Denver Garden Environment and Microbiome Study Disease (DGEM)

University of Colorado Boulder (CU)

Status: Completed

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

Treatments: Behavioral: Community Garden Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03089151

16-0138, 16-0424

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups

Community Garden Intervention Group

Experimental group

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

Treatment:

Behavioral: Community Garden Intervention

Wait List Control Group

No Intervention group

Description:

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