search
Back to results

Community Activation for Prevention (CAPs): A Study of Community Gardening (CAPs)

Primary Purpose

Cancer, Obesity, Lifestyle, Sedentary

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Garden Intervention
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer focused on measuring Randomized Controlled Trial, Community Gardening, Health Behavior Change, Physical Activity, Diet, Obesity, Cancer Prevention, Neighborhood

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Colorado Boulder

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community Garden Intervention Group

Wait List Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks
9 24-hour diet recalls will be collected randomly
Change in sedentary time from baseline at 20 weeks and 48 weeks
Accelerometers will be adhered to thigh and collect data for 7 days
Change in fiber Intake from baseline at 20 weeks and 52 weeks
9 24-hour diet recalls will be collected randomly
Change in Healthy Eating Index (HEI) from baseline at 20 weeks and 52 weeks
9 24-hour diet recalls will be collected randomly
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
Change in waist circumference from baseline to 20 weeks and 52 weeks
Measurement of waist circumference (cm)
Change in weight (kg) from baseline to 20 weeks and 52 weeks
Objective measurement of weight will be collected

Secondary Outcome Measures

Change in Perceived Stress from baseline to 20 weeks and 52 weeks
Validated scale of perceived stress will be completed

Full Information

First Posted
February 17, 2017
Last Updated
May 4, 2021
Sponsor
University of Colorado, Boulder
Collaborators
Michigan State University, Colorado School of Public Health, University of South Carolina, Colorado State University, Denver Urban Gardens
search

1. Study Identification

Unique Protocol Identification Number
NCT03089177
Brief Title
Community Activation for Prevention (CAPs): A Study of Community Gardening
Acronym
CAPs
Official Title
Community Activation for Prevention (CAPs): A Randomized Controlled Trial of Community Gardening
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
Collaborators
Michigan State University, Colorado School of Public Health, University of South Carolina, Colorado State University, Denver Urban Gardens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Obesity, Lifestyle, Sedentary, Physical Activity, Health Behavior, Chronic Disease, Diet Modification
Keywords
Randomized Controlled Trial, Community Gardening, Health Behavior Change, Physical Activity, Diet, Obesity, Cancer Prevention, Neighborhood

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Garden Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
Participants randomized to the Wait List Control Group will remain on community gardening waiting lists and will not receive the garden intervention.
Intervention Type
Behavioral
Intervention Name(s)
Community Garden Intervention
Intervention Description
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: A garden plot in a Denver Urban Garden Seeds and plant starts Introductory gardening workshop 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.
Primary Outcome Measure Information:
Title
Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks
Description
9 24-hour diet recalls will be collected randomly
Time Frame
Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
Title
Change in sedentary time from baseline at 20 weeks and 48 weeks
Description
Accelerometers will be adhered to thigh and collect data for 7 days
Time Frame
3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Title
Change in fiber Intake from baseline at 20 weeks and 52 weeks
Description
9 24-hour diet recalls will be collected randomly
Time Frame
Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
Title
Change in Healthy Eating Index (HEI) from baseline at 20 weeks and 52 weeks
Description
9 24-hour diet recalls will be collected randomly
Time Frame
Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
Title
Change in moderate-to-vigorous physical activity (MVPA) from baseline to 20 weeks
Description
Accelerometers will be adhered to thigh and collect data for 7 days
Time Frame
3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Title
Change in waist circumference from baseline to 20 weeks and 52 weeks
Description
Measurement of waist circumference (cm)
Time Frame
3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Title
Change in weight (kg) from baseline to 20 weeks and 52 weeks
Description
Objective measurement of weight will be collected
Time Frame
3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Secondary Outcome Measure Information:
Title
Change in Perceived Stress from baseline to 20 weeks and 52 weeks
Description
Validated scale of perceived stress will be completed
Time Frame
3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S Litt, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
31799473
Citation
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.
Results Reference
derived
PubMed Identifier
29563043
Citation
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.
Results Reference
derived

Learn more about this trial

Community Activation for Prevention (CAPs): A Study of Community Gardening

We'll reach out to this number within 24 hrs