The effectiveness of SLIM SHAPE 2.0 interventions in improving the health, wellness, and work productivity among working adults with overweight and obesity
| ISRCTN | ISRCTN17129075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17129075 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | UKM FPR.4/244/DCP-2018-005/1 |
| Sponsor | Universiti Kebangsaan Malaysia |
| Funder | Universiti Kebangsaan Malaysia |
- Submission date
- 03/08/2023
- Registration date
- 09/08/2023
- Last edited
- 08/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Approximately half of Malaysian employees are overweight and obese. It imposes a financial burden for employees and employers as it increases absenteeism and healthcare cost; decreases productivity and quality of life. Many weight reduction programs are effective but not sustainable. Thus, this study aims to determine the effectiveness and sustainability of a multicomponent weight loss program among employees with overweight and obesity in the workplace. In addition, factors influencing weight lost maintenance will be determined.
Who can participate?
Permanent staff of Universiti Kebangsaan Malaysia (Bangi campus) aged 20-59 years old
What does the study involve?
Participants are allocated into either the SLIMSHAPE 2.0 or control group based on their office zone. Participants in the SLIMSHAPE 2.0 group will receive multicomponent interventions that include dietary management, physical activity and exercise training, and aspect of mindfulness. These interventions will be delivered through lectures, interactive activities, and group exercise training provided by dietitians and sports physiologists. On the other hand, the control group will receive conventional dietary and health counseling at UKM Health Centre delivered by a dietitian and Medical Officer. They will also be given hand-outs on weight management and healthy lifestyle.
What are the possible benefits and risks of participating?
Participants will be able to learn about their health status through body composition measurements, blood tests, dietary intake, and physical activity status which will be explained in the first week of intervention.
No risks.
Where is the study run from?
Universiti Kebangsaan Malaysia
When is the study starting and how long is it expected to run for?
January 2019 to March 2021
Who is funding the study?
Universiti Kebangsaan Malaysia
Who is the main contact?
Associate Professor Dr Zahara Abdul Manaf, zaharamanaf@ukm.edu.my
Contact information
Principal investigator
Dietetic Program and Center for Healthy Aging and Wellness
Faculty of Health Science
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
53000
Malaysia
 ORCID ID |
0000-0002-5657-8608 |
|---|---|
| Phone | +60192764541 |
| zaharamanaf@ukm.edu.my |
Scientific
Dietetic Program and Center for Healthy Aging and Wellness
Faculty of Health Science
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
53000
Malaysia
| ORCID ID |
0000-0003-3754-8136 |
|---|---|
| Phone | +60193357706 |
| sitimunirah.abdulbasir@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional non-randomized trial |
| Secondary study design | Non randomised study |
| Participant information sheet | 44054 PIS (Eng Translation).pdf |
| Scientific title | The effectiveness of SLIM SHAPE 2.0 interventions in improving the health, wellness, and work productivity among the staff of Universiti Kebangsaan Malaysia |
| Study objectives | The SLIMSHAPE 2.0 interventions is more effective in reducing cardiovascular disease risks, maintaining ideal body weight, and improving quality of life and work productivity of the staff of Universiti Kebangsaaan Malaysia (Bangi) as compared to the control group |
| Ethics approval(s) |
Approved 01/07/2019, Secretariat of Medical Research and Innovation (Faculty of Medicine, Universiti Kebangsaan Malaysia, Level 6, Preclinical Building, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Kuala Lumpur, 56000, Malaysia; +603-91455003; nasirshafiee@ukm.edu.my), ref: UKM FPR.4/244/DCP-2018-005/1 |
| Health condition(s) or problem(s) studied | Reduction in cardiovascular risks and body weight, and improvement of work productivity and quality of life in employees with overweight and obesity |
| Intervention | Employees with overweight and obesity will be assigned to either the SLIMSHAPE 2.0 or control group based on their office zone in order to avoid selection bias. Those from Zone 1 will be assigned to the SLIMSHAPE 2.0 group, whereas employees from Zone 3 will be assigned to the control group. Participants in the SLIMSHAPE 2.0 group will receive interventions that include dietary management, physical activity and exercise training, and aspects of mindfulness, flow, and spirituality. The SLIMSHAPE 2.0 Intervention Program will be conducted weekly in a 3-hour session for 12 weeks. Lectures related to dietary management and four interactive and hands-on activities related to healthy eating such as calorie counting for food and drinks, healthy cooking demonstrations, a visit to the supermarket, and understanding food labels will all be delivered by a dietitian. Aspects related to physical activity will be delivered through lectures, demonstrations, and group exercise training. These activities will be carried out by sports physiologists and physiotherapists. In addition to these, participants will also receive mindfulness, flow, and spiritual interventions through Apps called MyMind throughout the intervention program. Participants in the control group will receive one face-to-face consultation about diet, physical activity, and behavior modification for weight loss from the Dietitian and Medical Officers at the Universiti Kebangsaan Malaysia Health Centre. Participants will also be given pamphlets on proper diet, exercise, and maintaining a healthy lifestyle. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Body weight change calculated as the difference (in kilograms) between measured weight at baseline and approximately 12 weeks after the intervention |
| Key secondary outcome measure(s) |
1. Body weight change calculated as the difference (in kilograms) between measured weight at baseline and approximately 9 months after enrollment |
| Completion date | 29/03/2021 |
Eligibility
| Participant type(s) | Employee |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 59 Years |
| Sex | All |
| Target sample size at registration | 148 |
| Total final enrolment | 152 |
| Key inclusion criteria | 1.Permanent staff of Universiti Kebangsaan Malaysia (Bangi) 2. Age between 20-59 years old 3. Non-shift worker 4. No chronic diseases such as cancer and renal failure 5. In either contemplation, preparation, action, or maintenance stage of change |
| Key exclusion criteria | 1. Temporary staff of Universiti Kebangsaan Malaysia (Bangi) 2. Pregnant staff 3. Blood pressure >=160/100 or <90/60mmHg 4. Uncontrolled blood glucose (HbA1c >=9.0%) 5. History of weight loss participation in the last 3 months prior to study 6. History of bariatric surgery 7. Prolonged sick leave (more than a month) 8. Chronic joint pain |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 31/01/2020 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
43600
Malaysia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during'/ the current study are not expected to be made available as data sharing has not been included as part of agreement in participant's consent form. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in English | 08/08/2023 | No | Yes | |
| Participant information sheet | in Malay | 08/08/2023 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | in English | 08/08/2023 | No | No | |
| Protocol file | in Malay | 08/08/2023 | No | No |
Additional files
- 44054 Protocol [Malay].pdf
- in Malay
- 44054 Protocol [Eng translation].pdf
- in English
- 44054 PIS (Malay).pdf
- in Malay
- 44054 PIS (Eng Translation).pdf
- in English
Editorial Notes
08/08/2023: Trial's existence confirmed by Universiti Kebangsaan Malaysia.
