Urban Care Farming on Living Well and Productive Engagement of Older Adults

Stress, Psychological Clinical Trial

Official title:

Effects of Urban Care Farming on Promoting Wellbeing and Productive Engagement for Older Adults: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06277583
• Other study ID #: NUS-IRB-2023-191
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: National University of Singapore
• Contact: Cynthia Chen, PhD
• Phone: 66015526
• Email: cynchen[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the randomized controlled trials is to learn about the effects of urban farming interventions on older adults' physical, mental, and social well-being of older adults aged 50 and above. The main questions the study aims to answer are Q1. Would participants who have undergone the urban care farming intervention have lower stress levels compared to those who did not undergo the intervention? Q2. Would the quality of life and biopsychosocial factors of older adults who participate in the urban farming interventions be better before the intervention and compared to those who did not participate? Q3. Would running intervention programs as such demonstrate cost-effectiveness? Participants will be enrolled in 24 weekly lessons providing hands-on urban farming techniques, including physical activity, planting, and social interactions. Researchers will compare older participants with similar demographic profile to determine if the biological, psychological, and social factors are better for the intervention group.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Behavioral:
• Urban care farming
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.

Locations

Country	Name	City	State
Singapore	Jurong Lake Garden	Singapore
Singapore	NUS	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University of Singapore	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WHO Quality of Life Scale (WHOQOL-BREF)	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	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	changes in concentration of cytokines, chemokines and selected ageing and inflammatory markers in measured in pg/mL	Baseline, 6 months
Secondary	Brief sense of community scale (BSCS)	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
Secondary	Fried phenotype of frailty	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
Secondary	Lubben social network scale (LSNS-6)	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
Secondary	Functional near-infrared spectroscopy	Brain oxygenation levels measured in cerebral metabolic rate of oxygen (CMRO^2).	Baseline, 6 months
Secondary	EQ5D	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
Secondary	Geriatric anxiety scale (GAS-10)	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
Secondary	MOCA	Participants are scored following MOCA scoring criteria. Max. 30 points. Scores lower than 26 showed signs of cognitive impairment.	Baseline, 6 months, 12 months
Secondary	Brief resilience scale	Resilience scale on a 5 points scale, strongly disagree to strongly agree, the higher the score, the greater resilience.	Baseline, 6 months, 12 months
Secondary	De jong Gierveld loneliness scale	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
Secondary	Fitbit	Steps count	Continuous for 12 months
Secondary	Body weight and height	Measured in kilograms and metres respectively. Weight and height will be combined to report BMI in kg/m^2	Baseline, 6 months, 12 months
Secondary	Fasting plasma glucose, HbA1c	measures average blood sugar levels over the past 3 months	Baseline, 6 months
Secondary	Serum Creatinine	measures the level of creatinine in the blood	Baseline, 6 months
Secondary	Attitude towards eating healthy food	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
Secondary	Waist and hip circumference	Measured in centimetres	Baseline, 6 months, 12 months
Secondary	Blood pressure	Measured in systolic and diastolic	Baseline, 6 months, 12 months
Secondary	Lipid panel	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
Secondary	Eating fruits and vegetables behavior	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