Spots Global Cancer Trial Database for Denver Garden Environment and Microbiome Study Disease

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Trial Identification

Brief Title: Denver Garden Environment and Microbiome Study Disease

Official Title: A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart

Study ID: NCT03089151

Conditions

Interventions

Community Garden Intervention

Study Description

Brief 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. 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.