Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000219482
Ethics application status
Approved
Date submitted
9/01/2025
Date registered
27/03/2025
Date last updated
27/03/2025
Date data sharing statement initially provided
27/03/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of South Asian food patterns in calorie restriction diets among young adults who are overweight and obese in Dhaka city
Scientific title
Effectiveness of South Asian Food Pattern in Calorie Restriction Diet on weight reduction among Young Adults with Overweight and Obesity in Dhaka City
Secondary ID [1] 313660 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 336231 0
Condition category
Condition code
Diet and Nutrition 332769 332769 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involved an 8-week randomized controlled trial with 120 young adults aged 18–35 years who were overweight or obese.
Participants were randomly assigned to two groups:
- Case Group (n=60): Followed a calorie-restriction (CR) diet based on South Asian food patterns, reducing calorie intake by 25% of baseline energy requirements. The macronutrient distribution was 50% carbohydrates, 18% protein, and 32% fats. Meals were designed following the Dietary Guidelines for Bangladesh (2013) and the Healthy Eating Pyramid (Nutrition Australia, 2013). They are only provided diet chart and meal suggestions.
Monitoring: Weight measurements were taken biweekly, and dietary adherence was assessed through self-reporting during weekly calls. They will maintain a food diary.
Follow-up: Participants were monitored for adherence and compliance throughout the 8 weeks.
Intervention code [1] 330260 0
Lifestyle
Comparator / control treatment
Control Group (n=60): Followed an ad libitum (AL) diet with no specific restrictions.
Control group
Active

Outcomes
Primary outcome [1] 340294 0
To measure the effectiveness of calorie restriction diet in weight reduction
Timepoint [1] 340294 0
Baseline, weeks 2, 4, 6 (primary timepoint) and 8 weeks post randomization
Primary outcome [2] 340465 0
To measure the effectiveness of calorie restriction diet in BMI reduction
Timepoint [2] 340465 0
Baseline, weeks 2, 4, 6 (primary timepoint) and 8 weeks post randomization
Secondary outcome [1] 443639 0
Diet Adherence
Timepoint [1] 443639 0
1, 2, 3, 4, 5, 6, 7, 8 weeks post randomization

Eligibility
Key inclusion criteria
1. No presence of any disease or infirmity
2.Those whose BMI is more than 22.9 i.e. Overweight and obese individuals
3. Not following any diet recently
4. Willing to follow a diet for 2 months
5. Living in Dhaka city and the surrounding area
6. Psychologically stable
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of any type of disease like diabetes, hypertension, cardiovascular disease
2. Any medical condition which influences body weight reduction
3. Taking any type of medicinal drug which influences body weight reduction
4. Smoking or drinking alcohol
5. Malnourished and double burdened malnourished patients
6. Pregnant and lactating mother
7. Having irregular menstrual cycles
8. Living outside of Dhaka
9. Psychologically unstable
10. Not willing to follow a diet
11. Exercise regularly

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All the statistical analysis and all other data processing were done by using the SPSS 16.0 windows program. Descriptive statistics were mainly used. Data were analyzed in terms of frequency distribution, percentage means, and standard deviation. Statistical tests such as paired t-test and correlation coefficient were used to determine the association between groups and selected various forms of nutritional status, behavioral status, and socioeconomic status. For tabular charts and a graphical representation, Microsoft word, Microsoft excel, and LaTex were used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2020
Date of last participant enrolment
Anticipated
Actual
31/01/2020
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
120
Accrual to date
Final
118
Recruitment outside Australia
Country [1] 26807 0
Bangladesh
State/province [1] 26807 0
Dhaka

Funding & Sponsors
Funding source category [1] 318125 0
Self funded/Unfunded
Name [1] 318125 0
Joyce Proggya Biswas
Country [1] 318125 0
Bangladesh
Funding source category [2] 318478 0
Self funded/Unfunded
Name [2] 318478 0
Umme Sabiha Farshi
Country [2] 318478 0
Bangladesh
Funding source category [3] 318479 0
Self funded/Unfunded
Name [3] 318479 0
Umme Batul
Country [3] 318479 0
Bangladesh
Funding source category [4] 318480 0
Self funded/Unfunded
Name [4] 318480 0
Jiniya Sanam Mim
Country [4] 318480 0
Bangladesh
Primary sponsor type
University
Name
Government College of Applied Human Science
Address
Country
Bangladesh
Secondary sponsor category [1] 320508 0
University
Name [1] 320508 0
Mawlana Bhashani Science and Technology University
Address [1] 320508 0
Country [1] 320508 0
Bangladesh

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316773 0
Project and Ethical Review Committee, Department of Food Technology and Nutritional Science, Mawlana Bhashani Science and Technology University
Ethics committee address [1] 316773 0
Ethics committee country [1] 316773 0
Bangladesh
Date submitted for ethics approval [1] 316773 0
16/12/2019
Approval date [1] 316773 0
02/01/2020
Ethics approval number [1] 316773 0
ref: 2020/01/stu/H-02

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

Contacts
Principal investigator
Name 138966 0
Miss Joyce Proggya Biswas
Address 138966 0
Bangladesh University of Health Sciences, 125, Technical Mor, 1 Darus Salam Rd, Dhaka 1216, Bangladesh
Country 138966 0
Bangladesh
Phone 138966 0
+8801315783352
Fax 138966 0
Email 138966 0
[email protected]
Contact person for public queries
Name 138967 0
Joyce Proggya Biswas
Address 138967 0
Bangladesh University of Health Sciences, 125, Technical Mor, 1 Darus Salam Rd, Dhaka 1216, Bangladesh
Country 138967 0
Bangladesh
Phone 138967 0
+8801315783352
Fax 138967 0
Email 138967 0
[email protected]
Contact person for scientific queries
Name 138968 0
Joyce Proggya Biswas
Address 138968 0
Bangladesh University of Health Sciences, 125, Technical Mor, 1 Darus Salam Rd, Dhaka 1216, Bangladesh
Country 138968 0
Bangladesh
Phone 138968 0
+8801315783352
Fax 138968 0
Email 138968 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.