NCT03089177

Brief Summary

The investigators previous studies show that community gardening is associated with reduction of key health behaviors for cancer prevention in diverse populations. Community gardeners eat more fruits and vegetables per day, are more physically active, and are more likely to avoid age-associated increase in body mass index (BMI). The effect is partially explained by the finding that gardeners are more socially involved, and feel more social support than non-gardeners. The investigators propose a randomized controlled trial to determine whether community gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult population and elucidate the pathways that shape cancer-preventive behaviors. A randomized controlled trial is needed to demonstrate that the observed behavioral differences are due to the effect of gardening as an intervention rather than self-selection by gardeners.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
296

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 7, 2021

Status Verified

May 1, 2021

Enrollment Period

3.6 years

First QC Date

February 17, 2017

Last Update Submit

May 4, 2021

Conditions

Keywords

Randomized Controlled TrialCommunity GardeningHealth Behavior ChangePhysical ActivityDietObesityCancer PreventionNeighborhood

Outcome Measures

Primary Outcomes (7)

  • Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks

    9 24-hour diet recalls will be collected randomly

    Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)

  • Change in sedentary time from baseline at 20 weeks and 48 weeks

    Accelerometers will be adhered to thigh and collect data for 7 days

    3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)

  • Change in fiber Intake from baseline at 20 weeks and 52 weeks

    9 24-hour diet recalls will be collected randomly

    Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)

  • Change in Healthy Eating Index (HEI) from baseline at 20 weeks and 52 weeks

    9 24-hour diet recalls will be collected randomly

    Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)

  • Change in moderate-to-vigorous physical activity (MVPA) from baseline to 20 weeks

    Accelerometers will be adhered to thigh and collect data for 7 days

    3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)

  • Change in waist circumference from baseline to 20 weeks and 52 weeks

    Measurement of waist circumference (cm)

    3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)

  • Change in weight (kg) from baseline to 20 weeks and 52 weeks

    Objective measurement of weight will be collected

    3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)

Secondary Outcomes (1)

  • Change in Perceived Stress from baseline to 20 weeks and 52 weeks

    3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)

Study Arms (2)

Community Garden Intervention Group

EXPERIMENTAL

Participants randomized to the Community Garden Intervention Group will receive the garden intervention. Participants will be assigned a plot for one season and will receive a standard package of services and amenities to support participation in the community garden.

Behavioral: Community Garden Intervention

Wait List Control Group

NO INTERVENTION

Participants randomized to the Wait List Control Group will remain on community gardening waiting lists and will not receive the garden intervention.

Interventions

The investigators will recruit prospective adult gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. Individuals randomized to the garden intervention will receive a standardized garden resource package, which includes the following: 1. A garden plot in a Denver Urban Garden 2. Seeds and plant starts 3. Introductory gardening workshop 4. Social events including garden-specific events and garden mentoring. The Wait List Control group will remain on the community gardening wait lists and will not receive these resources. Duration of the intervention is 1 year.

Community Garden Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Able to give informed consent in English or Spanish
  • Aged 18 or over
  • Currently on the wait list for a new garden
  • Not have gardened in the past 2 gardening seasons

You may not qualify if:

  • Is not able to complete the study requirements in Spanish or English
  • Aged 17 or younger
  • Has gardened in the past 2 gardening seasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80303, United States

Location

Related Publications (5)

  • Coringrato E, Alaimo K, Leiferman JA, Villalobos A, Buchenau H, Decker E, Fahnestock L, Quist P, Litt JS. A process evaluation of a randomized-controlled trial of community gardening to improve health behaviors and reduce stress and anxiety. Sci Rep. 2024 Jun 13;14(1):13620. doi: 10.1038/s41598-024-63889-w.

  • Alaimo K, Beavers AW, Coringrato E, Lacy K, Ma W, Hurley TG, Hebert JR. Community Gardening Increases Vegetable Intake and Seasonal Eating From Baseline to Harvest: Results from a Mixed Methods Randomized Controlled Trial. Curr Dev Nutr. 2023 Apr 15;7(5):100077. doi: 10.1016/j.cdnut.2023.100077. eCollection 2023 May.

  • Litt JS, Alaimo K, Harrall KK, Hamman RF, Hebert JR, Hurley TG, Leiferman JA, Li K, Villalobos A, Coringrato E, Courtney JB, Payton M, Glueck DH. Effects of a community gardening intervention on diet, physical activity, and anthropometry outcomes in the USA (CAPS): an observer-blind, randomised controlled trial. Lancet Planet Health. 2023 Jan;7(1):e23-e32. doi: 10.1016/S2542-5196(22)00303-5.

  • Villalobos A, Alaimo K, Erickson C, Harrall KK, Glueck DH, Buchenau H, Buchenau M, Coringrato E, Decker E, Fahnestock L, Hamman RF, Hebert JR, Hurley TG, Leiferman JA, Li K, Quist P, Litt JS. CAPS on the move: Crafting an approach to recruitment for a randomized controlled trial of community gardening. Contemp Clin Trials Commun. 2019 Nov 8;16:100482. doi: 10.1016/j.conctc.2019.100482. eCollection 2019 Dec.

  • Litt JS, Alaimo K, Buchenau M, Villalobos A, Glueck DH, Crume T, Fahnestock L, Hamman RF, Hebert JR, Hurley TG, Leiferman J, Li K. Rationale and design for the community activation for prevention study (CAPs): A randomized controlled trial of community gardening. Contemp Clin Trials. 2018 May;68:72-78. doi: 10.1016/j.cct.2018.03.005. Epub 2018 Mar 18.

MeSH Terms

Conditions

NeoplasmsObesitySedentary BehaviorMotor ActivityHealth BehaviorChronic Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorDisease AttributesPathologic Processes

Study Officials

  • Jill S Litt, PhD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Environmental Studies

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 24, 2017

Study Start

January 1, 2017

Primary Completion

July 30, 2020

Study Completion

June 30, 2021

Last Updated

May 7, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

The investigators will store all Individual Participant Data in a HIPPA compliant database separate from the study database. All analysis will be conducted on an analytic data set, stripped of indirect and direct identifiers.

Locations