CancerCAPsNCT03089177
Community Activation for Prevention (CAPs): A Study of Community Gardening
A study testing Community Garden Intervention in people with Cancer and Obesity, run by University of Colorado, Boulder at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Obesity, Lifestyle, Sedentary
- What is being tested?
- Community Garden Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Is not able to complete the study requirements in Spanish or English
- Aged 17 or younger
- Has gardened in the past 2 gardening seasons
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80303
About this study
Official title: 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.
- Conditions
- Cancer, Obesity, Lifestyle, Sedentary, Physical Activity, Health Behavior, Chronic Disease
- Being tested
- Community Garden Intervention
- Keywords
- Randomized Controlled Trial, Community Gardening, Health Behavior Change, Physical Activity, Diet, Obesity, Cancer Prevention, Neighborhood
- Medical subject headings
- Neoplasms, Obesity, Sedentary Behavior, Motor Activity, Health Behavior, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Garden InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks
9 24-hour diet recalls will be collected randomly
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Validated scale of perceived stress will be completed
Measured: 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start1 Jan 2017
- Primary completion30 Jul 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University, Colorado School of Public Health, University of South Carolina, Colorado State University, Denver Urban Gardens
- Responsible party
- Principal investigator, Jill Litt, University of Colorado, Boulder
- Investigators
- Jill S Litt, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089177
- Sponsor's protocol ID
- 16-0644
- Acronym
- CAPs
- Status last verified
- May 2021
- First submitted
- 17 Feb 2017
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38871715Alaimo 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.
PubMed 37215644Litt 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.
PubMed 36608945Villalobos 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.
PubMed 31799473Litt 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.
PubMed 29563043
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Activation for Prevention (CAPs): A Randomized Controlled Trial of Community Gardening
- ClinicalTrials.gov ID
- NCT03089177
- Acronym / sponsor ID
- CAPs / 16-0644
- Conditions
- Cancer, Obesity, Lifestyle, Sedentary, Physical Activity, Health Behavior, Chronic Disease
- Keywords
- Randomized Controlled Trial, Community Gardening, Health Behavior Change, Physical Activity, Diet, Obesity, Cancer Prevention, Neighborhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 296 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Michigan State University, Colorado School of Public Health, University of South Carolina, Colorado State University, Denver Urban Gardens
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Garden Intervention Group | Experimental | Behavioral: Community Garden InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Is not able to complete the study requirements in Spanish or English
- Aged 17 or younger
- Has gardened in the past 2 gardening seasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Garden InterventionThe 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. | Behavioural | Community Garden Intervention Group |
Primary outcome
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
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
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
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
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)
Accelerometers will be adhered to thigh and collect data for 7 days
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)
Measurement of waist circumference (cm)
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
1 secondary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 38871715Coringrato 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.
- Derived from this study: PubMed 37215644Alaimo 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.
- Derived from this study: PubMed 36608945Litt 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.
- Derived from this study: PubMed 31799473Villalobos 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.
- Derived from this study: PubMed 29563043Litt 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill S Litt, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Garden Intervention in people with Cancer and Obesity, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03089177, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.