Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03089177
Other study ID # 16-0644
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date June 30, 2021

Study information

Verified date May 2021
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators previous studies show that community gardening is associated with reduction of key health behaviors for cancer prevention in diverse populations. Community gardeners eat more fruits and vegetables per day, are more physically active, and are more likely to avoid age-associated increase in body mass index (BMI). The effect is partially explained by the finding that gardeners are more socially involved, and feel more social support than non-gardeners. The investigators propose a randomized controlled trial to determine whether community gardening improves cancer-preventive behaviors among a multi-ethnic, low-income adult population and elucidate the pathways that shape cancer-preventive behaviors. A randomized controlled trial is needed to demonstrate that the observed behavioral differences are due to the effect of gardening as an intervention rather than self-selection by gardeners.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 296
Est. completion date June 30, 2021
Est. primary completion date July 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Community Garden Intervention
The investigators will recruit prospective adult gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. Individuals 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 Wait List Control group will remain on the community gardening wait lists and will not receive these resources. Duration of the intervention is 1 year.

Locations

Country Name City State
United States University of Colorado Boulder Boulder Colorado

Sponsors (6)

Lead Sponsor Collaborator
University of Colorado, Boulder Colorado School of Public Health, Colorado State University, Denver Urban Gardens, Michigan State University, University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in fruit and vegetable intake from baseline at 20 weeks and 52 weeks 9 24-hour diet recalls will be collected randomly Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
Primary Change in sedentary time from baseline at 20 weeks and 48 weeks Accelerometers will be adhered to thigh and collect data for 7 days 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Primary Change in fiber Intake from baseline at 20 weeks and 52 weeks 9 24-hour diet recalls will be collected randomly Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
Primary Change in Healthy Eating Index (HEI) from baseline at 20 weeks and 52 weeks 9 24-hour diet recalls will be collected randomly Measurements will occur during weeks 1-2 (3 random recalls) and week 20 (3 random recalls) and week 48 (3 random recalls)
Primary Change in moderate-to-vigorous physical activity (MVPA) from baseline to 20 weeks Accelerometers will be adhered to thigh and collect data for 7 days 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Primary Change in waist circumference from baseline to 20 weeks and 52 weeks Measurement of waist circumference (cm) 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Primary Change in weight (kg) from baseline to 20 weeks and 52 weeks Objective measurement of weight will be collected 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
Secondary Change in Perceived Stress from baseline to 20 weeks and 52 weeks Validated scale of perceived stress will be completed 3 measurements over one year, T1 (week 1), T2 (week 20), T3 (week 52)
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2