] 422235 0
Nutrient intake and diet quality is assessed with 3-day food records
Timepoint [1] 422235 0
Baseline and 12 months post-intervention commencement
Secondary outcome [2] 422236 0
Food habits and eating behavior is measured with Food frequency questionnaire (FFQ)
Timepoint [2] 422236 0
Baseline and 12 months post-intervention commencement
Secondary outcome [3] 422237 0
Work productivity is measured with Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH)
Timepoint [3] 422237 0
Baseline and 12 months post-intervention commencement
Secondary outcome [4] 422238 0
Sickness absence is measured with the 5th question of the Work Ability Index (WAI)
Timepoint [4] 422238 0
Baseline and 12 months post-intervention commencement
Secondary outcome [5] 422239 0
Sleep, activity, recovery and work vitality is measured with the Polar Ignite 2 smart watch (only for intervention group)
Timepoint [5] 422239 0
Data from the smart watches is gathered 1, 6, and 12 months post-intervention commencement

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
24/10/2023
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
170
Accrual to date
170
Final
Recruitment outside Australia
Country [1] 25552 0
Finland
State/province [1] 25552 0
Satakunta

Funding & Sponsors
Funding source category [1] 313905 0
Government body
Name [1] 313905 0
European Regional Development Fund/ Regional Council of Satakunta
Country [1] 313905 0
Finland
Funding source category [2] 313917 0
University
Name [2] 313917 0
Satakunta University of Applied Sciences
Country [2] 313917 0
Finland
Primary sponsor type
University
Name
Satakunta University of Applied Sciences
Address
Satakunnankatu 23
28101 Pori
Finland
Country
Finland
Secondary sponsor category [1] 315778 0
None
Name [1] 315778 0
None
Address [1] 315778 0
None
Country [1] 315778 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313052 0
Ethics Committee of the wellbeing services county of Southwest Finland
Ethics committee address [1] 313052 0
Ethics committee country [1] 313052 0
Finland
Date submitted for ethics approval [1] 313052 0
17/04/2023
Approval date [1] 313052 0
13/06/2023
Ethics approval number [1] 313052 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126822 0
Dr Susanna Kunvik
Address 126822 0
SAMK, Satakunta University of Applied Sciences
Satakunnankatu 23,
28101 Pori
Finland
Country 126822 0
Finland
Phone 126822 0
+358447103204
Fax 126822 0
Email 126822 0
[email protected]
Contact person for public queries
Name 126823 0
Susanna Kunvik
Address 126823 0
SAMK, Satakunta University of Applied Sciences
Satakunnankatu 23,
28101 Pori
Finland
Country 126823 0
Finland
Phone 126823 0
+358447103204
Fax 126823 0
Email 126823 0
[email protected]
Contact person for scientific queries
Name 126824 0
Susanna Kunvik
Address 126824 0
SAMK, Satakunta University of Applied Sciences
Satakunnankatu 23,
28101 Pori
Finland
Country 126824 0
Finland
Phone 126824 0
+358447103204
Fax 126824 0
Email 126824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive data and complying with the Data Protection Act


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19231Study protocol  [email protected] Not yet published
19246Clinical study report  [email protected] 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.