Vegetables for All Evaluation Kenya
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ClinicalTrials.gov Identifier: NCT05992376 |
Recruitment Status :
Active, not recruiting
First Posted : August 15, 2023
Last Update Posted : April 22, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | August 8, 2023 | ||||
First Posted Date ICMJE | August 15, 2023 | ||||
Last Update Posted Date | April 22, 2024 | ||||
Actual Study Start Date ICMJE | November 20, 2023 | ||||
Actual Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Vegetables for All Evaluation Kenya | ||||
Official Title ICMJE | Impact Evaluation of the Global Alliance for Improved Nutrition (GAIN) Vegetables for All Program in Kenya | ||||
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). |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: 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. Masking: None (Open Label)Primary Purpose: Other |
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Condition ICMJE | Vegetable Consumption | ||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
4680 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | October 31, 2025 | ||||
Actual Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Household Surveys Inclusion Criteria:
Mama Mboga Surveys Inclusion Criteria:
In-depth interviews with value chain actors Inclusion criteria:
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:
FGDs with mama mbogas Inclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Kenya | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05992376 | ||||
Other Study ID Numbers ICMJE | 424604 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Valerie Flax, RTI International | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | RTI International | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | RTI International | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |