NCT03266120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

August 24, 2017

Last Update Submit

June 4, 2018

Conditions

AnxietyDepressionHealthyMood DisturbanceStressQuality of LifePhysical ActivitySocial Interaction

Keywords

GardeningTherapeutic ArtsTherapeutic HorticultureAnxietyDepressionMood StatesQuality of LifeSocial InteractionsStressWellness

Outcome Measures

Primary Outcomes (2)

  • Biometric Changes in Heart Rate

    Heart rate will be monitored using a portable electronic wrist cuff monitor. Participant heart rate will be measured at the beginning and end of each Individual treatment session, and before the beginning and after the completion of the entire treatment interventions.

    Baseline, up to 5 weeks

  • Biometric Changes in Blood Pressure

    Blood pressure will be monitored using a portable electronic wrist cuff blood pressure monitor that records systolic and diastolic pressure. Participant blood pressure measurements will be recorded before and after each individual treatment session, and before the beginning and after the completion of the entire treatment interventions.

    Baseline, up to 5 weeks

Secondary Outcomes (6)

  • Biometric Changes in Overall Health Status

    Baseline, up to 5 weeks

  • Biometric Changes in Depressive Symptomatology

    Baseline, up to 5 weeks

  • Biometric Changes in State Anxiety

    Baseline, up to 5 weeks

  • Biometric Changes in Mood States

    Baseline, up to 5 weeks

  • Biometric Changes in Perceived Stress

    Baseline, up to 5 weeks

  • +1 more secondary outcomes

Study Arms (2)

Art Intervention

ACTIVE COMPARATOR

Participants randomly assigned to this arm will receive a hands-on art intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place indoors over a period of four weeks for a total of eight art sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.

Other: Art

Gardening Intervention

EXPERIMENTAL

Participants randomly assigned to this arm will receive a hands-on gardening intervention that will consist of twice weekly group sessions of approximately 60 minutes each in duration that will take place in a greenhouse over a period of four weeks for a total of eight gardening sessions. Participants will complete sets of self-report psychometric assessments and blood pressure and heart rate will be monitored before, during, and following the conclusion of the intervention.

Other: Gardening

Interventions

ArtOTHER

Participants will receive a hands-on art activities intervention consisting of two art activities sessions each week lasting approximately 60 minutes each in duration for four weeks for a total of eight sessions. Art activities will include hand papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the art intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the art intervention.

Art Intervention
GardeningOTHER

Participants will receive a hands-on gardening intervention consisting of two gardening sessions each week lasting approximately 60 minutes each in duration for four weeks, for a total of eight sessions. Gardening activities will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the gardening intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the gardening intervention.

Also known as: Horticulture, People-Plant Interactions
Gardening Intervention

Eligibility Criteria

Age26 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women
  • years of age
  • Not pregnant
  • Non-gardener
  • Non-artist
  • Non-smoker
  • Good Health
  • Able to participate in all aspects of the study, including working with plants.

You may not qualify if:

  • Uncomfortable in close spaces (claustrophobia)
  • Allergies to plants
  • Allergies to plant parts like pollen
  • Allergies to plant-based foods
  • No additions to alcohol or to recreational drugs or prescription medications
  • Not suffering from recurring pain, and
  • No diseases, disorders or disabilities that affect daily life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fifield and Merhof Halls

Gainesville, Florida, 32611, United States

Location

Wilmot Gardens Conference Center and Greenhouse

Gainesville, Florida, 32611, United States

Location

Related Publications (9)

  • Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

    PMID: 1593914BACKGROUND

  • Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

    PMID: 8275167BACKGROUND

  • Beck, AT, Steer RA, Garbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical Psychology Review 1988 (8):77-100.

    BACKGROUND

  • Spielberger, CD, Gorsuch RL, Lushene R. The State-Trait Personality Inventory STAI-Y, form Y. Consulting Psychologists Press, Palo Alto. 1983

    BACKGROUND

  • McNair PM, Lorr M, Droppleman LF. POMS manual (2nd ed.). San Diego: Educational and Industrial Testing Service. 1981.

    BACKGROUND

  • Shacham S. A shortened version of the Profile of Mood States. J Pers Assess. 1983 Jun;47(3):305-6. doi: 10.1207/s15327752jpa4703_14.

    PMID: 6886962BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Hahn EA, Beaumont JL, Pilkonis PA, Garcia SF, Magasi S, DeWalt DA, Cella D. The PROMIS satisfaction with social participation measures demonstrated responsiveness in diverse clinical populations. J Clin Epidemiol. 2016 May;73:135-41. doi: 10.1016/j.jclinepi.2015.08.034. Epub 2016 Feb 27.

    PMID: 26931288BACKGROUND

  • Odeh R, Diehl ERM, Nixon SJ, Tisher CC, Klempner D, Sonke JK, Colquhoun TA, Li Q, Espinosa M, Perdomo D, Rosario K, Terzi H, Guy CL. A pilot randomized controlled trial of group-based indoor gardening and art activities demonstrates therapeutic benefits to healthy women. PLoS One. 2022 Jul 6;17(7):e0269248. doi: 10.1371/journal.pone.0269248. eCollection 2022.

    PMID: 35793277DERIVED

MeSH Terms

Conditions

Anxiety DisordersDepressionMotor Activity

Interventions

Reproductive Techniques, AssistedGardeningHorticulture

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Reproductive TechniquesTherapeuticsInvestigative TechniquesAgricultureTechnology, Industry, and Agriculture

Study Officials

  • Charles L Guy, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2017

First Posted

August 29, 2017

Study Start

August 3, 2017

Primary Completion

November 9, 2017

Study Completion

January 15, 2018

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)