Denver Garden Environment and Microbiome Study Disease

NCT ID: NCT03089151

Last Updated: 2021-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-02

Study Completion Date

2017-12-30

Brief Summary

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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

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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

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Diet Modification Physical Activity Weight Gain Chronic Disease Lifestyle, Sedentary Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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, including seeds and transplants, tools, new garden classes and access to master community gardeners in Denver.

Group Type EXPERIMENTAL

Community Garden Intervention

Intervention Type BEHAVIORAL

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:

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.

Wait List Control Group

The non-gardening group will remain on the DUG wait lists and will not receive the garden intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Community Garden Intervention

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:

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Jill Litt

Associate Professor, Environmental Studies

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill S Litt, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Locations

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University of Colorado Boulder

Boulder, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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16-0138, 16-0424

Identifier Type: -

Identifier Source: org_study_id

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