Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000080426
Ethics application status
Approved
Date submitted
20/01/2016
Date registered
25/01/2016
Date last updated
8/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Promotion of a balanced diet for pregnant women to improve birthweight of infants: a cluster randomised controlled trial in rural Bangladesh
Scientific title
Making a balanced plate for pregnant women to improve birthweight of infants: a cluster randomised controlled trial in rural Bangladesh
Secondary ID [1] 288357 0
Nil known
Universal Trial Number (UTN)
U1111-1177-7471
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low birthweight 297393 0
Condition category
Condition code
Diet and Nutrition 297544 297544 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 297583 297583 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a cluster randomized controlled trial to test the impact of a home-based practical demonstration using food from the women’s home with nutrition education during pregnancy on the birthweight of the infants. In this regard, a group of pregnant women will be counseled by BRAC's (Bangladesh Rural advancement Committee) community health workers called - 'Shasthya Kormi' about the quantity and quality food appropriate for healthy pregnancy outcome. Shasthya Kormis will visit all pregnant women once in each month and each of them will receive at four to seven sessions of individual counselling based on their availability during the day of home visits. Shasthya Kormis will fill up the antenatal registers during the visits and at the end of the study the numbers of visits will be calculated from the register records. They will practically demonstrate preparation of food plates containing balanced meal (qualitative and quantitatively) made up of readily available food at the household. The intervention will commence in the first trimester (ideally before 12 weeks of gestation) and will continue every month until birth. The sessions will last for ~30-45 minutes.

The primary outcome is the mean difference in birthweight of infants born to mothers in the intervention compared to control groups. All births will be notified within 24 hours and Shasthya Kormis will weigh the infants within 72 hours. Birthweight less than 2500g is considered as low birthweight. The secondary outcome is the maternal dietary behaviour, which includes daily caloric intake and dietary diversity score. Shasthya Kormis will conduct dietary assessments with a semi-structured questionnaire, which will capture detailed information about all foods, beverages and dietary supplements consumed in the past 24 hours with quantity.
Intervention code [1] 293675 0
Treatment: Other
Intervention code [2] 293693 0
Prevention
Comparator / control treatment
The control group will receive standard antenatal care from BRAC and other providers (Government and private) as per regular government protocol which includes advice on; a) taking extra food, b) consumption of meat, fish, liver, egg, milk/milk products, lentils, colorful vegetables, fruits and oil, c) supplementation of iron-folic acid (60 mg iron and 40mg folic acid) and calcium (500mg) tablets.
Control group
Active

Outcomes
Primary outcome [1] 297113 0
Mean birth weight would be the primary outcome of interest. BRAC field supervisory staff Program Organizers will weigh the baby in case of home deliveries. For hospital deliveries, hospital records will be collected.
Timepoint [1] 297113 0
within 72 hours of birth
Secondary outcome [1] 320046 0
Mean daily energy intake would be the 1st secondary outcome. Maternal dietary intake will be measured using food frequency instrument (based on ‘Food and Nutrition Technical Assistance II Project (FANTA-2)).

Timepoint [1] 320046 0
At baseline and at least once in - first trimester (1-3 months), second trimester (4-6 months) and third trimester (7-9 months). Shasthya Kormis collect data during regular antenatal visits, which is once in every month.
Secondary outcome [2] 320047 0
Mean dietary diversity score would be the 2nd secondary outcome of interest. Dietary diversity scores will be calculated by summing up the number of food groups consumed by the individual respondent over the 24-hour recall period.
Timepoint [2] 320047 0
At baseline and at least once in - first trimester (1-3 months), second trimester (4-6 months) and third trimester (7-9 months). Shasthya Kormis collect data during regular antenatal visits, which is once in every month.

Eligibility
Key inclusion criteria
1. Pregnant women
2. Age between 15-49 years
3. First trimester of pregnancy (first 1-3 months)
4. Permanent resident of study area
5. Willing to volunteer
Minimum age
15 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Have plan to deliver outside the study area
2. Diagnosed with chronic diseases like diabetes, hypertension, and other diseases

Study design
Purpose of the study
Educational / counselling / training
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)
In this randomised controlled design intervention will be allocated to the clusters of CHWs. In the study area BRAC has 135 CHWs (Shasthya Kormi), of them 36 has been selected random and proportionately from all five sub-districts. Treatment has been assigned randomly to half (18) of the selected CHWs. Each selected CHWs will enroll 25 pregnant women starting from the date of initiation of the project. Clusters were randomized is two stages by computerized random tables.
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
Sample size and power for the trial was estimated with the following assumptions:
1. The expected mean birth weight in control clusters 2531g
2. The expected difference in mean birthweight between intervention and control groups 100 g (2631g in intervention)
3. The standard deviation 415g
4. Power 80% and 5% two-sided alpha
5. Intra-cluster correlation coefficient (ICC) 0.03
6. The number of clusters 36
Using the standard formulae the sample size required would be 720 from 36 clusters.

Inflating the sample by 5% for non-response, 10% for pregnancy loss and 10% for delivery outside the study area (unpublished data, based on our experience of conducting a large community based trial in rural Bangladesh, we require a sample of 900 pregnant women to retain 720 live births.

All of the women who are randomly assigned to either balanced plate or standard nutrition education will be analysed on an intention to treat basis. We will limit the birthweight data analysis to singleton live born infants. Dietary data will be analysed if we have at least two round of dietary assessment (baseline and follow-up) irrespective of pregnancy outcome. We will use multiple regression analysis to assess intervention effects holding other predictors constant; such as, gestational age, infant sex, parity, age, socioeconomic status education, number of visit and time of first visit after adjusting for cluster (37). To assess the treatment effect on dietary caloric intake and diversity over time, we will use data from each visit distributed across subjects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/10/2016
Date of last participant enrolment
Anticipated
31/12/2016
Actual
31/12/2016
Date of last data collection
Anticipated
30/06/2017
Actual
30/06/2017
Sample size
Target
900
Accrual to date
Final
893
Recruitment outside Australia
Country [1] 7542 0
Bangladesh
State/province [1] 7542 0
Sherpur

Funding & Sponsors
Funding source category [1] 292733 0
University
Name [1] 292733 0
James P Grant School of Public Health, BRAC University
Country [1] 292733 0
Bangladesh
Funding source category [2] 292734 0
University
Name [2] 292734 0
Sydney Medical School, The University of Sydney
Country [2] 292734 0
Australia
Funding source category [3] 292735 0
Other
Name [3] 292735 0
BRAC
Country [3] 292735 0
Bangladesh
Primary sponsor type
Individual
Name
Morseda Chowdhury
Address
School of Public Health
Sydney Medical School
The University of Sydney
Room 124, Edward Ford Building (A27)
NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 291462 0
None
Name [1] 291462 0
Address [1] 291462 0
Country [1] 291462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294219 0
James P Grant School of Public Health, BRAC University Ethical Review Committee
Ethics committee address [1] 294219 0
Ethics committee country [1] 294219 0
Bangladesh
Date submitted for ethics approval [1] 294219 0
13/01/2015
Approval date [1] 294219 0
25/05/2015
Ethics approval number [1] 294219 0
53

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 724 724 0 0
/AnzctrAttachments/369952-Proposal-balanced plate study.docx
Attachments [2] 725 725 0 0
/AnzctrAttachments/369952-approval letter_53.pdf
Attachments [3] 726 726 0 0
/AnzctrAttachments/369952-Dietary assessment questionnaire.doc

Contacts
Principal investigator
Name 62866 0
Dr Morseda Chowdhury
Address 62866 0
School of Public Health, Sydney Medical School
The University of Sydney
Room 124, Edward Ford Building (A27)
NSW 2006, Australia
Country 62866 0
Australia
Phone 62866 0
+61 470 642 799
Fax 62866 0
Email 62866 0
[email protected]
Contact person for public queries
Name 62867 0
Morseda Chowdhury
Address 62867 0
School of Public Health, Sydney Medical School
The University of Sydney
Room 124, Edward Ford Building (A27)
NSW 2006, Australia
Country 62867 0
Australia
Phone 62867 0
+61 470 642 799
Fax 62867 0
Email 62867 0
[email protected]
Contact person for scientific queries
Name 62868 0
Morseda Chowdhury
Address 62868 0
School of Public Health, Sydney Medical School
The University of Sydney
Room 124, Edward Ford Building (A27)
NSW 2006, Australia
Country 62868 0
Australia
Phone 62868 0
+61 470 642 799
Fax 62868 0
Email 62868 0
[email protected]

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