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General

Study Overview

Title:

Impact Evaluation of Integrating Double Fortified Salt (DFS) to Reduce Anemia in recipients of the PDS Program in UP, India

Study is 3ie funded:

No

Study ID:

RIDIE-STUDY-ID-58f6eeb45c050

Initial Registration Date:

04/18/2017

Last Update Date:

03/19/2020

Study Status:

Ongoing

Abstract:

We propose an evaluation of a double fortified salt (DFS) program in Uttar Pradesh (UP) on reduction of anemia in women of reproductive age (WRA) who are recipients of the Public Distribution System (PDS). The UP government is funding the distribution and supporting the subsidized sale of DFS through the PDS in ten districts for a period of three years; the results of this evaluation will be used to make decisions related to continuity and further scale-up. We propose a baseline cross-sectional survey of 1250 households, selected from five intervention districts and five control districts using a 2-stage cluster randomized sampling strategy. The five intervention districts chosen for this evaluation were randomly selected from the ten; control districts were randomly selected based on adjacency to the five intervention districts. The primary objective of the baseline survey is to examine the prevalence of anemia in WRA and determine PDS accessibility for the intervention households. A midline cross-sectional coverage survey of 1200 households which have access to the PDS is proposed ~6 months after DFS commencement in the five intervention districts (which were part of the baseline). The primary objective of the midline survey is to assess the coverage and utilization of the DFS through the PDS. Based on the midline utilization rates, an endline cross-sectional survey is proposed in two of the five intervention districts and their adjacent control districts. The intervention districts in the endline survey were determined based on coverage survey results, where the selected intervention district had to meet the evaluability threshold of at least 50% DFS utilization rates. 6200 households with access to the PDS will be surveyed for the endline assessment in the intervention and control districts; hemoglobin, iron, iodine and inflammation status in WRA will also be estimated during the endline survey. 

Change History for Abstract

Changed On

Previous Value

07/03/2019

We propose an evaluation of a double fortified salt (DFS) program in Uttar Pradesh (UP) on reduction of anemia in women of reproductive age (WRA) who are recipients of the Public Distribution System (PDS). The UP government is funding the distribution and supporting the subsidized sale of DFS through the PDS in ten districts for a period of three years; the results of this evaluation will be used to make decisions related to continuity and further scale-up. We propose a longitudinal study of 2880 households which have access to the PDS, selected from five intervention districts five control districts using a 2-stage cluster randomized sampling strategy. The five intervention districts chosen for this evaluation were randomly selected from the ten which are intended to receive the DFS program starting in January 2017; control districts were randomly selected based on adjacency to the five intervention districts. The primary objective is to examine prevalence of anemia in WRA and coverage and utilization of the DFS through the PDS. Timing of the endline survey will be determined based on coverage surveys throughout the planned three-year program period.

Registration Citation:

Neufeld, L. and Swaminathan, S., 2017. Impact Evaluation of Integrating Double Fortified Salt (DFS) to Reduce Anemia in recipients of the PDS Program in UP, India. Registry for International Development for Impact Evaluations (RIDIE). Available at: 10.23846/ridie104

Categories:

Health, Nutrition, and Population

Additional Keywords:

nutrition, double fortified salt, uttar pradesh, india, micronutrient malnutrition

Secondary ID Number(s):

2016-109-CP-exp Sanjay Gandhi Postgraduate Institute of Medical Sciences

Principal Investigator(s)

Name of First PI:

Dr. Lynnette Neufeld

Affiliation:

Global Alliance for Improved Nutrition

Name of Second PI:

Dr. Sumathi Swaminathan

Affiliation:

St John's Research Institute

Intervention

Intervention Overview

Intervention:

The program plans to distribute Double Fortified Salt (DFS) at a subsidized rate through the Public Distribution System (PDS) in 10 districts in Uttar Pradesh (UP). Expected beneficiaries are recipients of the Public Distribution System in those districts. There are two types of ration cards and entitlements/prices differ based on which is owned by the head of the household: Above-1) Priority Households (PHH) 2) Antyodaya Anna Yojana (AAY) which targets the poorest families. The main project objective is to develop a cost-effective and sustainable means to reduce the incidence of anemia by 1) refining, transferring and scaling up technology for DFS, 2) facilitating its large scale application through the PDS in UP, 3) developing a base of evidence to inform public policy with aim of mass implementation through eventual government decree in India and elsewhere.

Change History for Intervention

Changed On

Previous Value

07/03/2019

The program plans to distribute Double Fortified Salt (DFS) at a subsidized rate through the Public Distribution System (PDS) in 10 districts in Uttar Pradesh (UP). Expected beneficiaries are recipients of the Public Distribution System in those districts. There are three types of ration cards and entitlements/prices differ based on which is owned by the head of the household: Above-the-poverty-line (APL), 2) Below-the-poverty-line (BPL) and 3) Antyodaya Anna Yojana (AAY) which targets the poorest families. The main project objective is to develop a cost-effective and sustainable means to reducing the incidence of anemia by 1) refining, transferring and scaling up technology for DFS, 2) facilitating its large scale application through the PDS in UP, 3) developing a base of evidence to inform public policy with aim of mass implementation through eventual government decree in India and elsewhere.

Theory of Change:

Double fortified salt (DFS) will be distributed through the Public Distribution System (PDS) where households come to purchase subsidized food rations on a monthly basis. The PDS owner will communicate about DFS benefits for the household beneficiary as they purchase the rations, including DFS. Once the DFS is purchased, the households will begin to use it in their day-to-day cooking. They will be aware that this salt contains both iron and iodine, and this message will be reinforced by the local community health worker and DFS program staff who visit the districts from time to time. 

 

Multiple Treatment Arms Evaluated?

No

Intervention Timing

Intervention or Program Started at time of Registration?

Yes

Change History for Intervention Timeline

Changed On	Previous Value
07/03/2019	No

Start Date:

01/01/2018

Change History for Start Date

Changed On	Previous Value
07/03/2019	05/01/2017
06/27/2017	01/01/2017

End Date:

Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:

Regression with controls

Change History for Primary (or First) Evaluation Method

Changed On	Previous Value
01/15/2020	Instrumental variables
07/03/2019	Matching

Other (not Listed) Method:

Additional Evaluation Method (If Any):

Instrumental variables

Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

Baseline survey on 1250 households indicates the prevalence of anemia and iron deficiency in the intervention and control districts. The midline survey indicated the levels of coverage and utilization rates. Based on this, two high performing intervention districts and their adjacent districts will be included in the endline assessment. High performing districts are defined as those that meet an a priori defined “evaluability” threshold of 50% DFS utilization, i.e. 50% of the households included in the midline coverage survey indicated that they use DFS in their household meals. Key nutritional indicators and their primary determinants were collected at baseline for one non-pregnant woman 18-49 years of age and one child 6 months -5 years of age per household, with one household member in each group selected randomly if more than 1 WRA and/or child 6mo to 5 y of age lives in the household.  For the endline, the scope of the survey is focused on non-pregnant women between age 18-49 years and their micronutrient status (restricted to Hemoglobin concentration (Hb), serum ferritin, inflammation). We will collect information on socio-demographic and economic status, including housing conditions, employment, education, among others and updates to access to water, sanitation, hygiene services apart from purchasing patterns and utilization of all types of salt (including DFS in intervention areas) and morbidity status. All information proposed is aligned with and will be collected for comparability with baseline assessments. We propose to use an instrumental variable regression approach, adjusted for clustering, to examine the impact of DFS in the prevalence of anemia in WRA who live in intervention districts compared to the control districts. 

Change History for Details of Evaluation Approach

Changed On	Previous Value
07/03/2019	We propose a longitudinal study to examine prevalence of anemia in 2880 non-pregnant women of reproductive age (WRA) living in intervention and control communities. Out of the ten districts chosen to be included in the DFS program by the UP government, five were randomly selected to be included in this evaluation; five adjacent districts were randomly selected to serve as controls. Control districts were chosen based on adjacency to the intervention districts to ensure that individuals match on socio-economic and –demographic factors which may also influence prevalence of anemia. We expect little spillover to occur given the PDS ration shops strictly serve communities within their jurisdiction and these communities are separated by the district borders. We propose to use linear mixed models adjusted for clustering to examine the difference-in-difference in prevalence of anemia in WRA who are recipients of the PDS.
07/03/2019	We propose a longitudinal study to examine prevalence of anemia in 2880 non-pregnant women of reproductive age (WRA) living in intervention and control communities. Out of the ten districts chosen to be included in the DFS program by the UP government, five were randomly selected to be included in this evaluation; five adjacent districts were randomly selected to serve as controls. Control districts were chosen based on adjacency to the intervention districts to ensure that individuals match on socio-economic and –demographic factors which may also influence prevalence of anemia. We expect little spillover to occur given the PDS ration shops strictly serve communities within their jurisdiction and these communities are separated by the district borders. We propose to use linear mixed models adjusted for clustering to examine the difference-in-difference in prevalence of anemia in WRA who are recipients of the PDS.

Outcomes (Endpoints):

Change in prevalence of anemia in non-pregnant women of reproductive age. Utilization, consumption, and acceptability of Double Fortified Salt among recipients of the Public Distribution System.

Change History for Outcomes (Endpoints)

Changed On	Previous Value
07/03/2019	Change in prevalence of anemia in non-pregnant women of reproductive age. Utilization, consumption, and acceptability of Double Fortified Salt among recipients of the Public Distribution System.

Unit of Analysis:

Non-pregnant women of reproductive age

Hypotheses:

We hypothesize a at least a 20 percentage point drop in the prevalence of anemia in non-pregnant women of reproductive age who are recipients of the Public Distribution System. A study by Anderson et al (2008) demonstrated a 60% reduction in anemia in school-aged children using 2mg Fe/g of salt. The current study will use a formulation for the DFS that includes a maximum of 1050ppm of iron (as ferrous fumarate), which would result in a mean daily intake of 11.5mg (95% CI 9.8, 13.2) of iron per day. Given this is an effectiveness trial and given the lower concentration of iron in the present study compared to Anderson et al's 2008 trial, we use a conservative estimate and hypothesize a 20 percentage point reduction in anemia (from 75% to 55%). Current prevalence of anemia is based on the CAB 2014.

Change History for Hypotheses

Changed On

Previous Value

07/03/2019

We hypothesize a at least a 20 percentage point drop in the prevalence of anemia in non-pregnant women of reproductive age who are recipients of the Public Distribution System. A study by Anderson et al (2008) demonstrated a 60% reduction in anemia in school-aged children using 2mg Fe/g of salt. The current study will use a formulation for the DFS that includes a maximum of 1050ppm of iron (as ferrous fumarate), which would result in a mean daily intake of 11.5mg (95% CI 9.8, 13.2) of iron per day. Given this is an effectiveness trial and given the lower concentration of iron in the present study compared to Anderson et al's 2008 trial, we use a conservative estimate and hypothesize a 20 percentage point reduction in anemia (from 75% to 55%). Current prevalence of anemia is based on the CAB 2014.

Unit of Intervention or Assignment:

District

Number of Clusters in Sample:

10 for baseline

Change History for Number of Clusters in Sample

Changed On	Previous Value
07/03/2019	10

Number of Individuals in Sample:

1250 individuals for baseline; 1200 for midline; 6200 for endline

Change History for Number of Individuals in Sample

Changed On	Previous Value
07/03/2019	2880 individuals

Size of Treatment, Control, or Comparison Subsamples:

Five intervention and five control districts will be matched at the district level, to ensure they match on socio-economic and –demographic characteristics which may influence anemia (other than DFS).

Data

Outcomes Data

Description:

At baseline, a household survey will examine socio-demographic and –economic factors, access to and perceptions of ration shops, etc. A 24 hour recall questionnaire will be used to assess dietary intake. We plan to take anthropometry and blood measurements. Blood samples will be analyzed for anemia, iron, vitamin A, vitamin D, folic acid, vitamin B12, zinc, iodine, malaria, inflammation, and beta-thalassemia status. As of now, at endline, a household survey and hemoglobin will be measured.

Data Already Collected?

No

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Treatment Assignment Data

Participation or Assignment Information:

Yes

Description:

Data Obtained by the Study Researchers?

Data Previously Used?

Data Access:

Data Obtained by the Study Researchers?

Data Approval Process:

Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:

Prospective, Category 1: Data for measuring impacts have not been collected

Completion

Completion Overview

Intervention Completion Date:

Data Collection Completion Date:

Unit of Analysis:

Clusters in Final Sample:

Total Observations in Final Sample:

Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:

Preliminary Report URL:

Summary of Findings:

Paper:

Paper Summary:

Paper Citation:

Data Availability

Data Availability (Primary Data):

Date of Data Availability:

Data URL or Contact:

Access procedure:

Other Materials

Survey:

Survey Instrument Links or Contact:

Program Files:

Program Files Links or Contact:

External Link:

External Link Description:

Description of Changes:

Study Stopped

Date:

Reason: