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Completed

NCT Number: NCT03089151

Denver Garden Environment and Microbiome Study Disease

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.

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Key information

Conditions

Diet Modification Behavior Body Weight Body Weight Changes Chronic Disease Disease Attributes Health Behavior Lifestyle, Sedentary Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Activity Sedentary Behavior Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Boulder

Boulder, Colorado, 80303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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 outcomes

  1. Change in fruit and vegetable intake from baseline at 20 weeks

    Time frame: Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)

    6 24-hour diet recalls will be collected at random

  2. Change in sedentary time behavior from baseline at 20 weeks

    Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)

    Accelerometers will be adhered to thigh and collect data for 7 days

  3. Change in bacterial load from baseline at 20 weeks

    Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)

    Microbiome data will be collected six time points using 1 gut, 2 skin, and 1 oral samples

  4. Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks

    Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)

    Accelerometers will be adhered to thigh and collect data for 7 days

  5. Change in weight (kg) from baseline at 20 weeks

    Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)

    Objective measurements of weight will be collected

  6. Change in waist circumference from baseline at 20 weeks

    Time frame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)

    Objective measurement of waist circumference

  7. Change in pathogenic taxa from baseline at 20 weeks

    Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)

    Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples

  8. Change in taxonomic diversity from baseline at 20 weeks

    Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)

    Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples

  9. Change in relative dominance from baseline at 20 weeks

    Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)

    Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples

  10. Change in indicator taxa from baseline at 20 weeks

    Time frame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)

    Microbiome data will be derived from 1 gut, 2 skin, and 1 oral samples

  11. Change in Inflammatory biomarkers from baseline at 20 weeks

    Time frame: 20 weeks

    Samples include hs-CRP, TNF-alpha, IL1b, IL4, IL6, IL10

Secondary outcomes

  1. Change in HbA1C from baseline at 20 weeks

    Time frame: 20 weeks

  2. Change in blood pressure from baseline at 20 weeks

    Time frame: 20 weeks

  3. Change in lipid profile from baseline at 20 weeks

    Time frame: 20 weeks

    Including LDL, HDL, total cholesterol, triglycerides

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

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

Acronym: DGEM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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