Promotion of a balanced diet for pregnant women to improve birthweight of infants: a cluster randomised controlled trial in rural Bangladesh

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000080426
• Date of registration: 25/01/2016
• Prospective Registration: Yes
• Primary sponsor: Morseda Chowdhury
• 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
• Date of first enrolment: 01/10/2016
• Target sample size: 900
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000080426.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Bangladesh

Contacts

• Name: Dr Morseda Chowdhury

• Name: Dr Morseda Chowdhury

Key inclusion & exclusion criteria

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

Exclusion criteria: 1. Have plan to deliver outside the study area
2. Diagnosed with chronic diseases like diabetes, hypertension, and other diseases


Age minimum: 15 Years
Age maximum: 49 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Antenatal care

Low birthweight;
Low birthweight

Diet and Nutrition - Other diet and nutrition disorders

Intervention(s)

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 cons

Primary Outcome(s)

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. [within 72 hours of birth]

Secondary Outcome(s)

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)).

[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. ]

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.[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 ID(s)

Nil known

Source(s) of Monetary Support

Sydney Medical School, The University of Sydney

BRAC

James P Grant School of Public Health, BRAC University

Ethics review

Status: Approved
Approval date:
Contact:

James P Grant School of Public Health, BRAC University Ethical Review Committee