- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277583
Urban Care Farming on Living Well and Productive Engagement of Older Adults
Effects of Urban Care Farming on Promoting Wellbeing and Productive Engagement for Older Adults: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The data collection consists of three sessions, before and after the 24-week intervention program, and 6 months post-intervention. Prior to the data collection, participants will be assessed for eligibility criteria and explained the detailed study procedures by trained research staff for informed consent. After completing the written informed consent, participants will be interviewed using detailed questionnaires relating to their health, nutrition, and dietary status, psychosocial measures, and undergo a series of physical examinations. These examinations include physical performance tests of mobility and gait, balance and strength, body measurements of weight, height, body mass index (BMI), waist-hip circumference, mid-upper-arm and calf circumference, blood pressure, and blood tests that will examine participants' clinical profile, biomarkers, and immunoassays. Participants will also be given Fitbit trackers to determine if they have improved their physical activity. Last, data collected will also include Functional near-infrared spectroscopy (fNIRS), a non-invasive procedure to determine the oxygenation levels of participants at rest and while doing some thinking activities. This data collection procedure will be conducted at baseline before the intervention and after the completion of the intervention.
The intervention will include a weekly, 24-week urban farming program. Each weekly session is where participants will engage in outdoor and indoor horticultural activities ranging from fertilization, sowing, and watering, to transplanting, maintaining, and harvesting vegetables and herbs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cynthia Chen, PhD
- Phone Number: 66015526
- Email: cynchen@nus.edu.sg
Study Contact Backup
- Name: Jocelin Lam
- Phone Number: 66013343
- Email: jocelinl@nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 117549
- Recruiting
- NUS
-
Contact:
- Ezra Chiam
- Phone Number: +6566016036
- Email: ezra.chiam@nus.edu.sg
-
Principal Investigator:
- Cynthia Chen, PhD
-
Sub-Investigator:
- Choon Nam Ong, MD, PhD
-
Sub-Investigator:
- Schwarz Herbert, PhD
-
Sub-Investigator:
- Mary Chong, PhD
-
Sub-Investigator:
- Roger Ho, PhD
-
Sub-Investigator:
- Leng Leng Theng, PhD
-
Singapore, Singapore, 618661
- Recruiting
- Jurong Lake Garden
-
Contact:
- Joan Hung
- Email: Joan_HUNG@nparks.gov.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 50 and 80
- Reside in Singapore
- Willing to take part in the intervention
- Agree for their data to be used for research purposes
- Ambulant and able to carry out some tasks independently
Exclusion Criteria:
- Not willing to participate in the data collection (participants can opt not to answer some questions in the questionnaire but have to consent to the other data collection methods, e.g., Blood taking/test)
- Refusal to give informed consent
- Unable to give consent independently
- Have a disability of the upper or lower body that limits their mobility
- Have medical conditions which in the opinion of the research/investigative team that would compromise (or interfere with) their ability to participate in the study
- Had a recent severe medical episode (e.g., heart attack)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Urban Care farming Intervention
This intervention group of participants will receive the experimental urban care farming treatment.
|
An intervention curriculum has been designed using horticulture therapy combined with urban farming techniques.
The sessions will use plants and interaction with nature to engage and rehabilitate participants.
Both the intervention and control group participants will undergo the intervention.
But the intervention group will start with the urban care farming intervention first, and the control group will follow once the intervention group completes the program.
|
Other: Waitlist control
Waitlist control group consists of participants who do not receive the experimental treatment, but who are put on a waiting list to receive the intervention after the active treatment group does.
|
An intervention curriculum has been designed using horticulture therapy combined with urban farming techniques.
The sessions will use plants and interaction with nature to engage and rehabilitate participants.
Both the intervention and control group participants will undergo the intervention.
But the intervention group will start with the urban care farming intervention first, and the control group will follow once the intervention group completes the program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHO Quality of Life Scale (WHOQOL-BREF)
Time Frame: Baseline, 6 months, 12 months
|
Brief version consisting of 26 QOL related questions developed by World Health Organisation.
There are four domains, Physical, Psychological, Social relationships, and Environment.
The minimum and maximum for each domain is 0 and 100 respectively, with higher scores being better outcome for each domain.
|
Baseline, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immuno-biomarkers: IL-1RA, IL-6, IL-8 (CXCL8), IL-10, IL-13, IL-17A (CTLA-8), MIP-3 beta (CCL19), SDF-1 alpha, MMP-3, MMP-9, MCP-1 (CCL2), and TNF alpha
Time Frame: Baseline, 6 months
|
changes in concentration of cytokines, chemokines and selected ageing and inflammatory markers in measured in pg/mL
|
Baseline, 6 months
|
Brief sense of community scale (BSCS)
Time Frame: Baseline, 6 months, 12 months
|
8-items measuring the dimensions of needs fulfillment, group membership, influence, and emotional connection.
Composite scores with the average of the 8 items is computed, min 1 and max.
8, with higher scores showing greater sense of community.
|
Baseline, 6 months, 12 months
|
Fried phenotype of frailty
Time Frame: Baseline, 6 months, 12 months
|
Fried frailty phenotype (FP) assesses physical frailty through five criteria: unintentional weight loss; weakness or poor handgrip strength; self-reported exhaustion; slow walking speed; and low physical activity.
Total scores are classified into 3 categories: non-frail, pre-frail, and frail.
|
Baseline, 6 months, 12 months
|
Lubben social network scale (LSNS-6)
Time Frame: Baseline, 6 months, 12 months
|
This scale measure of social engagement including family and friends, min score of 6 and max.
score of 30.
A higher score indicating more social engagement and a cutoff of 12 points indicate risk of social isolation.
|
Baseline, 6 months, 12 months
|
Functional near-infrared spectroscopy
Time Frame: Baseline, 6 months
|
Brain oxygenation levels measured in cerebral metabolic rate of oxygen (CMRO^2).
|
Baseline, 6 months
|
EQ5D
Time Frame: Baseline, 6 months, 12 months
|
EQ5D-5L, a measure that consists five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
An utility score can be attached to the total score to determine the cost utility of the participants' quality of life.
An utility score between 0 to 1 on the Singapore population will be derived.
|
Baseline, 6 months, 12 months
|
Geriatric anxiety scale (GAS-10)
Time Frame: Baseline, 6 months, 12 months
|
Geriatric anxiety scale that measures older adults' self-reported anxiety.
Minimum score is 0 and maximum of 30.
The higher the score, the more anxious.
|
Baseline, 6 months, 12 months
|
MOCA
Time Frame: Baseline, 6 months, 12 months
|
Participants are scored following MOCA scoring criteria.
Max. 30 points.
Scores lower than 26 showed signs of cognitive impairment.
|
Baseline, 6 months, 12 months
|
Brief resilience scale
Time Frame: Baseline, 6 months, 12 months
|
Resilience scale on a 5 points scale, strongly disagree to strongly agree, the higher the score, the greater resilience.
|
Baseline, 6 months, 12 months
|
De jong Gierveld loneliness scale
Time Frame: Baseline, 6 months, 12 months
|
Measures emotional and/or social loneliness situation of respondents and adds up to a total loneliness score.
the total loneliness score can be categorized into four levels: not lonely (score 0, 1 or 2), moderate lonely (score 3 through 8), severe lonely (score 9 or 10), and very severe lonely (score 11).
|
Baseline, 6 months, 12 months
|
Fitbit
Time Frame: Continuous for 12 months
|
Steps count
|
Continuous for 12 months
|
Body weight and height
Time Frame: Baseline, 6 months, 12 months
|
Measured in kilograms and metres respectively.
Weight and height will be combined to report BMI in kg/m^2
|
Baseline, 6 months, 12 months
|
Fasting plasma glucose, HbA1c
Time Frame: Baseline, 6 months
|
measures average blood sugar levels over the past 3 months
|
Baseline, 6 months
|
Serum Creatinine
Time Frame: Baseline, 6 months
|
measures the level of creatinine in the blood
|
Baseline, 6 months
|
Attitude towards eating healthy food
Time Frame: Baseline, 6 months, 12 months
|
Attitude of healthy eating (11-items) adapted from Saba et al 2019 (DOI: 10.1016/j.foodqual.2018.11.017).
Composite score computed from the averaged measures will have a min of 1 and max of 5.
|
Baseline, 6 months, 12 months
|
Waist and hip circumference
Time Frame: Baseline, 6 months, 12 months
|
Measured in centimetres
|
Baseline, 6 months, 12 months
|
Blood pressure
Time Frame: Baseline, 6 months, 12 months
|
Measured in systolic and diastolic
|
Baseline, 6 months, 12 months
|
Lipid panel
Time Frame: Baseline, 6 months
|
A lipid panel measures levels of various types of lipids (fats) in the blood.
Measures HDL cholesterol (High-Density Lipoprotein) and LDL cholesterol (Low-Density Lipoprotein) and Triglycerides
|
Baseline, 6 months
|
Eating fruits and vegetables behavior
Time Frame: Baseline, 6 months, 12 months
|
Behavior (8-items) towards eating fruits and vegetables developed for this study.
Max.
score of 10 and minimum score of 2 will be derived from this measurement.
|
Baseline, 6 months, 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cynthia Chen, PhD, National University of Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUS-IRB-2023-191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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