Home » Trials » SLCTR/2020/025
Dietary practices, social relations and intervention to change for a healthy diet within office community of government offices in Galle district
-
SLCTR Registration Number
SLCTR/2020/025
Date of Registration
The date of last modification
Dec 15, 2020
Scientific Title of Trial
Dietary practices, social relations and intervention to change for a healthy diet within office community of government offices in Galle district
Public Title of Trial
A randomized controlled trial on the efficacy of dietary interventions for improving the diet in government office workers in the Galle district
Disease or Health Condition(s) Studied
Dietary behavior
Scientific Acronym
None
Public Acronym
None
Brief title
An interventional study to assess the efficacy of a dietary intervention on office workers
Universal Trial Number
U1111-1262-7316
Any other number(s) assigned to the trial and issuing authority
2020/P/105 Ethical Review committee, Faculty of medicine, University of Ruhuna
What is the research question being addressed?
Is a set of interventions based on transtheoritical model effective in bringing about healthy dietary behavior in government office workers?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study will be conducted in selected government offices in Galle district
Selected offices will be randomized using simple randomization technique according to a random sequence generated by a random sequence generator available online.
Two types of interventions will be applied for workers depending on their stage of change.
1. For pre-contemplators and contemplators
•Thirty minute lecture at the beginning of each month for three months under following topics in order:
•Non-communicable diseases and risk factors
•Risks of unhealthy diet and benefits of a healthy diet
•How to change to a healthy diet
- Each lecture will be followed by once a week booster of the content through SMS or a video clip shared through social media.
The lectures will be delivered by a medical officer.
2. For rest of the stages (preparation, action and maintenance)
•A serving (as defined in food based dietary guidelines) counter* will be introduced with recommended numbers of servings of food. Recommended number of servings will be titrated according to pre-intervention BMI.
•Adherence to the practice will be assessed** once in two weeks
serving counter – will be a mobile app where subjects are supposed to tick the check boxes for number of servings from each food group they had consumed throughout the day. For those who have not got smart phones, a card (one per day) with a similar layout will be provided to record the number of servings. All subjects selected will be trained on how to mark the food intake and they will be familiarized with counting the servings.
*assessment of adherence – mobile app will be programmed to record two weeks data with the date of filling out the serving counter. Principle investigator or a data collector will visit intervention clusters and assess adherence by checking mobile apps and filled cards.
Inclusion criteria
20-30 clerical type workers who have been working at the particular office for at least one month from 20 selected government offices in Galle district.
Exclusion criteria
Workers involved in manual work as their office duties Workers who are on special dietary recommendations
Primary outcome(s)
|
1.
A progression of stages of change from pre-action stage (pre-contemplation, contemplation or preparation) to action stage (action or maintenance) - using a set of questions comprising of four questions which has been adopted from 5 a day project (Havas et al., 1995). |
[ 3 months ] |
Secondary outcome(s)
|
1.
A behavior change from unhealthy to healthy eating using 24 hour dietary recall |
[ 3 months ] |
Target number/sample size
600
Countries of recruitment
Sri Lanka
Anticipated start date
2020-12-21
Anticipated end date
2021-04-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
self funded
Regulatory approvals
Approved by Board of Studies for Community Medicine, Post Graduate Institute of Medicine, Colombo
Status
Approved
Date of Approval
2020-08-24
Approval number
2020/P/105
Details of Ethics Review Committee
| Name: | ERC - Faculty of Medicine Ruhuna |
| Institutional Address: | Ethical review committee, Faculty of medicine, University of Ruhuna, Galle |
| Telephone: | 091 2232801 |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
G. J . Chandana
Postgraduate trainee
Department of Community Medicine
Faculty of Medicine
University of Ruhuna
091 2234017
0714201612
m31635@pgim.cmb.ac.lk
Contact Person for Public Queries
Dr (Mrs) C.J. Wijesinghe
Head/ Senior Lecturer
Department of Community Medicine
Faculty of Medicine University of Ruhuna
091 2234017
0718186934
cjw@med.ruh.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
