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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455215
Other study ID # 297248
Secondary ID OT2HL156812
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2025
Est. completion date March 1, 2028

Study information

Verified date June 2024
Source University of Arkansas
Contact Pebbles Fagan, PhD, MPH
Phone 301-802-7735
Email pfagan@uams.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 18-85 living in low resource and African American communities. Gardens will be randomized to the intervention (n=3 gardens) or control group (delayed intervention, n=3 gardens). Participants will be assigned to one of six 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.


Description:

Food insecurity is a major cause of chronic diseases and is highest in the nation in Arkansas. Evidence shows that community gardens and healthy cooking demonstration can reduce food insecurity by 1) increasing access to healthy foods and 2) promoting healthy food consumption. Community garden participation is one factor that can influence healthy food consumption such as fruit and vegetable intake. 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 18-85 living in low resource and African American communities. Participants will be assigned to one of six 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. Three of the gardens will be randomized to the intervention group and three to the delayed intervention group. To assess the effects of the intervention, participants will receive a baseline, 8-week, and 6-month survey. Other measures that we will examine include food security; sociodemographics; physical activity; life satisfaction; perceived stress; neighborhood collective efficacy; self-efficacy; individual level social determinants of health; community engagement; and knowledge, attitudes, and satisfaction related to gardening and cooking.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 138
Est. completion date March 1, 2028
Est. primary completion date July 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Arkansas resident aged 18-85; 2. live in community within 1 mile radius of a participating garden; 3. speak English; 4. willingness to participate in the garden as a volunteer during the study intervention period; 5. not previously participated in the garden as a volunteer; 6. participate in 1 of 3 federally qualified programs ( Supplemental Nutrition Assistance Program (SNAP), National School program, Women, Infant and Children (WIC) OR has household income less than $25,000 per year; 7. 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); 8. written informed consent; 9. working phone, home address, and email; 10. willingness to complete all survey assessments. Exclusion Criteria: - Does not live within 1 mile radius of a participating garden.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Community garden activities
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 year after the intervention group.

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
University of Arkansas Coalition for a Tobacco Free Arkansas, National Heart, Lung, and Blood Institute (NHLBI), University of Hawaii Cancer Research Center

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Access to healthy foods We will use the the Perceived Availability of the Healthy Food Scale. Participants will be asked to think of the neighborhood area (1 mile radius) and the extent to which they feel that the foods are of high quality, available, and are low fat. From baseline to 8 weeks (end of intervention) and 6-months post intervention
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