Denver Garden Environment and Microbiome Study Disease

Physical Activity Clinical Trial

— DGEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089151
• Other study ID #: 16-0138, 16-0424
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

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

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