Promoting homestead gardens to improve dietary diversity in Rural India: a randomized controlled trial

ISRCTN	ISRCTN79401136
DOI	https://doi.org/10.1186/ISRCTN79401136
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	CARE USA US3J3/ANO5US0002/8
Sponsors	CARE USA, Rose C. Gangarosa
Funders	CARE USA, Rose C. Gangarosa

Submission date: 21/05/2024
Registration date: 28/05/2024
Last edited: 06/01/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Many people in rural India suffer from poor nutrition because they cannot afford or otherwise do not have access to a full range of food groups. While backyard gardens could produce crops to supplement existing diets, irrigation water is often unavailable during growing seasons - a barrier that will be aggravated by climate change. This study aims to test an intervention designed to increase the consumption of a wider range of foods by promoting backyard gardens irrigated with “grey water” - relatively clean wastewater from dishwashing and bathing.

Who can participate?
Households in 82 communities in Ganjam and Gajapati Districts of Odisha, India

What does the study involve?
Half of the communities will be randomly assigned to receive the intervention. The intervention includes community activities designed to build awareness and capacity, as well as the provision of seeds, fencing, irrigation equipment and pest-control strategies. The intervention will be delivered by Gram Vikas, an Indian NGO. The other communities will initially serve as controls and will be offered the intervention at the end of the 12-month trial. Dietary diversity is assessed by recording the number of food groups consumed in the previous day based on a 24-hour dietary recall.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Emory University (USA)

When is the study starting and how long is it expected to run for?
January 2024 to December 2026

Who is funding the study?
1. CARE USA
2. Rose C. Gangarosa

Who is the main contact?
Dr Sheela Sinharoy, Sheela.sinharoy@emory.edu

Contact information

Dr Sheela Sinharoy
Public, Scientific, Principal investigator

1518 Clifton Rd NE
Atlanta
30322
United States of America

ORCID ID	0000-0003-3077-3824
Phone	+1 (0)404 778 2017
Email	sheela.sinharoy@emory.edu

Dr Thomas Clasen
Scientific, Principal investigator

1518 Clifton Rd NE
Atlanta
30322
United States of America

ORCID ID	0000-0003-4062-5788
Phone	+1 (0)404 727 3480
Email	thomas.f.clasen@emory.edu

Study information

Primary study design	Interventional
Study design	Non-blinded cluster-randomized controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Climate Resilient Odisha Produce Study (CROPS): a randomized controlled trial in rural Odisha, India
Study acronym	CROPS
Study objectives	Individuals living in households that receive the intervention will have significantly higher dietary diversity than individuals living in households that do not receive the intervention.
Ethics approval(s)	1. Approved 15/04/2024, Emory University IRB (1599 Clifton Rd NE, Atlanta, 30322, United States of America; +1 (0)404 727 3889; irb@emory.edu), ref: STUDY00007613 2. Approved 20/05/2024, Independent Ethics Committee of XIM University (Plot No.12(A), Nijigada, Kurki, Harirajpur, Puri, Odisha, 752050, India; +91 (0)674 23777000; deansgpa@xim.edu.in), ref: XU2024520212VC
Health condition(s) or problem(s) studied	Dietary diversity
Intervention	Current interventions as of 06/01/2026: Following enrollment and baselining of study participants, the 82 rural villages in Ganjam and Gajapati Districts in Odisha will be randomized using a random number generator either to the intervention arm (41 communities) or the control arm (41 communities). Intervention arm: 1. Community meetings/trainings to: 1.1. Build knowledge, skills, and self-efficacy related to climate-smart agricultural techniques for year-round production of fruits and vegetables through backyard gardens 1.2. Improve knowledge of the importance of dietary diversity for all household members and self-efficacy related to food preparation and distribution 1.3. Increase women’s negotiating and decision-making power in the household 2. Distribution of inputs and hardware including seeds and seedlings, supplies for integrated pest management (e.g., fencing material), and hardware for greywater capture and re-use (e.g., PVC pipes, watering cans) Control arm: No intervention (offered the intervention at the end of the trial) The trial will be conducted from June 2024 to June 2026. The study protocol and ethics approvals authorize additional follow-up for up to 24 months following the completion of the trial to assess longer-term impacts. Current interventions as of 12/09/2024: Following enrollment and baselining of study participants, the 82 rural villages in Ganjam and Gajapati Districts in Odisha will be randomized using a random number generator either to the intervention arm (41 communities) or the control arm (41 communities). Intervention arm: 1. Community meetings/trainings to: 1.1. Build knowledge, skills, and self-efficacy related to climate-smart agricultural techniques for year-round production of fruits and vegetables through backyard gardens 1.2. Improve knowledge of the importance of dietary diversity for all household members and self-efficacy related to food preparation and distribution 1.3. Increase women’s negotiating and decision-making power in the household 2. Distribution of inputs and hardware including seeds and seedlings, supplies for integrated pest management (e.g., fencing material), and hardware for greywater capture and re-use (e.g., PVC pipes, watering cans) Control arm: No intervention (offered the intervention at the end of the 12-month trial) The trial will continue for a period of approximately 18 months from June 2024 to December 2025. The study protocol and ethics approvals authorize additional follow-up for up to 24 months following the completion of the trial to assess longer-term impacts. Previous interventions: Following enrollment and baselining of study participants, the 90 rural villages in Ganjam and Gajapati Districts in Odisha will be randomized using a random number generator either to the intervention arm (45 communities) or a control arm (45 communities). Intervention arm: 1. Community meetings/trainings to: 1.1. Build knowledge, skills, and self-efficacy related to climate-smart agricultural techniques for year-round production of fruits and vegetables through backyard gardens 1.2. Improve knowledge of the importance of dietary diversity for all household members and self-efficacy related to food preparation and distribution 1.3. Increase women’s negotiating and decision-making power in the household 2. Distribution of inputs and hardware including seeds and seedlings, supplies for integrated pest management (e.g., fencing material), and hardware for greywater capture and re-use (e.g., PVC pipes, watering cans) Control arm: No intervention (offered the intervention at the end of the 12-month trial) The trial will continue for a period of approximately 18 months from June 2024 to December 2025. The study protocol and ethics approvals authorize additional follow-up for up to 24 months following the completion of the trial to assess longer-term impacts.
Intervention type	Mixed
Primary outcome measure(s)	Dietary diversity among adult women measured using a 24-hour dietary recall at baseline, 6, 12, 18 and 24 months Previous primary outcome as of 06/01/2026: Dietary diversity among adult women of reproductive age (18-49 years) is measured using a 24-hour dietary recall at baseline, 6 months, 12 months and 18 months
Key secondary outcome measure(s)	Dietary diversity among children under age 5 and other household members measured using a 24-hour dietary recall at baseline, 6, 12, 18 and 24 months Food insecurity measured using the Food Insecurity Experience Scale (FIES) at baseline, 6, 12, 18 and 24 months Subjective wellbeing measured using the World Health Organization-5 (WHO-5) scale at baseline, 6, 12, 18 and 24 months Self-efficacy measured using researcher-developed questions specific to self-efficacy for gardening and self-efficacy related to nutrition at baseline, 6, 12, 18 and 24 months Agricultural production diversity measured using researcher-developed questions related to variety of crops grown in each season at 18 and 24 months Household water insecurity measured using the Household Water Insecurity Experience (HSWE) scale short form at 18 and 24 months Women's income-earning measured using a researcher-developed questionnaire about participation in work for which payment was received at 18 and 24 months Mid-upper arm circumference (MUAC) among adult women and up to one child under age 5 per household measured using a MUAC z-score measuring tape at 18 and 24 months Previous secondary outcome measures as of 12/09/2024: 1. Dietary diversity among children under age 5 and other household members measured using a 24-hour dietary recall at baseline, 6 months, 12 months and 18 months 2. Food insecurity measured using the Food Insecurity Experience Scale (FIES) at baseline, 6 months, 12 months, and 18 months 3. Subjective wellbeing measured using the World Health Organization-5 (WHO-5) scale at baseline, 6 months, 12 months and 18 months 4. Self-efficacy measured using researcher-developed questions specific to self-efficacy for gardening and self-efficacy related to nutrition at baseline, 6 months, 12 months and 18 months 5. Women’s empowerment measured using questions adapted from the project-level Women’s Empowerment in Agriculture Index at baseline, 6 months, 12 months and 18 months Previous secondary outcome measures: 1. Dietary diversity among children under age 5 measured using a 24-hour dietary recall at baseline, 6 months, 12 months and 18 months 2. Food insecurity measured using the Food Insecurity Experience Scale (FIES) at baseline, 6 months, 12 months, and 18 months 3. Subjective wellbeing measured using the World Health Organization-5 (WHO-5) scale at baseline, 6 months, 12 months and 18 months 4. Self-efficacy measured using researcher-developed questions specific to self-efficacy for gardening and self-efficacy related to nutrition at baseline, 6 months, 12 months and 18 months 5. Women’s empowerment measured using questions adapted from the project-level Women’s Empowerment in Agriculture Index at baseline, 6 months, 12 months and 18 months
Completion date	31/12/2026

Eligibility

Participant type(s)	Population
Age group	All
Lower age limit	0 Years
Upper age limit	110 Years
Sex	All
Target sample size at registration	2050
Total final enrolment	1620
Key inclusion criteria	Current key inclusion criteria as of 06/01/2026: Intervention: Adults 18 years and older, and if applicable, their offspring aged less than 5 years, who live in the study area in Odisha, India Evaluation: Households in 82 communities in Ganjam and Gajapati Districts of Odisha, India Previous participant inclusion criteria as of 12/09/2024: Intervention: Adults 18 years and older who live in the study area in Odisha, India Evaluation: Households in 82 communities in Ganjam and Gajapati Districts of Odisha, India Previous participant inclusion criteria: Intervention: Adults 18 years and older who live in the study area in Odisha, India Evaluation: Households with a child aged under 5 years (up to 25 households, one adult woman and one adult man per household) in each of the intervention and control villages
Key exclusion criteria	1. Adults unable to consent 2. Individuals who do not meet age requirements 3. Prisoners 4. Cognitively impaired or individuals with Impaired Decision-Making Capacity
Date of first enrolment	31/05/2024
Date of final enrolment	31/12/2024

Locations

Countries of recruitment

India

Study participating centres

Gram Vikas, a Non-Governmental Organization registered in India under the Societies Registration Act 1860

Plot No. 72/B
Forest Park, Bhubaneswar
Odisha
751009
India

Ganjam and Gajapati Districts

Odisha
N/A
India

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sheela Sinharoy, sheela.sinharoy@emory.edu.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

06/01/2026: The following changes were made:
1. Completion date was changed from 31/12/2025 to 31/12/2026.
2. Interventions, primary and secondary outcomes, key inclusion criteria, and healthy volunteers allowed were updated.
3. The lower age limit was changed from 18 to 0, and the upper age limit was added.
4. Final enrolment number added.
5. Rose C. Gangarosa added as secondary sponsor and funder.
6. Individual participant data (IPD) sharing plan added.
20/11/2024: The Recruitment end date was changed from 30/11/2024 to 31/12/2024.
12/09/2024: The following changes were made:
1. The interventions were changed.
2. The secondary outcome measures were changed.
3. The participant inclusion criteria were changed.
4. The target number of participants was changed from "2250: Up to 25 households in each of up to 90 communities (45 intervention/45 control)".
5. The recruitment end date was changed from 30/09/2024 to 30/11/2024.
6. The plain English summary was updated to reflect the above changes.
31/05/2024: The recruitment start date was changed from 01/06/2024 to 31/05/2024.
28/05/2024: Study's existence confirmed by Emory University IRB.