Behavioural Nudges and Maternal Diet: Results from a Cluster-Randomised Pilot Trial among Pregnant Women in India

Last registered on June 30, 2025

Pre-Trial

Trial Information

General Information

Title
Behavioural Nudges and Maternal Diet: Results from a Cluster-Randomised Pilot Trial among Pregnant Women in India
RCT ID
AEARCTR-0016289
Initial registration date
June 30, 2025

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
June 30, 2025, 6:17 AM EDT

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

Locations

Primary Investigator

Affiliation
IIT Roorkee

Other Primary Investigator(s)

PI Affiliation
CHRIST (Deemed to be University), Bangalore
PI Affiliation
CHRIST (Deemed to be University), Bangalore

Additional Trial Information

Status
Completed
Start date
2022-03-05
End date
2022-04-30
Secondary IDs
Prior work
This trial is based on or builds upon one or more prior RCTs.
Abstract
Micronutrient shortfalls pose a significant threat to maternal health across India. We conducted a cluster-randomised controlled trial involving 22 primary-health-centre (PHC) catchments in Karnataka, allocating them to one of three behavioural interventions (printed pamphlets; in-house visits by Accredited Social Health Activists (ASHAs); or phone calls by the research team) or to a routine care control group. A panel of 440 pregnant women was surveyed at baseline and four weeks later, with primary outcomes being small meal frequency and two 24-hour dietary diversity indicators (a continuous score and the binary MDD-W). Multi-arm difference-in-differences models, incorporating PHC fixed effects and CR2 cluster-robust standard errors, revealed modest general improvements in outcomes over time across all arms. However, no intervention produced a statistically significant improvement in either meal frequency or dietary diversity beyond the changes observed in the control group. While point estimates for meal frequency trended positive for all intervention arms, these were not statistically significant. For continuous dietary diversity, point estimates for two arms suggested a slight, statistically insignificant relative decline. These conclusions regarding statistical significance remained robust across 100 control group subsampling iterations. Overall, these brief, primarily information-based nudges, even when reinforced by regular ASHA worker visits, failed to substantially alter eating patterns within the four-week study period, indicating that longer duration or multi component strategies may be necessary to achieve substantive dietary change during pregnancy.
External Link(s)

Registration Citation

Citation
Pradeep, Divya, Subramanian S and Vijay Victor. 2025. "Behavioural Nudges and Maternal Diet: Results from a Cluster-Randomised Pilot Trial among Pregnant Women in India." AEA RCT Registry. June 30. https://doi.org/10.1257/rct.16289-1.0
Sponsors & Partners

Sponsors

Experimental Details

Interventions

Intervention(s)
Intervention (Hidden)
The study design and the interventions were approved by the Institutional Review Board of CHRIST (Deemed to be University), Bangalore (Reference ID - CU: RCEC/59/08/21). Informational nudges were designed to create awareness about a healthy diet focusing on meal regularity, meal frequency and diet diversity. The Treatment group was further split into Treatment arms 1, 2 and 3. The nudges designed for intervention are Informational Pamphlets (Based on the concept of MyPlate and modified as per local food habits) provided to all the treatment groups. The pamphlets distributed in the local language has been attached as supplementary file. Treatment arm 1 received the informational pamphlets only. Treatment arm 2 received in-house visits from ASHA workers every 5th day from the day of recruitment while 3 received phone calls from the research team to remind them about the importance of a healthy diet during pregnancy. This was done primarily to examine whether the source of information made any difference in the way women changed their food intake and the composition of food. Both ASHA workers and research team members were given identical scripts to be focused upon during their interaction with the pregnant women. Figure 1 shows the intervention design.
A gap of 28 days between baseline and end-line was maintained to measure the effect of the nudge. The difference in food intake and dietary diversity between baseline and endline were attributed to the behavioural interventions, after controlling for all other relevant factors. The information was collected based on a 24-hour recall of food and beverages consumed prior to the time of the survey. The data was collected twice within a week at both baseline and end-line, using a detailed questionnaire. The intention of conducting the recall twice was to capture variations, if any, in the dietary pattern of pregnant women. A single recall in a week is likely to miss these variations. The questionnaire covered demographic details, and information about intra-household family dynamics in food distribution, meal frequency and diet diversity.
The 24-hour recall approach in this study involved guiding participants to meticulously recount all foods and beverages consumed in the preceding 24 hours. This method ensured the collection of detailed data on portion sizes, preparation methods, and other relevant dietary information. To enhance the accuracy of portion size estimation, standard cups and utensils were displayed to all respondents, helping them gauge their intake relative to these standard measures.
Studies have shown that the 24-hour recall method can maximise response rates and reduce the burden on both respondents and researchers, while still providing high-quality data. The method is extensively used in national dietary surveys to provide detailed dietary intake data. This data is crucial for informing public health policies and nutritional guidelines.
Intervention Start Date
2022-03-22
Intervention End Date
2022-04-18

Primary Outcomes

Primary Outcomes (end points)
Small Meals Frequency
Meal Diversity
Primary Outcomes (explanation)
Small Meals Frequency
Meal frequency during pregnancy is a critical aspect of maternal nutrition that may influence the risk of preterm delivery. Analysis of data from the pregnancy, infection, and nutrition study involving 2,065 women revealed that those who consumed fewer meals and snacks per day had a higher likelihood of delivering preterm, particularly following premature rupture of membranes (Siega-Riz et al., 2001). Other studies recommend that pregnant women consume smaller, more frequent meals rather than larger ones to prevent various food related complications (Abriha et al., 2014; Gete et al., 2020). The interventions in this study specifically targeted improving the number of small meals by emphasizing its importance and the possible low cost or readily available meals the respondents can consider. The number of smaller meals consumed by the pregnant women before breakfast, between breakfast and lunch, between lunch and dinner and after dinner are assessed using an ordinal logistic regression.
The dependent variable is the total count of four smaller meals consumed at various intervals at the endline. Each of these meals is recorded as a yes/no outcome and then summed up to form an ordinal measure of meal frequency. The independent variable is the combined effect of all three interventions, and baseline values are included as controls.





Meal Diversity

To assess changes in dietary diversity, two complementary metrics were employed: the continuous average dietary diversity score and the binary indicator for achieving Minimum Dietary Diversity for Women (MDD-W).
The Minimum Dietary Diversity for Women (MDD-W) is the primary focus, following guidelines from the Food and Agriculture Organization (FAO). MDD-W is a globally recognized indicator designed to evaluate diet quality and serve as a proxy for micronutrient adequacy among women of reproductive age (15-49 years) (Martin-Prével et al., 2015). It is a dichotomous measure indicating whether women have consumed at least five out of ten pre-defined food groups over the previous 24-hour period. These ten food groups are: 1) Grains, white roots and tubers, and plantains; 2) Pulses (beans, peas, and lentils); 3) Nuts and seeds; 4) Dairy; 5) Meat, poultry, and fish; 6) Eggs; 7) Dark green leafy vegetables; 8) Other vitamin A-rich fruits and vegetables; 9) Other vegetables; and 10) Other fruits. Achieving this five-group threshold is considered indicative of a higher likelihood of meeting micronutrient needs. The proportion of women achieving MDD-W was analysed as a key binary outcome.
In addition to the binary MDD-W indicator, a continuous dietary diversity score was also analysed. This score represents the sum of unique food groups (out of the ten listed above) consumed by each woman over the recall period, ranging from 0 to 10. The use of this continuous score provides a more granular measure of dietary diversity, allowing for the detection of changes in the number of food groups consumed, even if these changes do not result in crossing the MDD-W threshold of five food groups. Analyzing the continuous score alongside the binary MDD-W indicator offers a more comprehensive understanding of the interventions' impact on overall dietary patterns and quality.

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
This study employs a cluster-randomised field experiment design, wherein 22 Primary Health Centres (PHCs) were randomly allocated to one of four arms: a control (Arm 4) or one of three information-nudging treatments (Arms 1–3). Each woman is observed twice—at baseline (t = 0) and end-line (t = 1), allowing treatment effects to be identified via a two-period, multi-arm difference-in-differences (DiD) strategy. Under the parallel trends assumption (Angrist & Pischke 2009; Goodman-Bacon 2021), the DiD estimator is unbiased. The validity of this assumption is supported by randomisation at the PHC level and testing for the absence of significant pre-treatment imbalances will support the plausibility of this assumption.
Experimental Design Details
Randomization Method
Randomisation done using RAND command in excel
Randomization Unit
Public Health Centres (PHCs)
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
22 PHCs
Sample size: planned number of observations
415 pregnant women
Sample size (or number of clusters) by treatment arms
Twenty-two Primary Health Centres (PHCs) were drawn at random from the 69 facilities in Chikkaballapur District that lie within 60 km of the District Health Centre. These 22 clusters were then randomised into four arms: Treatment 1 (pamphlet, n = 4 PHCs), Treatment 2 (ASHA home-visit, n = 4), Treatment 3 (reminder phone call, n = 4) and Control (passive, n = 10). Recruitment was carried out by the resident Accredited Social Health Activists (ASHAs), who maintain the antenatal registers for their catchment areas. Baseline enrolment yielded 440 pregnant women aged three to eight months’ gestation—199 in the control arm and 241 across the three intervention arms (81, 80 and 80, respectively).
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials

Documents

Document Name
IRB
Document Type
irb_protocol
Document Description
File
IRB

MD5: b103b52fdda8370cb27814f929bd2d90

SHA1: c5e26ef9057d74b247ed017cca67a9e8f62dda39

Uploaded At: June 27, 2025

IRB

Institutional Review Boards (IRBs)

IRB Name
CENTRE FOR RESEARCH, CHRIST (Deemed to be University), Bangalore, India
IRB Approval Date
2021-09-13
IRB Approval Number
CU: RCEC/59/08/21

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials