Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001255875
Ethics application status
Approved
Date submitted
30/10/2020
Date registered
16/09/2021
Date last updated
16/09/2021
Date data sharing statement initially provided
16/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an integrated-Weight Management Programme on body weight among noncommunicable disease patients in Malaysian government primary care clinics.
Scientific title
Effect of an integrated-Weight Management Programme on body weight among noncommunicable disease patients in Malaysian government primary care clinics.
Secondary ID [1] 302546 0
Nil known
Universal Trial Number (UTN)
Trial acronym
i-WMP (integrated-Weight Management Programme)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 319418 0
cardiovascular diseases 321995 0
diabetes mellitus 321996 0
hypertension 321997 0
hyperlipidaemia 321998 0
cancer 321999 0
asthma 322000 0
Condition category
Condition code
Public Health 317420 317420 0 0
Health promotion/education
Diet and Nutrition 317421 317421 0 0
Obesity
Cardiovascular 319713 319713 0 0
Other cardiovascular diseases
Cardiovascular 319714 319714 0 0
Hypertension
Metabolic and Endocrine 319715 319715 0 0
Diabetes
Metabolic and Endocrine 319716 319716 0 0
Other metabolic disorders
Cancer 319717 319717 0 0
Any cancer
Respiratory 319718 319718 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The newly developed intervention programme named integrated-Weight Management Programme (i-WMP). Behaviour change wheel was used as the theoretical framework to develop the i-WMP, drawing on the behaviour change techniques. It consisted of dietary advice, physical activity, and behavioural intervention. There was a total of 10 units were included in this programme, as the following:

Session 1:
Unit 1: What is overweight and obesity?
Unit 2: How light am i today?
Unit 3: What is my goal?
Unit 4: How to eat and drink healthily?

Session 2:
Unit 5: Walking and brisk walking!
Unit 6: Healthy eating and active moving daily plan!

Session 3:
Unit 7: Did I achieve my goal?
Unit 8: Healthy snacking: fibre!
Unit 9: 0 Challenge!
Unit 10: Healthy eating and active moving daily plan!

The i-WMP promoted behaviour change (healthy eating and active moving) on noncommunicable disease patients' existing lifestyle. Hence, it aimed to reduce their body weight healthily as the primary outcome. The secondary outcomes in this trial including improvement of: body mass index; waist circumference; waist-to-height ratio; body fat percentage; knowledge, attitude, and practice towards dietary and physical activity; total physical activity MET-minutes/week and sitting time. Both primary and secondary outcomes were assessed at three different time points: baseline (week 0), immediate post-intervention (week 4), and three months (week 12).

The participants from intervention group received three sessions of education programme. Session 1 and 2 were implemented at week 0 and Session 3 was implemented at week 4 by a researcher (Tan Siew Tin, PhD candidate in Public Health). Session 1 and 2 took a total of two hours and 25 minutes, while Session 3 took one hour and 15 minutes. The i-WMP was conducted through face to face in a group of six to 10 participants by using slide presentation and short videos. Each participant was provided with a booklet (which was designed specifically for this study), healthy plate, pedometer and weighing scale. The programme was conducted in the meeting room of respective primary care clinic based on scheduled appointments.

Intervention group was taught to eat healthily according to the concept of Quarter Quarter Half in the Malaysian Healthy Plate. They were encouraged to achieve 10,000 steps per day and ultimately minimum 150 minutes of moderate intensity physical activity (brisk walk) per day. They also were asked to weigh themselves by weekly on every Saturday immediate after woke up, then recorded the readings in their booklets and informed the researcher on their measurements via WhatsApp or Short Message Service.

The adherence of intervention group's self-reported weekly body weight was expressed in percentage [Yes (received self-reported measurement from intervention group) versus No (did not receive self-reported measurement from intervention group)] from week 0 to week 12. Besides that, the session attendance checklists were used to record participant's attendance for each appointment, this was meant for adherence assessment of both groups (attendance rate).



Intervention code [1] 318861 0
Behaviour
Intervention code [2] 320636 0
Treatment: Other
Comparator / control treatment
Wait-list control group who received the standard health care during study duration; and the intervention programme after data collection (12 weeks post-study commencement).
Control group
Active

Outcomes
Primary outcome [1] 325453 0
Body weight (kg) measured using Omron KaradaScan Body Composition Monitor HBF-375.
Timepoint [1] 325453 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [1] 388009 0
Body mass index (kg per square metre) using calculation [body weight (kg) divided by height twice (square metre)].

Note: Height (cm) measured using Seca 213 portable stadiometer.
Timepoint [1] 388009 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [2] 388011 0
Waist circumference (cm) measured using Seca 201 ergonomic circumference measuring tape.
Timepoint [2] 388011 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [3] 388013 0
Waist-to-height ratio using calculation [waist (cm) divided by height (cm)}.

Note:
Height (cm) measured using Seca 213 portable stadiometer.
Waist circumference (cm) measured using Seca 201 ergonomic circumference measuring tape.

Timepoint [3] 388013 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [4] 388014 0
Body fat percentage measured using Omron KaradaScan Body Composition Monitor HBF-375.
Timepoint [4] 388014 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [5] 388015 0
Knowledge towards dietary score using the validated, pre-tested, and self-administered knowledge towards dietary questionnaire.

This questionnaire was adapted from Knowledge, Attitude, and Practices (KAP) survey in the previous study (Heng, 2011).
Timepoint [5] 388015 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [6] 388018 0
Attitude towards dietary score using the validated, pre-tested, and self-administered attitude towards dietary questionnaire.

This questionnaire was adapted from Knowledge, Attitude, and Practices (KAP) survey in the previous study (Heng, 2011).
Timepoint [6] 388018 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [7] 388019 0
Practice towards dietary score using the validated, pre-tested, and self-administered practice towards dietary questionnaire.

This questionnaire was adapted from Knowledge, Attitude, and Practices (KAP) survey in the previous study (Heng, 2011).
Timepoint [7] 388019 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [8] 388020 0
Knowledge towards physical activity score using the validated, pre-tested, and self-administered knowledge towards physical activity questionnaire.

This questionnaire was adapted from Knowledge, Attitude, and Practices (KAP) survey in the previous study (Heng, 2011).
Timepoint [8] 388020 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [9] 388021 0
Attitude towards physical activity score using the validated, pre-tested, and self-administered attitude towards physical activity questionnaire.

This questionnaire was adapted from Knowledge, Attitude, and Practices (KAP) survey in the previous study (Heng, 2011).
Timepoint [9] 388021 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [10] 388022 0
Practice towards physical activity score using the validated, pre-tested, and self-administered practice towards physical activity questionnaire.

This questionnaire was adapted from Knowledge, Attitude, and Practices (KAP) survey in the previous study (Heng, 2011).
Timepoint [10] 388022 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [11] 388023 0
Total physical activity MET-minutes/week score using the validated, pre-tested, and self-administered International Physical Activity Questionnaire short form.
Timepoint [11] 388023 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).
Secondary outcome [12] 388024 0
Total sitting time using the validated, pre-tested, and self-administered International Physical Activity Questionnaire short form.
Timepoint [12] 388024 0
Baseline (week 0), immediate post-intervention (week 4), and three months (week 12).

Eligibility
Key inclusion criteria
Noncommunicable disease patients with cardiovascular diseases, diabetes mellitus, hypertension, hyperlipidaemia, cancer, or asthma; aged 18 years old and above; body mass index of 25 kg per square metre and above. Participants must also give consent to participate this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lactating mothers, planning for pregnancy or pregnant women; having difficulty in understanding or speaking Malay; attending a weight loss programme (such as a structured commercial programme, pharmacotherapy or surgical therapy) during the study duration or three months before the research started; physical impairment that not fit for physical activities recommended in this programme; other special conditions included CVD that occurred recently, terminally ill, substances abuse, severe psychiatric illnesses, or history of eating disorder.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by using sequentially numbered, opaque sealed envelopes (SNOSE).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined based on two groups' comparison formula with the mean difference of body weight at 1.0 kg and the power of 80%. The cluster effect (ICC) and possibility of dropout or missing data were also taking into consideration.

IBM SPSS (version 23) was employed to obtain descriptive and inferential statistics. Descriptive statistics such as mean (standard deviation) or median (interquartile range) were obtained. Inferential analyses such as independent sample t-test/Mann-Whitney U test, chi square/fisher's exact test, and generalized linear mixed model (GLMM) were performed. The confidence interval (CI) was set at 95% and a level of significance of 0.05. Once randomised, all participants were included in the analysis, intent-to-treat principle was applied for lost follow-up,

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/01/2018
Date of last participant enrolment
Anticipated
Actual
21/09/2018
Date of last data collection
Anticipated
Actual
14/12/2018
Sample size
Target
244
Accrual to date
Final
244
Recruitment outside Australia
Country [1] 23065 0
Malaysia
State/province [1] 23065 0
Selangor

Funding & Sponsors
Funding source category [1] 306983 0
Government body
Name [1] 306983 0
Kementerian Pendidikan Tinggi Malaysia (Ministry of Higher Education)
Country [1] 306983 0
Malaysia
Primary sponsor type
University
Name
University Putra Malaysia
Address
Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 307659 0
None
Name [1] 307659 0
Address [1] 307659 0
Country [1] 307659 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307114 0
Medical Research and Ethics Committee, Ministry of Health Malaysia
Ethics committee address [1] 307114 0
Ethics committee country [1] 307114 0
Malaysia
Date submitted for ethics approval [1] 307114 0
Approval date [1] 307114 0
21/06/2017
Ethics approval number [1] 307114 0
Ethics committee name [2] 307147 0
Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia
Ethics committee address [2] 307147 0
Ethics committee country [2] 307147 0
Malaysia
Date submitted for ethics approval [2] 307147 0
Approval date [2] 307147 0
25/07/2017
Ethics approval number [2] 307147 0

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

Contacts
Principal investigator
Name 106082 0
Prof Sherina Mohd Sidik
Address 106082 0
Department of Psychiatry, Faculty of Medicine and Heath Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
Country 106082 0
Malaysia
Phone 106082 0
+60397692541
Fax 106082 0
Email 106082 0
[email protected]
Contact person for public queries
Name 106083 0
Tan Siew Tin
Address 106083 0
Department of Psychiatry, Faculty of Medicine and Heath Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
Country 106083 0
Malaysia
Phone 106083 0
+60397692541
Fax 106083 0
Email 106083 0
[email protected]
Contact person for scientific queries
Name 106084 0
Sherina Mohd Sidik
Address 106084 0
Department of Psychiatry, Faculty of Medicine and Heath Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
Country 106084 0
Malaysia
Phone 106084 0
+60397692541
Fax 106084 0
Email 106084 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


What supporting documents are/will be available?

No Supporting Document Provided



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.