Clinical trial NCT02597608: Impact Evaluation of the DFID Programme to Accelerate Improved Nutrition of the Extreme Poor in Bangladesh
Official title: Impact Evaluation of the DFID Programme to Accelerate Improved Nutrition of the Extreme Poor in Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutritional Status
Household Dietary Diversity
Maternal Nutrition Knowledge and Practices
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Department for International Development, United Kingdom
name: Institute of Development Studies
name: Chars Livelihoods Programme
name: Shiree, Stimulating Household Improvements Resulting in Economic Empowerment
name: Urban Partnerships for Poverty Reduction
name: Consortium of International Agricultural Research Centers
First posted: 2015-11-05
Enrollment: 11340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a randomized study in three areas of Bangladesh (Chars region where CLP operates, Haor region where Shiree operates, and urban slums where UPPR operates). Treatment is assigned at the community level, where treatments are:

* Livelihoods intervention only (L only)
* Livelihoods intervention plus nutrition intervention (L+N)

In UPPR only, the study also includes a non-randomly selected comparison group (C).

Within treatment localities, targeted beneficiaries include women, adolescent girls, and children under 24 months. Benefits are received for two years.

Detailed description: Undernutrition is widespread in Bangladesh. In 2011, according to the Bangladesh Demographic and Health Survey, 41.3 per cent of children under age five were stunted, 36.4 per cent were underweight, 15.6 per cent were wasted, and more than 50 per cent were anaemic. Prevalences were even higher among extremely poor households. Meanwhile, evidence from South Asia shows that high rates of economic growth and reduction in poverty have not led to similarly large reductions in undernutrition (see 1, 2, 3). These findings have suggested that improvements in income alone may not be sufficient to improve nutritional status. Extensive research has also shown that the critical window for nutritional interventions is during the "first thousand days" of life (see 4, 5), from the time when a child is in utero until about two years of age. Based on this accumulated evidence, growing attention has come to introducing nutrition interventions that target children's "first thousand days" alongside household poverty reduction programmes. In particular, there has been growing emphasis on nutrition interventions that aim to improve infant and young child feeding practices-through increasing nutritional knowledge of women who are pregnant, lactating, or likely to be pregnant in the future-as well as to improve the nutritional status of these women themselves.

Although there exists considerable evidence assessing the effectiveness of various livelihoods interventions and other social protection programmes, as well as some evidence on the effectiveness of various direct nutritional interventions, little research directly assesses how an integrated livelihoods and nutrition programme might compare with livelihoods support alone. There are several reasons why the combination of nutrition and livelihoods support may have nutritional benefits over and above livelihoods support only. First, a key constraint to improved nutritional status may be insufficient knowledge of appropriate infant and young child feeding practices (for example, the appropriate duration of exclusive breastfeeding, the appropriate frequency and diversity of child feeding thereafter, etc.). If this is the case, then improving income alone will not necessarily lead to improved feeding practices. Second, there may be synergies between the two types of support. For example, even if a mother's knowledge of infant and young child feeding practices improves, she may still need access to sufficient resources for undertaking those practices (such as income to purchase the recommended types of food), which can be facilitated through a livelihoods intervention. Third, there may be other dynamics shifted through the direct nutrition intervention that mediate how the livelihoods intervention affects nutritional status. For example, if a direct nutrition intervention targeting women improves women's bargaining power within the household, and if women tend to prefer devoting more resources to young children's nutrition (e.g., Quisumbing and Maluccio 2003), the result may also be larger impacts on nutritional status than livelihoods support alone.

The DFID Programme to Accelerate Improved Nutrition for the Extreme Poor in Bangladesh aims to improve nutrition outcomes for young children, pregnant and lactating mothers, and adolescent girls. Its approach is to integrate direct nutrition interventions into the livelihood support currently provided to extremely poor households in Bangladesh through three existing programmes: the Chars Livelihoods Programme (CLP), the Shiree Economic Empowerment of the Poorest Programme (Shiree or EEP, within which the investigators focus on the Concern subproject), and the Urban Partnership for Poverty Reduction Programme (UPPR).

In order to rigorously and independently assess the impacts of these integrated nutrition and livelihoods programmes, DFID has collaborated with research partners and implementation partners to undertake a mixed methods impact evaluation, entitled "Impact Evaluation of the DFID Programme to Accelerate Improved Nutrition for the Extreme Poor in Bangladesh." The evaluation team includes IDS (the lead organisation), IFPRI, ITAD, CNRS, and BRAC University. The evaluation uses mixed quantitative and qualitative methods within a strong theory-based design to assess the impacts of the integrated programmes on nutritional status.

The quantitative impact component involves a baseline survey (conducted in September-November 2013) and an endline survey (to be conducted in November-December 2015). The exploratory/explanatory component includes a qualitative subcomponent (for which the first phase of fieldwork has been ongoing since February 2014), as well as a process evaluation subcomponent (ongoing since July 2014, final results not yet available). The cost effectiveness component began in August 2014 and will be completed in early 2016 following the quantitative endline survey completion.

The three key research questions regarding programme impact that will be addressed are:

1. What is the impact on nutrition outcomes of receiving a combination of livelihoods and direct nutrition interventions (denoting this scenario (L+N)), relative to receiving a livelihoods intervention only (denoting this scenario (L))?
2. What is the impact on nutrition outcomes of receiving a combination of livelihoods and direct nutrition interventions (L+N), relative to receiving no intervention (denoting this scenario (C) for control)?
3. What is the impact on nutrition outcomes of receiving a livelihoods intervention only (L), relative to receiving no intervention (C)? This will pertain only to the urban group served by UPPR.

In order to construct a proxy for the (L+N) households in the counterfactual (L) scenario, randomisation is used. Among the households that already receive the livelihoods intervention at baseline, half are randomly assigned to additionally receive the nutrition intervention after the baseline (denoted the (L+N) group). The remaining half continue to receive only the livelihoods intervention (denoting the (L) group). Randomisation is conducted at the level of primary sampling units (PSUs) that cover an entire locality, rather than at the level of individual households. The randomisation makes it very likely that characteristics of the (L) and (L+N) groups will on average be similar at baseline. (L) is then a valid proxy for (L+N), and average differences between the groups at endline can be interpreted as impacts caused only by the addition of the nutrition component rather than pre-existing differences.

In order to construct a proxy for the (L+N) households in the counterfactual (C) scenario of no intervention, non-randomised approaches are used. Since none of the original livelihoods interventions was rolled out following a randomised control trial design, there is no obvious set of comparable non-beneficiaries to serve as the counterfactual. Because a control group is nonetheless required to assess the absolute benefits of either (L) or (L + N) interventions, attempts were made to construct the best possible control group out of non-randomly selected non-beneficiaries. It is important to emphasise that a non-random control group is not expected to be on average identical to beneficiary households. In the baseline survey, the objective was simply to sample a group of non-beneficiaries as similar as possible to the beneficiaries except for receipt of the intervention.

Major topics areas covered by the qualitative data collection tools include the following:

1. Social, economic, institutional and political context of the community
2. Local practices, resources, customs in regards to health, hygiene, nutrition and care of children, pregnant and lactation mothers, adolescent girls
3. For (L) and (L+N) sites: Perceived impact of the livelihood intervention
4. For (L+N) sites: Perceived synergies and disconnects between the nutrition and livelihood interventions in the communities
5. For (L+N) sites: Micro-dynamics of the nutrition intervention at the community level and how beneficiaries perceive/experience the intervention

Eligibility criteria: Inclusion Criteria:

* Children (boys and girls) 0-36 months
* Pregnant and breastfeeding women
* Adolescent girls (aged 13-19)
* Households must meet eligibility criteria of each of the three programmes (CLP, Shiree, UPPR) except for the control group in UPPR.

Exclusion Criteria:

* None

Primary outcomes:
measure: Child anthropometry - height for age
timeFrame: Baseline. Up to 24 months.
measure: Child food intake - number unique foods
timeFrame: Baseline. Up to 24 months.
measure: Dietary diversity of index child's mother, father, and of adolescent girl - unique foods
timeFrame: Baseline. Up to 24 months.
measure: Index child mother's nutrition knowledge
timeFrame: Baseline. Up to 24 months.
measure: Household food security - food groups
timeFrame: Baseline. Up to 24 months.
measure: Infant and young child feeding practices - breastfeeding
timeFrame: Baseline. Up to 24 months.
measure: Receipt of and participation in livelihoods and nutrition interventions (take up)
timeFrame: Baseline. Up to 24 months.
measure: Community nutrition worker knowledge and activities.
timeFrame: Up to 24 months.
measure: Child anthropometry - weight for age
timeFrame: Baseline. Up to 24 months.
measure: Child anthropometry - stunting
timeFrame: Baseline. Up to 24 months.
measure: Child anthropometry - wasting
timeFrame: Baseline. Up to 24 months.
measure: Child food intake - number food groups
timeFrame: Baseline. Up to 24 months.
measure: Child food intake - food groups
timeFrame: Baseline. Up to 24 months
measure: Child food intake - caloric consumption
timeFrame: Baseline. Up to 24 months.
measure: Dietary diversity of index child's mother, father, and of adolescent girl
timeFrame: Baseline. Up to 24 months.
measure: Household food security - unique foods
timeFrame: Baseline. Up to 24 months.
measure: Household food security - number of food groups
timeFrame: Baseline. Up to 24 months.
measure: Household food security - value of consumption
timeFrame: Baseline. Up to 24 months.
measure: Household food security - caloric availability
timeFrame: Baseline. Up to 24 months.
measure: Infant and young child feeding practices - complementary feeding
timeFrame: Baseline. Up to 24 months.
measure: Community nutrition worker knowledge and activities
timeFrame: Up to 24 months.
measure: Child anthropometry - weight for height
timeFrame: Baseline. Up to 24 months.
measure: Women's BMI
timeFrame: Baseline. Up to 24 months.
Secondary outcomes:
measure: Nutrition knowledge of adolescent girl
timeFrame: Baseline. Up to 24 months.
measure: Health of index child <36 months - child ill
timeFrame: Baseline. Up to 24 months.
measure: Antenatal care - attendance
timeFrame: Baseline. Up to 24 months.
measure: Sanitation practices for index child
timeFrame: Baseline. Up to 24 months.
measure: Women's status index
timeFrame: Baseline. Up to 24 months.
measure: Ownership of assets - value
timeFrame: Baseline. Up to 24 months.
measure: Housing quality
timeFrame: Baseline. Up to 24 months.
measure: Household consumption - food consumption
timeFrame: Baseline. Up to 24 months.
measure: Household income
timeFrame: Baseline. Up to 24 months.
measure: Health of index child <36 months - care sought
timeFrame: Baseline. Up to 24 months.
measure: Health of index child < 36 months - where care received
timeFrame: Baseline. Up to 24 months.
measure: Antenatal care
timeFrame: Baseline. Up to 24 months.
measure: Care at birth
timeFrame: Baseline. Up to 24 months.
measure: Household consumption - value of non-food consumption
timeFrame: Baseline. Up to 24 months.
measure: Household consumption - value of non-food consumption subgroups
timeFrame: Baseline. Up to 24 months.
measure: Household consumption - food and non-food
timeFrame: Baseline. Up to 24 months.
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Food Policy Research Institute
Study officials:
affiliation: Cornell University
name: John Hoddinott, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Shalini Roy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Naureen Karachiwalla, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dhaka
name: Firdousi Naher, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Development Studies, University of Sussex
name: Nick Nisbett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Development Studies, University of Sussex
name: Jean Pierre Tranchant, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith, L. C., U. Ramakrishnan, A. Ndiaye, L. Haddad, and R. Martorell. 2002. "The Asian Engima. Chapter 7 of The Importance of Women's Status for Child Nutrition in Developing Countries. Research Report 131. Washington, DC: International Food Policy Research Institute.
citation: Ramalingaswami, V., U. Jonsson, and J. Rohde. 1996. "Commentary: The Asian Enigma." In The Progress of Nations. New York: UNICEF.
citation: Deaton, A., and J. Dreze. 2009.
citation: Bhutta ZA, Das JK, Rizvi A, Gaffey MF, Walker N, Horton S, Webb P, Lartey A, Black RE; Lancet Nutrition Interventions Review Group, the Maternal and Child Nutrition Study Group. Evidence-based interventions for improvement of maternal and child nutrition: what can be done and at what cost? Lancet. 2013 Aug 3;382(9890):452-477. doi: 10.1016/S0140-6736(13)60996-4. Epub 2013 Jun 6.
citation: Hoddinott J, Behrman JR, Maluccio JA, Melgar P, Quisumbing AR, Ramirez-Zea M, Stein AD, Yount KM, Martorell R. Adult consequences of growth failure in early childhood. Am J Clin Nutr. 2013 Nov;98(5):1170-8. doi: 10.3945/ajcn.113.064584. Epub 2013 Sep 4.