Improving Compliance to Iron and Folic Acid Supplementation Protocols: Experimental Evidence from Rural India

Last registered on February 09, 2021
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Pre-Trial

Trial Information

General Information

Title
Improving Compliance to Iron and Folic Acid Supplementation Protocols: Experimental Evidence from Rural India
RCT ID
AEARCTR-0007143
Initial registration date
February 09, 2021

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
February 09, 2021, 7:37 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
February 09, 2021, 7:44 AM EST

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
India
Region
Uttar Pradesh

Primary Investigator

Name
Tirtha Patel
Affiliation
Centre for Social and Behaviour Change (CSBC), Ashoka University
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Diksha Radhakrishnan
PI Affiliation
Centre for Social and Behaviour Change (CSBC), Ashoka University
Contact Investigator
PI Name
Sharon Barnhardt
PI Affiliation
Centre for Social and Behaviour Change (CSBC), Ashoka University
Contact Investigator
PI Name
Pavan Mamidi
PI Affiliation
Centre for Social and Behaviour Change (CSBC), Ashoka University
Contact Investigator

Additional Trial Information

Status
Completed
Start date
2020-10-22
End date
2021-01-22
Keywords
Health
Additional Keywords
IFA Supplementation, Nutrition
JEL code(s)
I12
Secondary IDs
Abstract
In this randomised controlled trial study, we will evaluate the impact of three communication-based interventions, delivered remotely, on improving the consumption of Iron and Folic Acid (IFA) supplements during pregnancy in rural India. Our interventions aim to make the risks of anemia for both mother and child salient, increase the value perception of IFA supplements amongst pregnant women, and support the habit formation of their daily consumption. We test for these interventions using two experiments; in the first, we randomize pregnant women with access to Whatsapp between control and a treatment, where the treatment group is given simplified counselling over the phone followed by some visual reinforcements over Whatsapp; in our second, we randomize pregnant women without access to Whatsapp between control and two treatments, where one treatment group is given simplified counselling over the phone followed by regular prescriptions of IFA tablets sent through SMS, and the second treatment group is sent catchy and tuneful IVRS reminders for regular tablet consumption. We deploy our experiments in rural Uttar Pradesh, with a sample of 1929 pregnant women.
External Link(s)

Registration Citation

Citation
Barnhardt, Sharon et al. 2021. "Improving Compliance to Iron and Folic Acid Supplementation Protocols: Experimental Evidence from Rural India." AEA RCT Registry. February 09. https://doi.org/10.1257/rct.7143-1.1
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
We have three interventions that we test in our two separate experiments:

(1) IVRS Reminders:
(a) Series of 13 behaviorally designed reminders using insights to grab attention and increase recall
(b) They were meant to invoke joy, humor, and excitement about the new baby while reminding individuals to consume IFA tablets daily for ensuring the baby’s health
(c) Delivered daily for the first 7 days and then every 2 days for the next 3 weeks

(2) Phone Counselling + SMS Prescription:
(a) Pregnant women were called on the phone (early morning or at night) and counseled on IFA and anemia
(b) The tone of the counseling was joyful and conveyed respect
(c) Script highlighted the risk of anemia
(d) Delivered 1 day after the pregnant women received phone counseling
(e) A prescription for IFA tablets with standard government-recommended dosage, along with instructions for avoiding side effects was sent to select pregnant women
(f) Personalized with the woman’s name and sent once every week for 4 weeks

(3) Phone Counselling + Whatsapp Visual Reinforcement
(a) Pregnant women were called on the phone (early morning or at night) and counseled on IFA and anemia
(b) The tone of the counseling was joyful and conveyed respect
(c) Script highlighted the risk of anemia
(d) Delivered 1 day after the pregnant women received phone counseling
(e) Smartphone users in this arm received visual information about risks to repeat the key framing
(f) Sent once every week for 4 weeks
Intervention Start Date
2020-12-02
Intervention End Date
2021-01-15

Primary Outcomes

Primary Outcomes (end points)
Our primary outcome variables are practice-related outcomes:
1. Total Consumption - total number of IFA tablets consumed
2. Adherence to Total Consumption - rate of regular consumption at Endline and rate of regular consumption between Baseline and Endline
3. Daily Consumption in the previous week - average number of tablets consumed in a day in the previous week
4. Adherence in the previous week - rate of regular consumption over a week
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Our secondary outcome variables are:
1. Knowledge-related variables: Awareness about Anemia, Knowledge about Anemia's symptoms and risks and Knowledge about IFA tablets' side effects
2. Attitude-related variables: Risk perception of Anemia, Threat perception of IFA tablet non-consumption (to mother and child), Intention to consumption, Self-Efficacy, Value perception of IFA tablets
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Our research design is a straightforward randomised controlled field trial, where pregnant women between 4th to 8th month of the pregnancy are eligible for either the Feature Phone based experiment or the Smart Phone based experiment -- depending on whether they have access to WhatsApp.
1. Experiment 1a (Feature Phone Experiment): Participants were randomised between Control group, IVRS Reminders Treatment and Phone Counselling + SMS Prescription Treatment
2. Experiment 1b (Smart Phone Experiment): Participants were randomised between Control group, and Phone Counselling + Whatsapp Visual Reinforcement Treatment

Our treatments are bookended by a baseline and an endline, where we measure IFA tablet consumption and adherence practices, attitudes and intentions, along with standard demographics.
Experimental Design Details
Randomization Method
Randomization was performed using the computational software R.
Randomization Unit
We conducted stratified randomization at an individual level for both the experiments.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
Clustering is not applicable to either of the two experiments.
Sample size: planned number of observations
Experiment 1a: 1477 pregnant women Experiment 1b: 646 pregnant women
Sample size (or number of clusters) by treatment arms
Experiment 1a:
Control: 492 pregnant women
IVRS Reminders: 492 pregnant women
Phone Counselling + SMS Prescription: 493 pregnant women

Experiment 1b:
Control: 324 pregnant women
Phone Counselling + Whatsapp Visual Reinforcement: 322 pregnant women
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Ashoka University Institutional Review Board
IRB Approval Date
2020-09-27
IRB Approval Number
24_20_Patel
Analysis Plan

Analysis Plan Documents

IFA Supplementation RCT Pre-Analysis Plan

MD5: 902642ccfd31e8781a6c1ef9d608a6e9

SHA1: 627ddfcdd6fed51ebe3c5f7527d385624a61ac1a

Uploaded At: February 09, 2021

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
January 15, 2021, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
January 22, 2021, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
Was attrition correlated with treatment status?
Final Sample Size: Total Number of Observations
Final Sample Size (or Number of Clusters) by Treatment Arms
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials