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


Date of Registration

15 Dec 2020

The date of last modification

Dec 15, 2020

Application Summary

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


Public Acronym


Brief title

An interventional study to assess the efficacy of a dietary intervention on office workers

Universal Trial Number


Any other number(s) assigned to the trial and issuing authority

2020/P/105 Ethical Review committee, Faculty of medicine, University of Ruhuna

Trial Details

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


Study design


Randomized controlled trial


Masking not used


Standard therapy/practice





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)


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)


A behavior change from unhealthy to healthy eating using 24 hour dietary recall


3 months


Target number/sample size


Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

self funded

Regulatory approvals

Approved by Board of Studies for Community Medicine, Post Graduate Institute of Medicine, Colombo

State of Ethics Review Approval



Date of Approval


Approval number


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 & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

G. J . Chandana
Postgraduate trainee
Department of Community Medicine Faculty of Medicine University of Ruhuna
091 2234017


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


Primary study sponsor/organization

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results