Clinical trial NCT03089151: Denver Garden Environment and Microbiome Study Disease
Official title: A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in fruit and vegetable intake from baseline at 20 weeks
timeFrame: Measurements will occur during weeks 1-2 (3 random recalls) and weeks 18-20 (3 random recalls)
measure: Change in sedentary time behavior from baseline at 20 weeks
timeFrame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
measure: Change in bacterial load from baseline at 20 weeks
timeFrame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
measure: Change in moderate-to-vigorous physical activity (MVPA) from baseline at 20 weeks
timeFrame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
measure: Change in weight (kg) from baseline at 20 weeks
timeFrame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
measure: Change in waist circumference from baseline at 20 weeks
timeFrame: 2 measurements over 6 months, T1 (Week 1) and T6 (Week 20)
measure: Change in pathogenic taxa from baseline at 20 weeks
timeFrame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
measure: Change in taxonomic diversity from baseline at 20 weeks
timeFrame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
measure: Change in relative dominance from baseline at 20 weeks
timeFrame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
measure: Change in indicator taxa from baseline at 20 weeks
timeFrame: Every 3-4 weeks up to 20 weeks (Week 1, Week 4, Week 7, Week 10, Week 14, Week 18)
measure: Change in Inflammatory biomarkers from baseline at 20 weeks
timeFrame: 20 weeks
Secondary outcomes:
measure: Change in HbA1C from baseline at 20 weeks
timeFrame: 20 weeks
measure: Change in blood pressure from baseline at 20 weeks
timeFrame: 20 weeks
measure: Change in lipid profile from baseline at 20 weeks
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Jill S Litt, PhD
role: PRINCIPAL_INVESTIGATOR
References: