NCT03089151|CompletedDMC
Denver Garden Environment and Microbiome Study Disease
DGEM
A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
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DGEM
A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
Sponsor study identifier
interventional
16
1 country
1
Study Start
June 2, 2016
Actual (reported)Primary Completion
December 15, 2017
Actual (reported)Study Completion
December 30, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2, 2016
Actual (reported)February 17, 2017
Actual (reported)March 24, 2017
Actual (reported)December 15, 2017
Actual (reported)December 30, 2017
Actual (reported)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)
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)
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)
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.
The non-gardening group will remain on the DUG wait lists and will not receive the 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Colorado Boulder
Boulder, Colorado, 80303, United States
Jill S Litt, PhD
University of Colorado, Boulder
16 participants (actual enrollment reported by the registry).
First Submitted
February 17, 2017
First Posted
March 24, 2017
Study Start
June 2, 2016
Actual (reported)CalFitness Smartphone-Delivered Physical Activity Intervention With Messaging
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)
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)
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)
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)
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)
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)
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)
Change in Inflammatory biomarkers from baseline at 20 weeks
Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10
20 weeks
Change in HbA1C from baseline at 20 weeks
20 weeks
Change in blood pressure from baseline at 20 weeks
20 weeks
Change in lipid profile from baseline at 20 weeks
20 weeks
Contact the study team to confirm eligibility.
Primary Completion
December 15, 2017
Actual (reported)Study Completion
December 30, 2017
Actual (reported)Last Updated
May 7, 2021
Record last verified: 2021-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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