History of Changes for Study: NCT05992376

Vegetables for All Evaluation Kenya

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Study Record Versions

Version	Submitted Date	Changes
1	August 8, 2023	None (earliest Version on record)
2	November 16, 2023	Study Status
3	April 18, 2024	Recruitment Status, Study Status, Contacts/Locations and Oversight

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	424604
Brief Title:	Vegetables for All Evaluation Kenya
Official Title:	Impact Evaluation of the Global Alliance for Improved Nutrition (GAIN) Vegetables for All Program in Kenya
Secondary IDs:

Study Status


Record Verification:	August 2023
Overall Status:	Not yet recruiting
Study Start:	September 11, 2023
Primary Completion:	October 31, 2023 [Anticipated]
Study Completion:	October 31, 2025 [Anticipated]

First Submitted:	August 8, 2023
First Submitted that Met QC Criteria:	August 8, 2023
First Posted:	August 15, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 8, 2023
Last Update Posted:	August 15, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	RTI International
Responsible Party:	Principal Investigator Investigator: Valerie Flax Official Title: Senior Research Public Health Analyst Affiliation: RTI International
Collaborators:	Kula Vyema Centre of Food Economics Jomo Kenyatta University of Agriculture and Technology (JKUAT)

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

Global Alliance for Improved Nutrition (GAIN)'s "Vegetables for All" program in Kenya seeks to improve consumption of healthy foods by improving supply, increasing demand, and improving the enabling environment for different vegetables by operating at multiple levels - individuals, households, markets, producers, and policies. RTI and local partners propose to conduct impact and process evaluations of GAIN's program tailored to the theory of change. The evaluation will include a mix of quantitative and qualitative methods and will be guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) evaluation framework.

Detailed Description:

Background: In urban and peri-urban areas in Kenya, Consumption of vegetables is low in bottom of pyramid (BoP) households, which earn < 3.20 US dollars per person per day. To increase vegetable consumption in this population, GAIN will implement the Vegetables for All program, which aims to improve access to safe and fresh vegetables in Fit Food Zones (FFZs) and to generate demand for vegetables through a radio/television campaign and FFZ branding. The main retailers in the FFZ are mama mbogas (vegetable vendors), who will be linked to suppliers that are Good Agricultural Practices (GAP) compliant.

Objective: The overall objectives of the evaluation are: 1) to assess the effectiveness of GAIN's Vegetables for All program for increasing the quantity of vegetables consumed and improving the diet quality of BoP consumers and 2) to conduct a process evaluation of GAIN's program that provides data to support findings of the impact evaluation.

Methods: This study will use a mixed-methods quasi-experimental design in which 124 FFZs are assigned to intervention or control in Nairobi, Kiambu, Machakos, Mombasa, and Nakuru counties. The impacts will be assessed through cross-sectional population-based surveys of households with women 18-49 years who have a child 3-11 years in 62 intervention and 62 control FFZs at baseline and endline (N=1,364 at each time point). Mama mboga surveys will be conducted in all 124 sampled FFZs at baseline, midline, and endline (N=372 at each time point). Qualitative data will be collected at midline and endline. In-depth interviews (IDIs) will be conducted with vegetable value chain actors and other stakeholders (N=18 at each time point). Focus group discussions (FGDs) will be conducted with mama mbogas (20 FGDs at each time point) and household members (20 FGDs at each time point). The analysis will be performed using difference-in-difference estimation (surveys) and thematic content analysis methods (qualitative).

Conditions


Conditions:	Vegetable Consumption
Keywords:	diet vegetables market intervention social and behavior change communication intervention children Kenya

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	Data will be collected through household surveys, mama mboga surveys, in-depth interviews (IDIs), and focus group discussions (FGDs). The protocol team has selected a subset of intervention FFZs for the evaluation and identified an equal number of geographic areas of similar size and level of urbanicity to serve as the controls.
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	4680 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Active Comparator: Intervention

Behavioral: Food system and demand generation

The Vegetables for All program will create FitFood Zones (FFZs) in low-income estates in urban and peri-urban areas with a minimum of 1,000 households and 10 mama mbogas. FFZs are the last mile/point of purchase for delivering a variety of fresh, safe, and accessible vegetables to BoP households. The program will support mama mbogas to source vegetables from Good Agricultural Practices (GAP)-compliant suppliers, support the uptake of digital solutions for mama mbogas to access vegetables, create business-to-business mentorship opportunities, and support county governments to improve market infrastructure. To encourage BoP parents of children 3-11 years to buy and consume more vegetables, the program will include a demand generation component. This will be implemented through a communication campaign, including above-the-line (ATL) activities (mass media such as radio and television), below-the-line (BTL) activities (market activations and others), and FFZ branding.

No Intervention: Control/No Intervention

Outcome Measures


Primary Outcome Measures:
1.	Grams of Vegetables Consumed [ Time Frame: Baseline (September 2023), endline (September 2025) (2 years) ] Change in the mean grams of vegetables consumed during the last 24 hours by children 3-11 years old in BoP households in Fit Food Zones

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:	Yes
Accepts Healthy Volunteers:	Yes
Criteria:	Household Surveys Inclusion Criteria: Reside in the FFZs assigned; Be a woman between 18-49 years old; Have a child 3-12 years old The household earns <$3.20 per person per day; Be able to speak one of the main local languages and/or Kiswahili; Provide informed consent to participate in the study. Mama Mboga Surveys Inclusion Criteria: Be a mama mboga retailer of vegetables in a FFZ in the districts selected for the evaluation; Be in business for at least 6 months Be over 18 years old; Be able to speak one of the main local languages and/or Kiswahili; Provide informed consent to participate in the study. In-depth interviews with value chain actors Inclusion criteria: Be a vegetable supplier to mama mbogas as part of the FFZ, are involved in demand generation activities, or involved in food safety compliance; Be over 18 years old; Be able to speak one of the main local languages and/or Kiswahili; Provide informed consent to participate in the study. Focus group discussion (FGD) participants will be selected from lists of participants in the FFZ and household surveys and will be consented again for the FGDs if they meet the following criteria: FGDs with households Inclusion criteria: Be a woman living in a BoP household in a FFZ selected for the evaluation; Have ever visited a mama mboga's place of business Participated in the baseline survey Be over 18 years old; Be able to speak one of the main local languages and/or Kiswahili; Provide informed consent to participate in the study. FGDs with mama mbogas Inclusion criteria: Be a mama mboga linked to the Vegetables for All project in one of the intervention FFZs Have been a mama mboga for at least 6 months Be over 18 years old; Be able to speak one of the main local languages and/or Kiswahili; Provide informed consent to participate in the study.

Contacts/Locations


Central Contact Person:	Valerie Flax, PhD, MPH Telephone: 1-919-990-8481 Email: vflax@rti.org
Study Officials:	Simon Kimenju, PhD, MSc Principal Investigator Kula Vyema Centre of Food Economics
Locations:	Kenya
	Kula Vyema Centre of Food Economics Kiambu, Kenya Contact:Contact: Simon Kimenju, PhD, MSc skimenju@gmail.com Contact:Principal Investigator: Simon Kimenju, PhD, MSc Contact:Principal Investigator: Florence Kyallo, PhD, MSc Contact:Principal Investigator: Valerie Flax, PhD, MPH

IPDSharing


Plan to Share IPD:	Yes Dataset will be shared through Nesstar.
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL:

References


Citations:
Links:
Available IPD/Information: