Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001159640
Ethics application status
Approved
Date submitted
7/05/2023
Date registered
8/11/2023
Date last updated
8/11/2023
Date data sharing statement initially provided
8/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Combination of Behavioural Intervention and Nutrition Education with Brown Rice (COMBINE-BROWN) Weight Loss Program on Body Composition and Oxidative Stress among Overweight and Obese Adults.
Scientific title
Effect of Combination of Behavioural Intervention and Nutrition Education with Brown Rice (COMBINE-BROWN) Weight Loss Program on Body Composition and Oxidative Stress among Overweight and Obese Adults.
Secondary ID [1] 309419 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
COMBINE-BROWN clinical weight loss intervention
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obese 329673 0
Overweight 330619 0
Condition category
Condition code
Diet and Nutrition 326575 326575 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The weight loss study incorporates nutrition education, exercise, and behavioral modification approach, with brown rice consumption. The study involves a 12-week intervention phase and another 12 week maintenance phase. The participants are allocated into two groups, the intervention and control group. The intervention group receives 12-week behavioral weight loss intervention study, with health education on brown rice and incorporation of brown rice as daily diet regimen. The study is conducted in Universiti Sains Malaysia, Kelantan, Malaysia. It must be emphasised that the weekly nutritional, behavioural, and exercise sessions were conducted together in the same session. Furthermore, the group sessions were conducted when there was a requirement to conduct an in-depth discussion and encouragement of peer support among the participants; meanwhile, individual sessions were conducted when there was a need for individual dietary advice or health concern.

The experienced nutritionists and dietitians deliver the nutrition education modules, which will be conducted approximately one hour session for 12 weeks, using the local languages with simple sentences. These modules included general nutrition knowledge, based on Malaysian Dietary Guidelines. The healthy regimen such as Malaysian Food Pyramid and Malaysian Healthy Plate were introduced to the participants as a guideline for healthy diet (MOH, 2021). The twelves modules of the Nutrition Education Modules include Introduction of Obesity and Risk of Obesity, Obesity and Energy Balance, Food Pyramid, Food Serving Size, Carbohydrate, Fat and Protein, Weight Changes Challenges, Food Labelling, Fibre, Vitamins and Minerals, Weight Management, and Total Weight Changes.

A total of 12 classes are scheduled weekly during the intervention period, using face-to-face approach. For the intervention group, the participants are prescribed with seven cups of brown rice every week and they are required to consume at least one serving of brown rice each day.

The exercise components are delivered weekly by fitness instructors in groups. The exercise regimen includes brisk walking (approximately one hour), aerobic exercise (30 minutes), and dumbbell resistance exercise (30 minutes) (Matsuo and Suzuki, 1999) for 12 classes over 12 weeks intervention period. The intensity is gradually increased from low to intermediate, with about 33 in each groups. The intensity of physical activity level will be assessed using Malay version of the International Physical Activity Questionnaires (IPAQ-BM) (IPAQ, 2004).

The behavioral modification approach includes goal-monitoring, individual and group counselling, self-monitoring, and problem solving (Burgess et al, 2017). For the maintenance phase, the participants are required to continue the behavioral weight loss regimen for another 12 week after the intervention. The food diary is distributed to each participants to record their daily food intakes and served as self-monitoring purposes. For individual and group counselling, the recorded food diary will be discussed individually or in group with the nutritionists or dietitians. The participants will be advised to change the type and amount of their food intakes. Moreover, for problem solving, the problem encountered and the possible solution during the weight loss will be also discussed individually or in groups with the researchers. The discussion session will be conducted approximately one hour for 12 classes over 12 weeks intervention period. The classes will be conducted using face-to-face method. The Malay version of Impact Weight of Quality of Life-LITE (Kolotkin, 2017) will be used to assess the impact of weight on quality of life among the participants. The session attendance checklist will be used to assess the attendance of the participants in the behavioural weight loss program, which integrates nutrition education modules, exercise regimen, and behavioural weight loss approach.
Intervention code [1] 325850 0
Lifestyle
Intervention code [2] 326237 0
Behaviour
Comparator / control treatment
Usual care group comprises of nutritional, physical exercise, and behavioural modification by maintaining white rice as a dietary regimen, which is the same as provided to the intervention group. However, the intervention group consume brown rice as daily diet regimen, meanwhile, the usual care group continue their white rice as daily diet regimen for the 12 week intervention period. The control group receives a 12-week behavioral weight loss package, with no introduction and consumption of brown rice.
Control group
Active

Outcomes
Primary outcome [1] 334423 0
Body weight is assessed using electronic digital weighing scale, for the changes in intervention and maintenance phase between control and intervention group.
Timepoint [1] 334423 0
Baseline (0-week), post-intervention (12-week post-baseline), and follow-up (24-week Follow-up-baseline)
Primary outcome [2] 334985 0
Body fat percentage is assessed using bioelectrical impedance analyzer, for the changes in the intervention and maintenance phase between control and intervention group.
Timepoint [2] 334985 0
Baseline (0-week), post-intervention (12-week post-baseline), and follow-up (24-week Follow-up-baseline)
Primary outcome [3] 334986 0
Blood samples will be collected to assess the antioxidant levels using oxidative stress biomarkers, for the changes in the intervention between control and intervention group. The biomarkers included glutathione peroxidase and catalase.
Timepoint [3] 334986 0
Baseline (0-week), post-intervention (12-week post-baseline)
Secondary outcome [1] 420580 0
Blood samples will be collected to assess the lipid profiles, for the changes in the intervention between control and intervention group.
Timepoint [1] 420580 0
Baseline (0-week), post-intervention (12-week post-baseline)
Secondary outcome [2] 422637 0
Physical activity level using International Physical Activity Questionnaires (IPAQ)
Timepoint [2] 422637 0
Baseline (0-week), post-intervention (12-week post-baseline), and follow-up (24-week Follow-up-baseline)
Secondary outcome [3] 422638 0
The total scores of Impact of Weight on Quality of Life (IWQOL) using IWQOL-LITE questionnaires.
Timepoint [3] 422638 0
Baseline (0-week), post-intervention (12-week post-baseline), and follow-up (24-week Follow-up-baseline)
Secondary outcome [4] 422639 0
Nutrients intakes using 24-hour dietary recall method
Timepoint [4] 422639 0
Baseline (0-week), post-intervention (12-week post-baseline), and follow-up (24-week Follow-up-baseline)
Secondary outcome [5] 423909 0
Blood samples will be collected to assess the renal profiles, for the changes in the intervention between control and intervention group.
Timepoint [5] 423909 0
Baseline (0-week), post-intervention (12-week post-baseline)
Secondary outcome [6] 423910 0
Blood samples will be collected to assess the fasting blood glucose, for the changes in the intervention between control and intervention group.
Timepoint [6] 423910 0
Baseline (0-week), post-intervention (12-week post-baseline)

Eligibility
Key inclusion criteria
1. Healthy adults
2. BMI similar or more than 27 kg/m2
3. Able to do exercise or walking without aid
4, Undergo medical examination
5. Willing to consume brown rice for three months
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Diagnosed as mental illness
2. Pregnant
3. Exclude those who participate in other weight loss program during the study period

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Quasi-experimental design. Allocation into control and intervention groups are not randomised.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Parametric test, include paired-t-test is used to determine within-groups mean changes in control and and intervention groups. Non-parametric test, include Wilcoxon Signed Rank test is used to determine the median changes in control and intervention groups. Repeated measure ANOVA is used to measure the primary outcomes in the study.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/06/2017
Date of last participant enrolment
Anticipated
Actual
28/03/2019
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
132
Accrual to date
Final
103
Recruitment outside Australia
Country [1] 25390 0
Malaysia
State/province [1] 25390 0
Kelantan/Kubang Kerian

Funding & Sponsors
Funding source category [1] 313612 0
University
Name [1] 313612 0
Research University Individual (USM)
Country [1] 313612 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia (USM)
Address
Universiti Sains Malaysia, 11800 Penang, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 315406 0
None
Name [1] 315406 0
Address [1] 315406 0
Country [1] 315406 0
Other collaborator category [1] 282636 0
Other Collaborative groups
Name [1] 282636 0
Global Nutritional and Epidemiologic Transition (GNET), Harvard University
Address [1] 282636 0
677 Huntington Avenue Boston, MA 02115
Country [1] 282636 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312787 0
Human Research Ethics Committee Universiti Sains Malaysia
Ethics committee address [1] 312787 0
Ethics committee country [1] 312787 0
Malaysia
Date submitted for ethics approval [1] 312787 0
16/03/2017
Approval date [1] 312787 0
24/05/2017
Ethics approval number [1] 312787 0
USM/JEPeM/17030149

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

Contacts
Principal investigator
Name 125918 0
A/Prof Rohana Abdul Jalil
Address 125918 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Malaysia.
Country 125918 0
Malaysia
Phone 125918 0
+6097676637
Fax 125918 0
+6097653370
Email 125918 0
[email protected]
Contact person for public queries
Name 125919 0
Rohana Abdul Jalil
Address 125919 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Malaysia.
Country 125919 0
Malaysia
Phone 125919 0
+6097676637
Fax 125919 0
+6097653370
Email 125919 0
[email protected]
Contact person for scientific queries
Name 125920 0
Rohana Abdul Jalil
Address 125920 0
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia, 16150 Kubang Kerian, Malaysia.
Country 125920 0
Malaysia
Phone 125920 0
+6097676637
Fax 125920 0
+6097653370
Email 125920 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
To protect the patients' data and confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19063Study protocol    385715-(Uploaded-02-05-2023-14-55-11)-Study-related document.pdf
19064Informed consent form    385715-(Uploaded-02-05-2023-15-00-27)-Study-related document.pdf
19065Ethical approval    385715-(Uploaded-02-05-2023-15-06-31)-Study-related document.pdf



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.