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CTRI Number  CTRI/2018/10/016186 [Registered on: 29/10/2018] Trial Registered Prospectively
Last Modified On: 30/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Anemia Prevention 
Scientific Title of Study   Designing and implementing a maternal iron deficiency and anaemia control strategy in India using a social norms approach and a Self Help Group (SHGs) platform. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raghwesh Ranjan 
Designation  Primary Investigator 
Affiliation  IPE Global Limited 
Address  B-84, Defence Colony

New Delhi
DELHI
110024
India 
Phone    
Fax    
Email  raghwesh@ipeglobal.com  
 
Details of Contact Person
Scientific Query
 
Name  Satyanarayan Mohanty 
Designation  Primary Investigator 
Affiliation  DCOR Consulting 
Address  Corporate Office: DCOR Consulting 131 (P), Punjabi Chhak, Satyanagar, Bhubaneswar – 751 007

Khordha
ORISSA
751007
India 
Phone    
Fax    
Email  Satya.dcor@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Satyanarayan Mohanty 
Designation  Primary Investigator 
Affiliation  DCOR Consulting 
Address  Corporate Office: DCOR Consulting 131 (P), Punjabi Chhak, Satyanagar, Bhubaneswar – 751 007

Khordha
ORISSA
751007
India 
Phone    
Fax    
Email  Satya.dcor@gmail.com  
 
Source of Monetary or Material Support  
The Bill and Melinda Gates Foundation 440 5th Ave N, Seattle, WA 98109 United States 
 
Primary Sponsor  
Name  The George Washington University 
Address  950 New Hampshire Ave NW Washington, DC 20052, United States 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
IPE Global Limited  B-84, Defence Colony, New Delhi, Delhi 110024, India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Raghwesh Ranjan  The RANI Project  Collectrate, Angul AT/POST- ANGUL Odisha-759122
Anugul
ORISSA 
06764230144

raghwesh@ipeglobal.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
George Washington University  Approved 
Sigma Research and Consulting  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Anemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Behavioral Intervention  Randomly selected villages that will not be exposed to the behavior intervention. This group will not receive intervention related messages. 
Intervention  Behavioral Intervention  These randomly selected villages will be exposed to the behavioral intervention that promotes the use of iron folic acid supplements and an iron rich diet. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Outcomes will be measured in pregnant and non-pregnant women of reproductive age. 
 
ExclusionCriteria 
Details  Participants must live in the selected villages. Pregnant women will be excluded from the physical activity tests or cognitive functioning tests. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Aneamia status through hemoglobin tests and IFA utilization (purchase and consumption)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
work capacity (modified Queens College Step test)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
socio-cognitive functioning (through Simple Reaction Time task, Corsi Block Test, Simon Test, and word span assessments)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
social norms, gender norms knowledge, self-efficacy, mental health, attitudes, nutrition, WASH, and de-worming (from questionnaires)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
IFA supplement purchase and procurement   Aug-Sept 2019; Feb-March 2020; September-October 2020 
Psychical Activity (through ActivePal)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
Anemia testing (self-report)  Feb-March 2020; September-October 2020 
Exposure to intervention  Feb-March 2020; September-October 2020 
BMI (weight and height measurements)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
self efficacy to intervene on violence against women (for the control arm of mHealth component)  Aug-Sept 2019; Feb-March 2020; September-October 2020 
 
Target Sample Size
Modification(s)  
Total Sample Size="4110"
Sample Size from India="4110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/01/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial
Modification(s)  
Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  
Yilma, H., Sedlander, E., Rimal, R. N., Pant, I., Munjral, A., & Mohanty, S. (2020). The reduction in anemia through normative innovations (RANI) project: study protocol for a cluster randomized controlled trial in Odisha, India. BMC public health, 20(1), 203. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
Anemia is a major health concern in Odisha, India where approximately half of women of reproductive age (WRA) are anemic. One of the primary recommendations made by the World Health Organization (WHO) for WRA in India is daily oral iron and folic acid (IFA) supplementation during pregnancy and postpartum period together with uptake of deworming medicines and anti-malarial medicines where appropriate. However, both initial supplement intake and compliance remain inadequate. Some of the primary barriers include: lack of knowledge about the cause of anemia and its health consequences, lack of information from health care providers around the connection between IFA tablets and reduction in anemia, forgetfulness, myths and misperceptions around the effects of IFA tablets on a woman’s body or her fetus, and both perceived as well as experienced side effects of IFA.

We seek to promote changes in social norms, knowledge, attitudes, and behaviors of WRA and pregnant women in Odisha through a communication-based behavioral intervention that will operate in existing Self Help Groups. This is not an efficacy trial. We seek to only increase demand for IFA tablets among WRA, as per the recommendations set forth by the Government of Odisha; 239 randomly selected villages were randomized into treatment and control arms so that there are 130 villages villages exposed to the behavioral intervention and 109 that are not. 

We hypothesize that exposure to the behavioral intervention will result in increases in IFA demand and utilization, and subsequently reductions in anemia. We will test this hypothesis through measuring change in hemoglobin level, IFA use, knowledge, attitudes, beliefs, and perceptions in approximately 2,061 randomly selected pregnant and non-pregnant WRA that reside in the intervention arm and 2,049 randomly selected WRA that reside in the control arm. A small sub-cohort of non-pregnant women will be randomly selected from this group for further measurements of change in physical activity and cognitive functioning. Women in the treatment group who own a phone will also be randomized into a sub-study delivered through a mobile health platform. These women will either be randomized into an arm where they will receive norms-based anemia messages, violence against women bystander messages (positive control), or nothing at all (negative control).
 
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