Birth WeightNCT05855551
Improving Birth Outcomes in Bangladesh
A study testing Base cash transfer, Behavior change communication (BCC) and Food basket in people with Birth Weight and Small for Gestational Age at Delivery, run by International Food Policy Research Institute at 1 site in Bangladesh.
Trial summary
Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight, Small for Gestational Age at Delivery, Diet; Deficiency
- What is being tested?
- Base cash transfer, Behavior change communication (BCC) and Food basket
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,620 participants
- Where
- 1 siteBangladesh
- Study dates
- 25 May 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant with their first or second child (in case of death of the first or second child during pregnancy or within two years of birth, the mother will be eligible during her third pregnancy);
- In possession of a valid NID (or a NID application acknowledgement).
- Meeting the eligibility criteria of the Government of Bangladesh' Mother and Child Benefit Programme (MCBP)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joint Interventions to Improve Birth Outcomes and Nutrition in Bangladesh: the Jibon Trial
Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh.
Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant.
A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.
- Conditions
- Birth Weight, Small for Gestational Age at Delivery, Diet; Deficiency, Gestational Weight Gain
- Being tested
- Base cash transfer, Behavior change communication (BCC), Food basket, Top-up cash
- Medical subject headings
- Birth Weight, Malnutrition, Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base cash transferOther
Program beneficiaries will receive a monthly transfer of 800 BDT. A government-to-person (G2P) payment system will be used, which will transfer cash on a monthly basis. Under this new system, beneficiaries will select one of the following payment channels based on convenience: mobile financial services or through a bank transfer (which women in remote areas could access through agent banking). Each month, women will receive a text message from the government informing her that the money has been credited to her account.
Behavior change communication (BCC)Behavioural
The BCC strategy has two different components:
- Monthly courtyard meetings: Courtyard sessions (12 to 15 women) will be organized at a place no more than 15 to 20 minutes walking distance from the beneficiary's home. Family members (husband, mother-in-law, …) are invited to join the meeting. Sessions are part of a continuous 4-session cycle. Each session will lasts 1.5 hours and will use different didactic methods. Topics include pregnancy nutrition and care, breastfeeding, importance of different micronutrients, and nutrition and care during lactation. The importance of a healthy diet during pregnancy is repeated in each session. Pregnant women receive a take-home poster that summarizes how to eat a healthy diet during pregnancy.
- Home visits: Visits will cover the content of any sessions missed by pregnant women and will reinforce the messages regarding maternal diet on the take-home poster.
Food basketOther
The monthly food basket will provide 10 kg micronutrient fortified rice , 3.5 kg of lentils, and 1000 ml of oil, valued at 800 BDT . Assuming a the ration is split equally among the 5 members of an average-sized household in rural Bangladesh and using food composition data for Bangladesh, the food basket is estimated to provide 354 kcal and 11 g of protein per person per day. The food basket will be provided once every month.
The individually packaged foods will be distributed at the Union parishad office, community clinic, or another government facility in the first week of each month. The UDW will inform the beneficiaries of the place and time of the food distribution. Recipients will only receive the food when they present their food card. The card will also be used to record receipt of each ration. If beneficiaries cannot attend the food distribution themselves, a designated "nominee" can pick up the ration on their behalf.
Top-up cashOther
The monthly top-up cash of 1,000 BDT will be added to the "base" amount that is part of the standard program. For the top-up cash transfer, a person-to-person payment system is used. WFP will contract with one popular mobile banking service (either bKash or Rockets) for the monthly top-up cash transfers. About two weeks after receiving the base cash transfer, women will receive the top-up cash through a mobile account (which can also be used to receive the base cash transfer). A text message will be sent to the beneficiary to inform her that the top-up transfer has been made into her account.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - base cash + BCC | Experimental | pregnant women in this arm will receive the standard package (800 BDT each month), and in addition intensive group-based BCC on nutrition with a focus on how to improve their dietary intake during pregnancy Receives: Other: Base cash transfer; Behavioral: Behavior change communication (BCC) |
| Arm 2 - base cash + BCC + food | Experimental | pregnant women in this arm will receive the standard package (i.e., arm 1) and in addition a monthly food basket. The monthly food basket will provide 10 kg micronutrient fortified rice, 3.5 kg of lentils, and 1000 ml of oil, valued at 1000 BDT. Receives: Other: Base cash transfer; Behavioral: Behavior change communication (BCC); Other: Food basket |
| Arm 3 - base cash + BCC + top-up cash | Experimental | pregnant women in this arm will receive the standard package (i.e., arm 1) and in addition a monthly top-up cash of 1000 BDT to be added to the "base" amount that is part of the standard program. Receives: Other: Base cash transfer; Behavioral: Behavior change communication (BCC); Other: Top-up cash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weekly weight gain 2nd to 3rd trimester
Women's weekly weight gain will be calculated by differencing women's weight obtained in the second and third trimester and dividing by the number of weeks between both measurements.
Measured: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Total gestational weight gain by the third trimester
Total weight gain will be calculated by calculating the difference between women's third trimester weight and the weight obtained at the time of the census.
Measured: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Dietary energy intake and proportion of women below 85% of the estimate energy requirement (EER)
Dietary energy intake will be assessed using a 24-hour recall in the second and third trimester (18). EER will be calculated using each woman's basal metabolic rate (estimated from the woman's age, gender, and current weight), level of physical activity, and pregnancy trimester. Factors of 1.4 for low, 1.7 for moderate, and 2.0 for high physical activity will be used (19). Additional energy requirement for the second and third trimester of pregnancy (340-350 kcal/d and 452-500 kcal/d, respectively, depending on which reference will be used (20,21)) will be added to account for gestational weight gain and increases in basal metabolic rate.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Dietary protein intake
The 24-hour recall data will be used to assess women's protein intake.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Mean probability of micronutrient adequacy
the mean of the probabilities of adequacy for 11 key micronutrients (iron, calcium, zinc, vitamin A, thiamin, riboflavin, niacin, vitamin B-6, vitamin B-12, vitamin C, and folate) will be calculated using the 24h recall data. The estimated usual intake will be used to calculate the probability that the usual intake was above the EAR during pregnancy (25).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Length of gestation
The difference between the date of birth and the first day of the last menstrual period (assessed in the first survey) will be used to calculate length of gestation.
Measured: Delivery
Preterm birth
Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation.
Measured: Delivery
Prevalence of emotional violence towards the pregnant woman/mother of the newborn child
Prevalence of any emotional intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of controlling behaviors towards the pregnant woman/mother of the newborn child
Prevalence of any controlling behaviors in the past 6 months measured using the WHO Violence Against Women instrument (26).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of physical violence towards the pregnant woman/mother of the newborn child
Prevalence of any physical intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Stress of the pregnant woman/mother of the newborn child
Measured using women's Perceived Stress Scale score
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Maternal-fetal attachment
Maternal attachment to their unborn child will be assessed during their 3rd trimester of pregnancy using the Prenatal Attachment Inventory
Measured: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Maternal-infant attachment
Maternal attachment to their infant will be assessed at 2 months (i.e., 61 days) postpartum using the Postpartum Bonding Questionnaire
Measured: Two months post-partum (61 d ± 1 wk)
Stress of the husband of the pregnant woman
Measured using men's Perceived Stress Scale score (27).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Birthweight
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life.
Measured: Within 72 hours post partum
Low birthweight
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life. Low birthweight will be defined as a weight below 2500g.
Measured: Within 72 hours post partum
Household food security
The Household Food Insecurity Access Scale will be used to measure household food security status.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Value of total household consumption
Aggregate value of household food and non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Value of household food consumption
Value of household food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Secondary outcomes (30)
Gestational weekly weight gain up to the 2nd trimester
Women's weekly weight gain will be calculated by differencing women's weight obtained at the census (before pregnancy) and second trimester and dividing by gestational age in weeks.
Measured: Second pregnancy trimester
Use of iron-folic acid, calcium, vitamin B complex, and multiple micronutrient supplements
Women will be asked to report on their use of these supplements during pregnancy.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Antenatal care utilization by the pregnant woman
Antenatal care utilization will be assessed with respect to current recommendations in Bangladesh and with respect to the new WHO guidelines
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Prenatal nutrition knowledge of the pregnant woman
Women's knowledge related to nutrition will be assessed using a set of questions developed for this study.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Post natal care utilization by the mother of the newborn child
Postnatal care utilization will be assessed
Measured: Two months post-partum (61 d ± 1 wk)
Postpartum weight
We will measure women's weight at the 2-month postpartum visit.
Measured: Two months post-partum (61 d ± 1 wk)
Spousal relationship between the pregnant woman/mother of the newborn child and her husband
Measured using women's spousal relationship modules developed for the survey.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Decisionmaking by the pregnant woman/mother of the newborn child
Measured using women's decision-making modules adapted from pro-WEAI (34).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Mobility of the pregnant woman
Measured using mobility modules adapted from pro-WEAI (34).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Labor force participation of the pregnant woman
Measured using women's labor modules developed for the survey.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Attitudes toward gender and intimate partner violence of the pregnant woman
Measured using women's attitudes toward gender and intimate partner violence modules developed for the survey.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Social capital of the pregnant woman
Measured using modules on women's social interactions and perceptions of neighborhood responses to intimate partner violence, developed for the survey.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Agency of the pregnant woman
Measured using women's responses on locus of control (35).
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of individual acts of intimate partner violence towards the pregnant woman/mother of the newborn child
Prevalence of individual acts of intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Institutional delivery
We will ask if the baby was delivered in a health facility
Measured: Within 72 hours post partum
Skilled attendance at birth
Women will be asked if a skilled birth attended the birth of the child
Measured: Within 72 hours post partum
Caesarian section
Women will be asked if a c-section was used to deliver the child
Measured: Within 72 hours post partum
Prenatal nutrition knowledge of the husband of the pregnant woman
Using a similar approach as that use for pregnant women, husband's nutrition knowledge.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Husband's weight
Weight of the husband will be assessed.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Birth length
The length of the newborn will be assessed at the time of the birthweight assessment.
Measured: Within 72 hours post partum
Infant length and weight
Length and weight at 2 mo postpartum
Measured: Two months post-partum (61 d ± 1 wk)
Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birth
Women will be asked whether and how they breastfeed their newborn child. We will also assess if other liquids are provided to the child (36).
Measured: Within 72 hours post partum
(Exclusive) breastfeeding and infant feeding practices at 2 months
women will be asked whether and how they breastfeed their newborn child. We will also assess if other liquids and solid foods are provided to the child (36).
Measured: Two months post-partum (61 d ± 1 wk)
Neonatal and infant mortality
neonatal (within the first 1 month after birth) and infant (within the first 2 months after birth) mortality will be assessed through parental recall at the 2-month postpartum visit.
Measured: One and two months post-partum
Value of household non-food consumption
Value of household non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32). The third-trimester assessment will be used to assess impact.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Housing quality
Quality of housing stock, measured using a module developed for the study context and collected through household enumerator observation during interviews.
Measured: Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
Household asset ownership
Index of household asset ownership, measured using a module developed for the study context.
Measured: Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
Household income from remittances
Measured with a module on income (Taka) from remittances received from relatives outside and within the country. The third-trimester assessment will be used to assess impact
Measured: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Household savings
A continuous measure on total household savings, calculated using reported savings of each household member 15 years of age or older.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Household loans
A continuous measure on household loans, calculated using reported amounts of loans taken and outstanding amounts owed for each household member 15 years of age or older.
Measured: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start25 May 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Jef Leroy, PhD, Principal investigator, International Food Policy Research InstituteShalini Roy, PhD, Principal investigator, International Food Policy Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855551
- Sponsor's protocol ID
- PHND-Jibon
- Status last verified
- Nov 2024
- First submitted
- 16 Feb 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of primary data analyses
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Interventions to Improve Birth Outcomes and Nutrition in Bangladesh: the Jibon Trial
- ClinicalTrials.gov ID
- NCT05855551
- Acronym / sponsor ID
- PHND-Jibon
- Conditions
- Birth Weight, Small for Gestational Age at Delivery, Diet; Deficiency, Gestational Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,620 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 25 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh.
Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant.
A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - base cash + BCC | Experimental | Other: Base cash transfer, Behavioral: Behavior change communication (BCC)pregnant women in this arm will receive the standard package (800 BDT each month), and in addition intensive group-based BCC on nutrition with a focus on how to improve their dietary intake during pregnancy |
| Arm 2 - base cash + BCC + food | Experimental | Other: Base cash transfer, Behavioral: Behavior change communication (BCC), Other: Food basketpregnant women in this arm will receive the standard package (i.e., arm 1) and in addition a monthly food basket. The monthly food basket will provide 10 kg micronutrient fortified rice, 3.5 kg of lentils, and 1000 ml of oil, valued at 1000 BDT. |
| Arm 3 - base cash + BCC + top-up cash | Experimental | Other: Base cash transfer, Behavioral: Behavior change communication (BCC), Other: Top-up cashpregnant women in this arm will receive the standard package (i.e., arm 1) and in addition a monthly top-up cash of 1000 BDT to be added to the "base" amount that is part of the standard program. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant with their first or second child (in case of death of the first or second child during pregnancy or within two years of birth, the mother will be eligible during her third pregnancy);
- In possession of a valid NID (or a NID application acknowledgement).
- Meeting the eligibility criteria of the Government of Bangladesh' Mother and Child Benefit Programme (MCBP)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Base cash transferProgram beneficiaries will receive a monthly transfer of 800 BDT. A government-to-person (G2P) payment system will be used, which will transfer cash on a monthly basis. Under this new system, beneficiaries will select one of the following payment channels based on convenience: mobile financial services or through a bank transfer (which women in remote areas could access through agent banking). Each month, women will receive a text message from the government informing her that the money has been credited to her account. | Other | Arm 1 - base cash + BCC, Arm 2 - base cash + BCC + food, Arm 3 - base cash + BCC + top-up cash |
| Behavior change communication (BCC)The BCC strategy has two different components: * Monthly courtyard meetings: Courtyard sessions (12 to 15 women) will be organized at a place no more than 15 to 20 minutes walking distance from the beneficiary's home. Family members (husband, mother-in-law, …) are invited to join the meeting. Sessions are part of a continuous 4-session cycle. Each session will lasts 1.5 hours and will use different didactic methods. Topics include pregnancy nutrition and care, breastfeeding, importance of different micronutrients, and nutrition and care during lactation. The importance of a healthy diet during pregnancy is repeated in each session. Pregnant women receive a take-home poster that summarizes how to eat a healthy diet during pregnancy. * Home visits: Visits will cover the content of any sessions missed by pregnant women and will reinforce the messages regarding maternal diet on the take-home poster. | Behavioural | Arm 1 - base cash + BCC, Arm 2 - base cash + BCC + food, Arm 3 - base cash + BCC + top-up cash |
| Food basketThe monthly food basket will provide 10 kg micronutrient fortified rice , 3.5 kg of lentils, and 1000 ml of oil, valued at 800 BDT . Assuming a the ration is split equally among the 5 members of an average-sized household in rural Bangladesh and using food composition data for Bangladesh, the food basket is estimated to provide 354 kcal and 11 g of protein per person per day. The food basket will be provided once every month. The individually packaged foods will be distributed at the Union parishad office, community clinic, or another government facility in the first week of each month. The UDW will inform the beneficiaries of the place and time of the food distribution. Recipients will only receive the food when they present their food card. The card will also be used to record receipt of each ration. If beneficiaries cannot attend the food distribution themselves, a designated "nominee" can pick up the ration on their behalf. | Other | Arm 2 - base cash + BCC + food |
| Top-up cashThe monthly top-up cash of 1,000 BDT will be added to the "base" amount that is part of the standard program. For the top-up cash transfer, a person-to-person payment system is used. WFP will contract with one popular mobile banking service (either bKash or Rockets) for the monthly top-up cash transfers. About two weeks after receiving the base cash transfer, women will receive the top-up cash through a mobile account (which can also be used to receive the base cash transfer). A text message will be sent to the beneficiary to inform her that the top-up transfer has been made into her account. | Other | Arm 3 - base cash + BCC + top-up cash |
Primary outcome
Gestational weekly weight gain 2nd to 3rd trimester
Time frame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Women's weekly weight gain will be calculated by differencing women's weight obtained in the second and third trimester and dividing by the number of weeks between both measurements.
Total gestational weight gain by the third trimester
Time frame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Total weight gain will be calculated by calculating the difference between women's third trimester weight and the weight obtained at the time of the census.
Dietary energy intake and proportion of women below 85% of the estimate energy requirement (EER)
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Dietary energy intake will be assessed using a 24-hour recall in the second and third trimester (18). EER will be calculated using each woman's basal metabolic rate (estimated from the woman's age, gender, and current weight), level of physical activity, and pregnancy trimester. Factors of 1.4 for low, 1.7 for moderate, and 2.0 for high physical activity will be used (19). Additional energy requirement for the second and third trimester of pregnancy (340-350 kcal/d and 452-500 kcal/d, respectively, depending on which reference will be used (20,21)) will be added to account for gestational weight gain and increases in basal metabolic rate.
Dietary protein intake
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
The 24-hour recall data will be used to assess women's protein intake.
Mean probability of micronutrient adequacy
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
the mean of the probabilities of adequacy for 11 key micronutrients (iron, calcium, zinc, vitamin A, thiamin, riboflavin, niacin, vitamin B-6, vitamin B-12, vitamin C, and folate) will be calculated using the 24h recall data. The estimated usual intake will be used to calculate the probability that the usual intake was above the EAR during pregnancy (25).
Length of gestation
Time frame: Delivery
The difference between the date of birth and the first day of the last menstrual period (assessed in the first survey) will be used to calculate length of gestation.
Preterm birth
Time frame: Delivery
Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation.
Prevalence of emotional violence towards the pregnant woman/mother of the newborn child
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of any emotional intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Prevalence of controlling behaviors towards the pregnant woman/mother of the newborn child
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of any controlling behaviors in the past 6 months measured using the WHO Violence Against Women instrument (26).
Prevalence of physical violence towards the pregnant woman/mother of the newborn child
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of any physical intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Stress of the pregnant woman/mother of the newborn child
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Measured using women's Perceived Stress Scale score
Maternal-fetal attachment
Time frame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Maternal attachment to their unborn child will be assessed during their 3rd trimester of pregnancy using the Prenatal Attachment Inventory
Maternal-infant attachment
Time frame: Two months post-partum (61 d ± 1 wk)
Maternal attachment to their infant will be assessed at 2 months (i.e., 61 days) postpartum using the Postpartum Bonding Questionnaire
Stress of the husband of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Measured using men's Perceived Stress Scale score (27).
Birthweight
Time frame: Within 72 hours post partum
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life.
Low birthweight
Time frame: Within 72 hours post partum
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life. Low birthweight will be defined as a weight below 2500g.
Household food security
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
The Household Food Insecurity Access Scale will be used to measure household food security status.
Value of total household consumption
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Aggregate value of household food and non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
Value of household food consumption
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Value of household food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
30 secondary outcomes
Gestational weekly weight gain up to the 2nd trimester
Time frame: Second pregnancy trimester
Use of iron-folic acid, calcium, vitamin B complex, and multiple micronutrient supplements
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Antenatal care utilization by the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Prenatal nutrition knowledge of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Post natal care utilization by the mother of the newborn child
Time frame: Two months post-partum (61 d ± 1 wk)
Postpartum weight
Time frame: Two months post-partum (61 d ± 1 wk)
Spousal relationship between the pregnant woman/mother of the newborn child and her husband
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Decisionmaking by the pregnant woman/mother of the newborn child
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Mobility of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Labor force participation of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Attitudes toward gender and intimate partner violence of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Social capital of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Agency of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Prevalence of individual acts of intimate partner violence towards the pregnant woman/mother of the newborn child
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Institutional delivery
Time frame: Within 72 hours post partum
Skilled attendance at birth
Time frame: Within 72 hours post partum
Caesarian section
Time frame: Within 72 hours post partum
Prenatal nutrition knowledge of the husband of the pregnant woman
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Husband's weight
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Birth length
Time frame: Within 72 hours post partum
Infant length and weight
Time frame: Two months post-partum (61 d ± 1 wk)
Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birth
Time frame: Within 72 hours post partum
(Exclusive) breastfeeding and infant feeding practices at 2 months
Time frame: Two months post-partum (61 d ± 1 wk)
Neonatal and infant mortality
Time frame: One and two months post-partum
Value of household non-food consumption
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Housing quality
Time frame: Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
Household asset ownership
Time frame: Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
Household income from remittances
Time frame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
Household savings
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Household loans
Time frame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Yes. Upon completion of primary data analyses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jef Leroy, PhD principal investigator
International Food Policy Research Institute
Shalini Roy, PhD principal investigator
International Food Policy Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Base cash transfer, Behavior change communication (BCC) and Food basket in people with Birth Weight and Small for Gestational Age at Delivery, run by International Food Policy Research Institute at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational weekly weight gain 2nd to 3rd trimester (time frame: Third pregnancy trimester (34 ± 1 wk of pregnancy)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.