Viewing Study NCT03266120


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Study NCT ID: NCT03266120
Status: COMPLETED
Last Update Posted: 2018-06-06
First Post: 2017-08-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Health Benefits of Gardening
Sponsor: University of Florida
Organization:

Study Overview

Official Title: Assessing Human Health Benefits of Gardening
Status: COMPLETED
Status Verified Date: 2018-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The objective of the research is to test the hypothesis that participating in group-based gardening or group-based art activities may alter the mental health and cardiac physiological status of a wellness population of women ages 26-49. Assessment of the effects of gardening or art activities on the experimental population will take two approaches, the first being the use of physiological measurements of heart rate and blood pressure. The second approach will employ six widely used and well-established self-reported assessment instruments that will capture information about the health and well-being of participants. These measurements and assessments will provide a psychometrically-based before and after mental health status and between treatments health summaries of the participants in the gardening group and those engaged in the art group activities.
Detailed Description: The goal of this project is to better understand how interacting and working with plants in a group gardening activities program in a greenhouse, or a group art program that takes place indoors and is devoid of images or depictions of plants influences the overall health and well-being of participants.

A total anticipated study population (N = 40) will consist of up to 20 healthy women randomly assigned to the art activities group, and up to 20 healthy women assigned to the gardening group. There will be measurements of heart rate, systolic and diastolic blood pressure, and psychometric assessments including satisfaction of social activities at baseline and post intervention. Heart rate and blood pressure measurements will be taken at the beginning and end of each of the eight gardening or arts sessions. Psychometric assessments of study participants will be conducted at baseline and post-intervention. Each treatment group will be divided into two smaller groups of up to ten women each that will receive the gardening or art interventions on different days of the week. The participants in the gardening or art groups will receive an experimental intervention consisting of 8 gardening or art sessions, each approximately 60 minutes in duration over a four week treatment period. Gardening and art sessions will take place at the same time of day twice each week, and follow a standardized programming sequence to ensure equivalency of intervention across all sessions. Ambient environmental conditions in the greenhouse during the gardening sessions will be monitored and recorded. The gardening activities will emphasize growing plants from seeds, plant propagation techniques, transplanting, and plant-mediated taste, visual, olfactory and touch sensory stimulation. All gardening sessions will begin with a short educational module introducing the plants and gardening activities taking place during each session. Art activities will include papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing, and begin with a short educational module of the activity.

In addition to the pre- and post-intervention assessments and measurement, psychometric assessments will be administered for depression symptomatology, mood states and perceived stress at specific points during the gardening and art activities to evaluate any changes over time resulting from the interventions. Participant heart rate and blood pressure measurements will be made at the beginning and at the end of all gardening and art sessions.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: