Protocol summary

Summary
Aim of study: To determine if the Healthy Worker Programme can reduce weight and body mass index and improve physical activity, dietary intake and quality of working life. Study design: quasi-experimental (one worksite with programme, one worksite without) Target population: overweight and obese workers Inclusion criteria: Employees with body mass index of ≥23.0 kg/m2 are invited to participate. Exclusion criteria: pregnancy, medical conditions which precludes moderate exercise and affects walking (eg. severe osteoarthritis of knee, unstable angina, uncontrolled high blood pressure, acute injury to lower limbs), cease working at study site, unwilling to participate. Intervention: The six month ‘Healthy Worker Programme’ complex intervention, based on Socio-Ecological Model, to improve physical activity and dietary intake. Intervention at organisational, inter- and intra-individual levels. Includes monthly motivation, telephone counselling, health poster displays, healthier foods at cafeteria, colleague support. Controls receive health talks and pamphlets. Follow up: Assessments at baseline, third month (mid-programme) and sixth month (programme end). Assessment for sustainability of changes at three months after programme ends (ninth month). Measurements: Primary outcomes: weight and body mass index Secondary outcomes: i) Physical activity will be measured in mean steps per day (with use of pedometer) and using Malay short version International Physical Activity Questionnaire (IPAQ) ii) Dietary intake will be measured using 3-day dietary record. Mean daily energy intake, macro- and micronutrients will be assessed with NutritionistPro software by nutritionist. iii) Quality of working life with Malay validated Work-Related Quality of Life Scale 2.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015010620591N1
Registration date: 2015-02-05, 1393/11/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-02-05, 1393/11/16
Registrant information
Name
Nur Suffia Sulaiman
Name of organization / entity
Institute for Medical Research
Country
Malaysia
Phone
60-3-26162733
Email address
nursuffia@imr.gov.my
Recruitment status
Recruitment complete
Funding source
Postgraduate Research Fund, University of Malaya, Kuala Lumpur, Malaysia.
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The "Healthy Worker" Programme to Improve Dietary Intake, Physical Activity and Quality of Working Life among Klang Valley Office Workers: a quasi-experimental study
Public title
The Healthy Worker Programme
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Employees with a body mass index of ≥23.0 kg/m2 will be invited to participate in the study. Exclusion criteria: pregnancy, medical conditions which precludes moderate exercise and affects walking (eg. severe osteoarthritis of the knee, unstable angina, uncontrolled very high blood pressure, acute injury to lower limbs), cease to work at study site and unwilling to participate.
Age
From 21 years old to 58 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 256
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
quasi-experimental

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Ethics Committee of University Malaya Medical Centre, Kuala Lumpur
Street address
University Malaya Medical Centre
City
Kuala Lumpur
Postal code
59100
Approval date
2011-06-29, 1390/04/08
Ethics committee reference number
860.4

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
weight
Timepoint
baseline, 3rd,6th and 9th month
Method of measurement
digital weighing scale (kilograms)

2

Description
body mass index (used for sample calculation)
Timepoint
baseline, 3rd,6th and 9th month
Method of measurement
weighing scale and stadiometer (kg/m2)

Secondary outcomes

1

Description
physical activity
Timepoint
baseline, 3rd,6th and 9th month
Method of measurement
pedometer (steps/day) & International Physical Activity Questionnaire (MET-mins/week)

2

Description
Dietary intake
Timepoint
baseline, 6th and 9th month
Method of measurement
calorie analysis, macro- and micronutrient dietary analysis

3

Description
quality of working life
Timepoint
baseline, 3rd,6th and 9th month
Method of measurement
Malay validated Work-Related Quality of Life Scale-2

Intervention groups

1

Description
Controls: Health talks, pamphlets
Category
N/A

2

Description
Intervention:Healthy Worker Programme: physical activity & healthy diet intervention, health poster displays, healthy food at cafeteria, prize-giving for weight loss and increased steps per day, monthly motivation through office mail, telephone counselling.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Institute Tadbiran Awam Negara
Full name of responsible person
Dr Nur Suffia Sulaiman
Street address
Jalan Bukit Kiara
City
Kuala Lumpur

2

Recruitment center
Name of recruitment center
Jabatan Pendaftaran Negara
Full name of responsible person
Dr Nur Suffia Sulaiman
Street address
20, Persiaran Perdana, Presint 2
City
Putrajaya

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Postgraduate Research Fund, University of Malaya
Full name of responsible person
Muhammad Firdaus Zainalabidin
Street address
University of Malaya
City
Kuala Lumpur
Grant name
Grant code / Reference number
PV095-2011A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Postgraduate Research Fund, University of Malaya
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Institute for Medical Research
Full name of responsible person
Dr Nur Suffia Sulaiman
Position
Medical Officer
Other areas of specialty/work
Street address
Jalan Pahang
City
Kuala Lumpur
Province
Wilayah Persekutuan
Postal code
Phone
0060326162733
Fax
Email
nursuffia@imr.gov.my
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute for Medical Research
Full name of responsible person
Dr Nur Suffia Sulaiman
Position
Medical Officer
Other areas of specialty/work
Street address
Jalan Pahang
City
Kuala Lumpur
Province
Wilayah Persekutuan
Postal code
Phone
0060326162733
Fax
Email
nursuffia@imr.gov.my
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Institute for Medical Research
Full name of responsible person
Dr Nur Suffia Sulaiman
Position
Medical Officer
Other areas of specialty/work
Street address
Jalan Pahang
City
Kuala Lumpur
Province
Wilayah Persekutuan
Postal code
50588
Phone
0060326162733
Fax
0060326926542
Email
nursuffia@imr.gov.my
Web page address
www.imr.gov.my

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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