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Incentivising fruit and vegetable consumption in urbanising India
Last registered on April 29, 2021

Pre-Trial

Trial Information
General Information
Title
Incentivising fruit and vegetable consumption in urbanising India
RCT ID
AEARCTR-0004939
Initial registration date
December 14, 2019
Last updated
April 29, 2021 1:50 PM EDT
Location(s)

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Primary Investigator
Affiliation
LSHTM
Other Primary Investigator(s)
Additional Trial Information
Status
On going
Start date
2019-11-01
End date
2021-06-30
Secondary IDs
Abstract
The majority of the rural Indian population do not consume adequate amounts of fruit and vegetables, which is a key risk factor for morbidity and mortality. Food prices are a key barrier to healthy diets. The aim of this study is to implement and evaluate a sustainable financial incentive scheme to increase fruit and vegetables purchase in rural India. The study is nested within the Andhra Pradesh Children and Parents Study (APCAPS) in rural Telangana, India, and the intervention will be implemented in three randomly selected villages for six months, with another three villages as controls. We will use both quantitative and qualitative methods with community members (N=1,500 households), fruit and vegetable vendors, and local stakeholders (e.g. village leaders) to assess the short-term effect on fruit and vegetables purchasing, assess perceptions of the intervention and potential adverse effects, and establish the need for a full-scale trial which would evaluate the impact on clinical outcomes.
External Link(s)
Registration Citation
Citation
Kinra, Sanjay. 2021. "Incentivising fruit and vegetable consumption in urbanising India." AEA RCT Registry. April 29. https://doi.org/10.1257/rct.4939-2.1.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
The intervention will be implemented at the village level for 3-months. The financial incentive scheme consists of a coupon, on which participants will receive a stamp for every Rs. 10 (Indian rupees) spent on fruit and vegetables from a participating local vendor. If participants spend Rs. 250 within one week, they will receive a Rs. 50 reimbursement from the APCAPS field team.
Intervention Start Date
2020-01-01
Intervention End Date
2021-03-17
Primary Outcomes
Primary Outcomes (end points)
Amount (kg) of fruit and vegetables purchased per week per household
Primary Outcomes (explanation)
We shall conduct a quantitative survey of randomly selected households of the intervention and control villages at baseline and after 3-months (i.e. at the end of the implementation period). The same household member will be surveyed at each time point, and we shall ask for information on the quantity of different fruit and vegetables purchased for all members of household over a one week period (we shall survey them on alternate days of the week, asking about the previous two days for maximum accuracy). For items that are frequently reported in measures other than weight (e.g. bunches or pieces) we have previously collected data on the weight of locally traded fruit and vegetable servings, which we will use to convert the amount of fruit and vegetables purchased to weight in kg. The amount (kg) of fruit and vegetables will be summed per household per week to generate the amount of fruit and vegetable purchased.
Secondary Outcomes
Secondary Outcomes (end points)
(1) Amount spent (Indian rupees) on fruit and vegetables per week per household
(2) Quantity of fruit and vegetables obtained (in kg) from all sources by households in a week (i.e. sum of purchase, own production, gifts, wild harvest and others).
(3) For the quantity (in kg) and value (in rupees) of fruit and vegetables sold by vendors in a week (from vendor survey)/
(4) Process evaluation of intervention (following the Medical Research Council Framework)
a. Intervention delivery: Fidelity e.g. % of vendors not stamping on a given day/not wearing a badge; dose e.g. % of total stamped circles out of 600 for each participant; reach e.g. % of customers who have used the coupon for >12 weeks with at least 12 stamps
b. Causal mechanisms e.g. % of customers who stated that they could not afford to purchase Rs. 500 of fruit and vegetables, % of customers who stated that they were doubtful of being reimbursed Rs. 100 by the programme
c. Contextual factors: e.g. variety and quality of fruit and vegetables available
Secondary Outcomes (explanation)
The amount spent (in Indian rupees) on fruit and vegetables and quantity of fruit and vegetables obtained from other sources in the previous week will also be collected during the quantitative survey of the randomly selected households (alongside the primary outcome). Vendors will be surveyed once per month during the follow-up period, for quantity and value of fruit and vegetables sold. A process evaluation will combine routinely collected data (the redeemed coupons), a monthly quantitative vendor survey (to estimate the volume and cost of purchase and sales), a weekly vendor audit survey (conducted through observations by the field team), an intervention evaluation survey with participating households and vendors (conducted in the final month of the intervention), and qualitative interviews with local stakeholders (e.g. government personnel, Anganwadi workers). The process evaluation will evaluate how the intervention was implemented, the potential causal mechanisms (for instance perception and understanding of the intervention), unexpected outcomes, and the contextual factors that may have affected intervention implementation and consequences.
Experimental Design
Experimental Design
The intervention will be implemented in 3 randomly selected villages within the APCAPS study site, with another 3 randomly selected villages as controls. All households and all fruit and vegetable vendors of the intervention villages will be eligible and invited to participate in the scheme, and coupon booklets and stamps will be distributed at baseline to all participating community members and vendors respectively. The control villages will not receive any intervention. 1,500 households will be randomly selected across the 6 villages (750 intervention and 750 control) and repeated surveys will be used to estimate their fruit and vegetable purchasing.
Experimental Design Details
Not available
Randomization Method
Done in office by computer using a previous household survey of APCAPS villages.
Randomization Unit
Villages.
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
6 villages (3 intervention, 3 control) (randomly selected from 8 of 29 total APCAPS villages with the following characteristics: within the interquartile range of population size (excluding villages with populations <500 or >5,000), number of vendors, and proportion of the population purchasing fruit and vegetables within the village.)
Sample size: planned number of observations
1,182 households surveyed in total (recruiting 1,500 to allow loss to follow-up)
Sample size (or number of clusters) by treatment arms
591 households in intervention villages, 591 households in control villages
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We had originally calculated that a sample of 1,182 participants is required to detect a 10% difference between intervention and control arms in our primary outcome of weekly household fruit and vegetables purchase (in kg), with 80% power and at 5% significance level (assuming mean household weekly fruit and vegetable purchase of 10.4kg with standard deviation 4.5kg, estimated from previous data). This sample size estimate accounts for the fact that each participant will be followed up 3 times (within-person intra-cluster correlation coefficient of 0.4, estimated from previous data) and participants are clustered in villages (within-village intra-cluster correlation coefficient of 0.02, estimated from previous data). To allow for possible loss-to-follow-up during the study, we planned to recruit 1500 participants in total (250 from each village). After the study was delayed and shortened due to the COVID-19 lockdown in India, we revised the above sample size calculation as follows: with 1500 (1200 after allowing for loss to follow-up), we would have 80% power (at 5% significance level) to detect a ~15% difference in primary outcome of household fruit and vegetable purchase (assumptions as above, except without repeat measures per individual).
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Indian School of Business Institutional Review Board
IRB Approval Date
2019-07-12
IRB Approval Number
ISB-IRB- 2019-05
IRB Name
London School of Hygiene Ethics Committee
IRB Approval Date
2019-12-10
IRB Approval Number
15688
Analysis Plan
Analysis Plan Documents
Statistical Analysis Plan (V-29042021)

MD5: 13863641b677da8ceea0b9eef3761d50

SHA1: ce04ee01c793bf8f5a39818130bb006c76aacb84

Uploaded At: April 29, 2021