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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03810300
Other study ID # 12835
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2012
Est. completion date May 15, 2018

Study information

Verified date January 2019
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study assesses the sustainability of impacts, 4 years post-program, from a pilot safety net program that was implemented from May 2012-April 2014. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers [north and south]; (2) cash transfers + nutrition behavior communication change (BCC) [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (4) food-cash split [north and south]; and (5) control [north and south]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years.


Description:

The objective of the study is to assess, 4 years after a pilot safety net intervention ended in April 2014, the sustainability of the intervention's impacts on households, children, and women. The intervention, called the Transfer Modality Research Initiative (TMRI), was assigned following a cluster-randomized controlled trial design in two zones of Bangladesh (north and south). WFP-Bangladesh implemented the intervention, and the International Food Policy Research Institute (IFPRI) conducted the impact evaluation research. Intervention arms were assigned at the village level, where arms were as follows: (1) cash transfers [north and south]; (2) cash transfers + nutrition behavior communication change (BCC) [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (5) food-cash split [north and south]; and (5) control [north and south]. Within treatment villages, women living in very poor households were targeted to receive benefits for two years, from May 2012-April 2014. For the original impact evaluation, longitudinal data on 5000 households were collected from 2012-2015 (ClinicalTrials.gov Identifier: NCT02237144).

For the sustainability study in 2018, given available funding, the sampling frame will include 4000 households. This will include all households that were originally in the following arms: (1) cash transfers [north and south]; (2) cash transfers + nutrition BCC [north only]; (3) food transfers [north and south]; (4) food transfers + nutrition BCC [south only]; (5) control [north and south].


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date May 15, 2018
Est. primary completion date May 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria:

- Former participant of Transfer Modality Research Initiative study (in cash, food, cash+BCC, food+BCC, or control arms)

Exclusion Criteria:

Study Design


Intervention

Other:
Cash transfer
1500 taka ($18.75) per household distributed monthly
Food transfer
30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
Food and cash transfer
15 kg of rice, 1 kg of lentils, and 1 kg of micronutrient-fortified cooking oil, and 750 taka cash per household, distributed monthly
Behavioral:
Nutrition behavior Communication Change (BCC)
Weekly, group-based, one-hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings
Other:
Control
No transfer, no behavior change communication

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
International Food Policy Research Institute Cornell University, Data Analysis and Technical Assistance Ltd, World Food Programme, Bangladesh

Outcome

Type Measure Description Time frame Safety issue
Primary Food Consumption Score The Food Consumption Score, as defined by the World Food Programme, is calculated as the number of food groups consumed by the household in the previous 7 days, weighted by each food group's nutritional value and frequency of consumption. Scale range is 0 to 112, with higher values reflecting higher food consumption. After 4 years post-intervention
Primary Child height-for-age z-score Calculated using the 2006 WHO growth reference. This is a continuous measure that represents the number of standard deviations from the mean among comparable children in the WHO growth reference. After 4 years post-intervention
Primary Prevalence of physical intimate partner violence Prevalence of any physical intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument After 4 years post-intervention
Secondary Household dietary diversity Measured by counting the number of food groups consumed by the household After 4 years post-intervention
Secondary 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 in Deaton and Zaidi (2002). Citation: A.Deaton,, and S. Zaidi. 2002. "Guidelines for Constructing Consumption Aggregates for Welfare Analysis." Washington, DC : World Bank. After 4 years post-intervention
Secondary 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 in Deaton and Zaidi (2002). Citation: A.Deaton,, and S. Zaidi. 2002. "Guidelines for Constructing Consumption Aggregates for Welfare Analysis." Washington, DC : World Bank. After 4 years post-intervention
Secondary 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 in Deaton and Zaidi (2002). Citation: A.Deaton,, and S. Zaidi. 2002. "Guidelines for Constructing Consumption Aggregates for Welfare Analysis." Washington, DC : World Bank. After 4 years post-intervention
Secondary Household food insecurity Measured using the Household Food Insecurity Access Scale. Scale range is 0 to 27, with higher values reflecting higher food insecurity. After 4 years post-intervention
Secondary Value of household labor income Value of annual labor income over all household members After 4 years post-intervention
Secondary Value of household non-labor income Value of annual non-labor income over all household members After 4 years post-intervention
Secondary Value of household asset ownership Total value of all assets owned After 4 years post-intervention
Secondary Household land ownership Area of land owned After 4 years post-intervention
Secondary Housing quality: interviews Quality of housing stock. This is measured using a module developed for the study context, and information is collected through household enumerator observation during interviews. After 4 years post-intervention
Secondary Maternal nutrition knowledge score Number answered correctly on a test of maternal knowledge regarding infant and young child feeding practices developed for the survey, based on the curriculum of training sessions in the intervention. After 4 years post-intervention
Secondary Maternal infant and young child feeding practices Maternal adherence to WHO-recommended infant and young child feeding practices After 4 years post-intervention
Secondary Child score on Raven's Progressive Matrices Measured using Raven's Progressive Matrices set A and set B. This is constructed following the test's protocol for scoring. After 4 years post-intervention
Secondary Child score on Early Grade Reading Assessment Measured using Early Grade Reading Assessment adapted to local context. This is constructed following the test's protocol for scoring. After 4 years post-intervention
Secondary Child score on Early Grade Mathematics Assessment Measured using Early Grade Mathematics Assessment adapted to local context. This is constructed following the test's protocol for scoring. After 4 years post-intervention
Secondary Child score on Strengths and Difficulties Questionnaire Measured using Strengths and Difficulties Questionnaire, part of the Development and Well-Being Assessment family of mental heath measures. This is constructed following the test's protocol for scoring. After 4 years post-intervention
Secondary Child weight-for-height z-score Calculated using the 2006 WHO growth reference. This is a continuous measure that represents the number of standard deviations from the mean among comparable children in the WHO growth reference. After 4 years post-intervention
Secondary Prevalence of child stunting Calculated using the 2006 WHO growth reference After 4 years post-intervention
Secondary Prevalence of child wasting Calculated using the 2006 WHO growth reference After 4 years post-intervention
Secondary Child illness Mother's report of child illness in previous 2 weeks After 4 years post-intervention
Secondary Parental interaction with child Time spent on child stimulation activities in previous 7 days, measured using modules developed for the survey After 4 years post-intervention
Secondary Parental discipline of the child Disciplinary measures used in the past month, measured using modules developed for the survey After 4 years post-intervention
Secondary Community norms on gender Community leaders' attitudes toward gender, measured using modules developed for the survey After 4 years post-intervention
Secondary Prevalence of emotional violence Prevalence of any emotional intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument After 4 years post-intervention
Secondary Prevalence of controlling behaviors Prevalence of any controlling behaviors in the past 12 months measured using the WHO Violence Against Women instrument After 4 years post-intervention
Secondary Prevalence of individual acts of intimate partner violence Prevalence of individual acts of intimate partner violence in the past 12 months measured using the WHO Violence Against Women instrument After 4 years post-intervention
Secondary Individual decisionmaking Measured using men's and women's decisionmaking modules adapted from pro-WEAI After 4 years post-intervention
Secondary Individual asset ownership Measured using men's and women's asset ownership modules developed for the survey After 4 years post-intervention
Secondary Individual mobility Measured using men's and women's mobility modules adapted from pro-WEAI After 4 years post-intervention
Secondary Individual labor force participation Measured using men's and women's labor modules developed for the survey After 4 years post-intervention
Secondary Individual attitudes toward gender and intimate partner violence Measured using men's and women's attitudes toward gender and intimate partner violence modules developed for the survey After 4 years post-intervention
Secondary Individual social capital Measured using men's and women's social capital modules developed for the survey After 4 years post-intervention
Secondary Individual stress Measured using men's and women's Perceived Stress Scale scores After 4 years post-intervention
Secondary Individual depression Measured using men's and women's Patient Health Questionnaire-9 Depression Test scores After 4 years post-intervention
Secondary Individual aspirations Measured using men's and women's aspirations modules developed for the survey After 4 years post-intervention
Secondary Spousal relationship Measured using men's and women's relationship modules developed for the survey After 4 years post-intervention
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