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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03089151
Other study ID # 16-0138, 16-0424
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2016
Est. completion date December 30, 2017

Study information

Verified date May 2021
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 30, 2017
Est. primary completion date December 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
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: 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.

Locations

Country Name City State
United States University of Colorado Boulder Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fruit and vegetable intake from baseline at 20 weeks 6 24-hour diet recalls will be collected at random Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)
Primary Change in sedentary time behavior from baseline at 20 weeks Accelerometers will be adhered to thigh and collect data for 7 days 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Primary 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 Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Primary 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 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Primary Change in weight (kg) from baseline at 20 weeks Objective measurements of weight will be collected 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Primary Change in waist circumference from baseline at 20 weeks Objective measurement of waist circumference 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Primary Change in pathogenic taxa from baseline at 20 weeks Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Primary Change in taxonomic diversity from baseline at 20 weeks Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Primary Change in relative dominance from baseline at 20 weeks Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Primary Change in indicator taxa from baseline at 20 weeks Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Primary Change in Inflammatory biomarkers from baseline at 20 weeks Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10 20 weeks
Secondary Change in HbA1C from baseline at 20 weeks 20 weeks
Secondary Change in blood pressure from baseline at 20 weeks 20 weeks
Secondary Change in lipid profile from baseline at 20 weeks Including LDL, HDL, total cholesterol, triglycerides 20 weeks
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