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Denver Garden Environment and Microbiome Study Disease (DGEM)

Primary Purpose

Diet Modification, Physical Activity, Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Garden Intervention
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diet Modification focused on measuring Pilot Randomized Controlled Trial, Community Garden, Health Behavior Change, Physical Activity, Diet, Obesity, Neighborhood, Microbiome, Inflammatory biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Colorado Boulder

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Community Garden Intervention Group

Wait List Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in fruit and vegetable intake from baseline at 20 weeks
6 24-hour diet recalls will be collected at random
Change in sedentary time behavior from baseline at 20 weeks
Accelerometers will be adhered to thigh and collect data for 7 days
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
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
Change in weight (kg) from baseline at 20 weeks
Objective measurements of weight will be collected
Change in waist circumference from baseline at 20 weeks
Objective measurement of waist circumference
Change in pathogenic taxa from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in taxonomic diversity from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in relative dominance from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in indicator taxa from baseline at 20 weeks
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Change in Inflammatory biomarkers from baseline at 20 weeks
Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10

Secondary Outcome Measures

Change in HbA1C from baseline at 20 weeks
Change in blood pressure from baseline at 20 weeks
Change in lipid profile from baseline at 20 weeks
Including LDL, HDL, total cholesterol, triglycerides

Full Information

First Posted
February 17, 2017
Last Updated
May 4, 2021
Sponsor
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT03089151
Brief Title
Denver Garden Environment and Microbiome Study Disease
Acronym
DGEM
Official Title
A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification, Physical Activity, Weight Gain, Chronic Disease, Lifestyle, Sedentary, Health Behavior
Keywords
Pilot Randomized Controlled Trial, Community Garden, Health Behavior Change, Physical Activity, Diet, Obesity, Neighborhood, Microbiome, Inflammatory biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Community Garden Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
The non-gardening group will remain on the DUG wait lists and will not receive the garden intervention.
Intervention Type
Behavioral
Intervention Name(s)
Community Garden Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fruit and vegetable intake from baseline at 20 weeks
Description
6 24-hour diet recalls will be collected at random
Time Frame
Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)
Title
Change in sedentary time behavior from baseline at 20 weeks
Description
Accelerometers will be adhered to thigh and collect data for 7 days
Time Frame
2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Title
Change in bacterial load from baseline at 20 weeks
Description
Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples
Time Frame
Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Title
Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks
Description
Accelerometers will be adhered to thigh and collect data for 7 days
Time Frame
2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Title
Change in weight (kg) from baseline at 20 weeks
Description
Objective measurements of weight will be collected
Time Frame
2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Title
Change in waist circumference from baseline at 20 weeks
Description
Objective measurement of waist circumference
Time Frame
2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
Title
Change in pathogenic taxa from baseline at 20 weeks
Description
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Time Frame
Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Title
Change in taxonomic diversity from baseline at 20 weeks
Description
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Time Frame
Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Title
Change in relative dominance from baseline at 20 weeks
Description
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Time Frame
Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Title
Change in indicator taxa from baseline at 20 weeks
Description
Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples
Time Frame
Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
Title
Change in Inflammatory biomarkers from baseline at 20 weeks
Description
Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1C from baseline at 20 weeks
Time Frame
20 weeks
Title
Change in blood pressure from baseline at 20 weeks
Time Frame
20 weeks
Title
Change in lipid profile from baseline at 20 weeks
Description
Including LDL, HDL, total cholesterol, triglycerides
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S Litt, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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