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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06277583
Other study ID # NUS-IRB-2023-191
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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