Denver Garden Environment and Microbiome Study Disease

NCT03089151 | Completed DMC

• 1 other identifier: 16-0138, 16-0424
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• 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)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

Community Garden Intervention Group

EXPERIMENTAL

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.

Behavioral: Community Garden Intervention

Wait List Control Group

NO INTERVENTION

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

Interventions

Community Garden Intervention BEHAVIORAL

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.

Community Garden Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Is not able to complete the study requirements in Spanish or English
• Aged 17 or younger
• Has gardened in the past 2 gardening seasons

Sponsors & Collaborators

• University of Colorado, Boulder: lead

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80303, United States

Location

MeSH Terms

Conditions

Motor Activity; Weight Gain; Chronic Disease; Sedentary Behavior; Health Behavior; Obesity

Condition Hierarchy (Ancestors)

Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jill S Litt, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Environmental Studies

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 24, 2017
• Study Start: June 2, 2016
• Primary Completion: December 15, 2017
• Study Completion: December 30, 2017
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)