Nutritional and Metabolic Diseases

Symptoms and General Pathology

All Conditions

Rare Diseases

Obesity

Body Weight

Weight Gain

Chronic Disease

Disease Attributes

Body Weight Changes

Chronic Graft Versus Host Disease

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.

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

Jill S Litt, PhD

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.

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.

Denver Garden Environment and Microbiome Study Disease

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

6 24-hour diet recalls will be collected at random

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

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

Objective measurements of weight will be collected

Objective measurement of waist circumference

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

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

Including LDL, HDL, total cholesterol, triglycerides

University of Colorado, Boulder

Associate Professor, Environmental Studies

Neoplasms

Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Healthcare providers (n=16-24 participants in 4 focus groups) from MD Anderson Cancer Center (MDACC).

AYAs with primary benign or malignant central nervous system tumors (n=16-24 participants in 4 focus groups) treated at MDACC.

AYAs with primary benign or malignant central nervous system tumors (n=80 patients approached, with n= 40 participants consented and randomized to the intervention (n=20) or usual care control group (n=20)) treated at MDACC, any gender and race, who are ≤1-year post-surgery for a central nervous system tumor.

No intervention involved in this phase of the study

Focus Groups

The intervention is a virtually delivered, 12 weekly group-based active video game-centered lifestyle physical activity intervention (POWER UP) targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors.

Pilot randomized controlled trial

Maria Swartz, MD

We will conduct a two-phase study. The first phase is to adapt and develop an active video game (AVG)-centered lifestyle physical activity (PA) intervention (POWER UP) for adolescents and young adults (AYA) with central nervous system tumors. The second phase is to test the feasibility and preliminary efficacy of a 12-week virtually delivered, group-based active video game-centered lifestyle physical activity intervention on function and quality of life in AYAs (aged 15-39) who are ≤1-year post-surgery for a central nervous system tumor. This population is at very high-risk for steep functional decline.

Objective:

To develop (Aim 1) and test (Aim2, Primary Objective) the feasibility and acceptability of a virtually delivered, group-based active video game-centered lifestyle physical activity intervention targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors. Also, (Aim 2, Secondary Objective) in a pilot randomized trial, compare the physical function, quality of live, and physical activity level between intervention and control groups.

Primary: Feasibility and acceptability of the POWER UP intervention and assessments.

Secondary: Physical function, quality of life (QOL), symptoms, and PA levels as measured at the 12- and 24-week follow ups

. Other endpoints relevant to the primary and secondary objectives: BMI status, dietary intake, Fitbit data (days worn and steps), exercise motivation, basic psychological needs at the 12- and 24-week follow-ups

POWER UP: Participating Online While Exercising to Recover Using Play

PROMIS 29 includes the following domains

* Physical Function (5=without any difficulty, 1=unable to do)
* Anxiety (5=always, 1=never)
* Depression (5=always, 1=never)
* Fatigue (5=very much, 1=not at all)
* Sleep Disturbance (5=very poor, 1=very good)
* Ability to participate in Social Roles and Activities(5=never, 1=always)
* Pain Interference (5=very much, 1=not at all)
* Pain Intensity (10=worst pain imaginable, 0=no pain)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Denver Garden Environment and Microbiome Study Disease	NCT03089151	Diet Modificati... Physical Activi... Weight Gain Chronic Disease Lifestyle, Sede... Health Behavior	Community Garde...	18 Years -	University of Colorado, Boulder
POWER UP: Participating Online While Exercising to Recover Using Play	NCT05308407	Exercise Central Nervous... Tumors	Focus Groups Pilot randomize...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pilot randomized controlled trial