NCT06455215

Brief Summary

The goals of this community-based clinical trial are to examine the association between community garden participation and 1) fruit and vegetable intake (primary outcome) and 2) access to healthy food (secondary outcome) among adults aged 18-95 living in low resource communities. Gardens will be randomized to the intervention (n=4 gardens) or control group (delayed intervention, n=3 gardens). Participants will be assigned to one of seven community gardens to receive an 8-week intervention. During the intervention, participants will be asked to volunteer in the garden, participate in garden social activities, participate in healthy cooking demonstrations and educational sessions. Participants will receive educational materials as well. To assess the effects of the intervention, participants will receive a baseline, 8-week, and 6-month survey. Outcome measures will be compared between the intervention and control groups.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Jul 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jul 2025Mar 2028

First Submitted

Initial submission to the registry

June 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

January 21, 2026

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

June 6, 2024

Last Update Submit

January 20, 2026

Conditions

Keywords

food security, community gardens, fruit/vegetable consumption

Outcome Measures

Primary Outcomes (1)

  • Fruit and vegetable intake

    We will use the five factor screener that is used to approximate intake of fruit juices, fruit, green leafy vegetables, other vegetables, tomato-based sauces, potatoes, and beans

    From baseline to 8 weeks (end of intervention) and 6-months post intervention

Secondary Outcomes (1)

  • Access to healthy foods

    From baseline to 8 weeks (end of intervention) and 6-months post intervention

Study Arms (2)

Garden intervention

EXPERIMENTAL

The gardens in the intervention group will receive an 8-week intervention that includes 1) educational materials, 2) healthy cooking demonstrations, food and transportation support and 3) garden social activities.

Behavioral: Community garden activities

Delayed intervention

ACTIVE COMPARATOR

The control group will be asked to abstain from intervention activities during the 8 week period. The control group will receive the delayed 8-week intervention one month after the intervention group.

Behavioral: Community garden activities

Interventions

The gardens in the intervention group will receive an 8-week intervention that includes 1) educational materials, 2) healthy cooking demonstrations, food and transportation support and 3) garden social activities. The control group will be asked to abstain from intervention activities. The control group will receive the delayed 8-week intervention one month after the intervention group.

Delayed interventionGarden intervention

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arkansas resident aged 18-95;
  • live in community within 1 mile radius of a participating garden;
  • speak English;
  • willingness to participate in the garden as a volunteer during the study intervention period;
  • not previously participated in the garden as a volunteer in past 6 months;
  • scores as food insecure on 1 of any of the food security measures (i.e. food did not last, could not eat balanced meal, cut the size or skip meals and frequency at which this happens, eat less than you think you should, were hungry but did not eat);
  • written informed consent;
  • working phone, home address, and email;
  • \) willingness to complete all survey assessments.

You may not qualify if:

  • Does not live within 1 mile radius of a participating garden.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Study Officials

  • Pebbles Fagan, PhD, MPH

    UAMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pebbles Fagan, PhD, MPH

CONTACT

Elizabeth Taylor, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomization will occur at the garden level. Four gardens will be randomized to the intervention and three gardens to the control group. The participants assigned to the four gardens in the intervention group will receive an 8-week intervention that includes 1) educational materials, 2) healthy cooking demonstrations, 3) food and transportation support and 4) garden social activities. The control garden group will not receive an intervention during this time period which allows us to evaluate differences in the primary and secondary outcomes in the intervention and control groups at 8 weeks and 6 months. The control group will receive the delayed 8-week intervention one month after the intervention group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

July 15, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

March 1, 2028

Last Updated

January 21, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

To facilitate data use, the research projects will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats and dictionaries as well as for variable names, descriptions, and labels. We will share all variable de-identified data following the publication of our final results.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be made available approximately 1 year after the completion of the study, which is approximately when the final results will be published. ICPSR stores data indefinitely.
Access Criteria
The data are publicly available via ICPSR.

Locations