Diet ModificationDGEMNCT03089151
Denver Garden Environment and Microbiome Study Disease
A study testing Community Garden Intervention in people with Diet Modification and Physical Activity, run by University of Colorado, Boulder at 1 site in United States.
Trial summary
An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Modification, Physical Activity, Weight Gain
- 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2016to 30 Dec 2017
- 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: A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.
Read the detailed description
The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:
Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.
Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.
Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.
Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.
Aim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.
Aim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.
- Conditions
- Diet Modification, Physical Activity, Weight Gain, Chronic Disease, Lifestyle, Sedentary, Health Behavior
- Being tested
- Community Garden Intervention
- Keywords
- Pilot Randomized Controlled Trial, Community Garden, Health Behavior Change, Physical Activity, Diet, Obesity, Neighborhood, Microbiome, Inflammatory biomarkers
- Medical subject headings
- Motor Activity, Weight Gain, Chronic Disease, Sedentary Behavior, Health Behavior, Obesity
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 30 prospective gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. DUG randomly assigns people on each garden wait list to available plots, using a lottery. This creates a natural randomized experiment. Participants 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 non-gardening group will remain on the DUG 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, including seeds and transplants, tools, new garden classes and access to master community gardeners in Denver. Receives: Behavioral: Community Garden Intervention |
| Wait List Control Group | No intervention | The non-gardening group will remain on the DUG wait 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
6 24-hour diet recalls will be collected at random
Measured: Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)
Change in sedentary time behavior from baseline at 20 weeks
Accelerometers will be adhered to thigh and collect data for 7 days
Measured: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Change in bacterial load from baseline at 20 weeks
Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples
Measured: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks
Accelerometers will be adhered to thigh and collect data for 7 days
Measured: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Change in weight (kg) from baseline at 20 weeks
Objective measurements of weight will be collected
Measured: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Change in waist circumference from baseline at 20 weeks
Objective measurement of waist circumference
Measured: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Change in pathogenic taxa from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Measured: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Change in taxonomic diversity from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Measured: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Change in relative dominance from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Measured: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Change in indicator taxa from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Measured: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Change in Inflammatory biomarkers from baseline at 20 weeks
Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10
Measured: 20 weeks
Secondary outcomes (3)
Change in HbA1C from baseline at 20 weeks
Measured: 20 weeks
Change in blood pressure from baseline at 20 weeks
Measured: 20 weeks
Change in lipid profile from baseline at 20 weeks
Including LDL, HDL, total cholesterol, triglycerides
Measured: 20 weeks
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 start2 Jun 2016
- Primary completion15 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- 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
- NCT03089151
- Sponsor's protocol ID
- 16-0138, 16-0424
- Acronym
- DGEM
- 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
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
- A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
- ClinicalTrials.gov ID
- NCT03089151
- Acronym / sponsor ID
- DGEM / 16-0138, 16-0424
- Conditions
- Diet Modification, Physical Activity, Weight Gain, Chronic Disease, Lifestyle, Sedentary, Health Behavior
- Keywords
- Pilot Randomized Controlled Trial, Community Garden, Health Behavior Change, Physical Activity, Diet, Obesity, Neighborhood, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- 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.
An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.
Detailed description
The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:
Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.
Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.
Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.
Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.
Aim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.
Aim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.
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, including seeds and transplants, tools, new garden classes and access to master community gardeners in Denver. |
| Wait List Control Group | No intervention | –The non-gardening group will remain on the DUG wait 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 30 prospective gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. DUG randomly assigns people on each garden wait list to available plots, using a lottery. This creates a natural randomized experiment. Participants 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 non-gardening group will remain on the DUG 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
Time frame: Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)
6 24-hour diet recalls will be collected at random
Change in sedentary time behavior from baseline at 20 weeks
Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Accelerometers will be adhered to thigh and collect data for 7 days
Change in bacterial load from baseline at 20 weeks
Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples
Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks
Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Accelerometers will be adhered to thigh and collect data for 7 days
Change in weight (kg) from baseline at 20 weeks
Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Objective measurements of weight will be collected
Change in waist circumference from baseline at 20 weeks
Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Objective measurement of waist circumference
Change in pathogenic taxa from baseline at 20 weeks
Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in taxonomic diversity from baseline at 20 weeks
Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in relative dominance from baseline at 20 weeks
Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in indicator taxa from baseline at 20 weeks
Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in Inflammatory biomarkers from baseline at 20 weeks
Time frame: 20 weeks
Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10
3 secondary outcomes
Change in HbA1C from baseline at 20 weeks
Time frame: 20 weeks
Change in blood pressure from baseline at 20 weeks
Time frame: 20 weeks
Change in lipid profile from baseline at 20 weeks
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
Related trials for Diet Modification
Not yet recruiting
Cancer Nutrition Study - A Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
Solid Tumor Cancer, Immune-Related Adverse Events
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
SHIFT-TB: Nutrition Intervention and Evaluation
Underweight, Overweight and Obesity
Not yet recruiting
Nutrition Intervention for Older Adults and Research Training
Impaired Mobility
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 Diet Modification and Physical Activity, 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.