- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089177
Community Activation for Prevention (CAPs): A Study of Community Gardening (CAPs)
Community Activation for Prevention (CAPs): A Randomized Controlled Trial of Community Gardening
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Boulder, Colorado, United States, 80303
- University of Colorado Boulder
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Is not able to complete the study requirements in Spanish or English
- Aged 17 or younger
- Has gardened in the past 2 gardening seasons
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Community Garden Intervention Group
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.
|
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:
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. |
|
No Intervention: Wait List Control Group
Participants randomized to the Wait List Control Group will remain on community gardening waiting lists and will not receive the garden intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks
Time Frame: Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
|
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)
|
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Change in sedentary time from baseline at 20 weeks and 48 weeks
Time Frame: 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
|
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)
|
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Change in fiber Intake from baseline at 20 weeks and 52 weeks
Time Frame: Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
|
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
Time Frame: Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
|
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
Time Frame: 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
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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)
|
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Change in waist circumference from baseline to 20 weeks and 52 weeks
Time Frame: 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
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Measurement of waist circumference (cm)
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3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
|
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Change in weight (kg) from baseline to 20 weeks and 52 weeks
Time Frame: 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
|
Objective measurement of weight will be collected
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3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Perceived Stress from baseline to 20 weeks and 52 weeks
Time Frame: 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
|
Validated scale of perceived stress will be completed
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3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill S Litt, PhD, University of Colorado, Boulder
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-0644
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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