| 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
|
|
|
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). |