About this trial
Depression is a common mental health issue in older adults, often manifesting as insomnia, low mood, vague somatic complaints, cognitive decline, and recurrent thoughts of death or suicide. Even subthreshold depressive symptoms in late life significantly impair quality of life. In Hong Kong, recent data show high prevalence of depressive symptoms among community-dwelling older adults (43.7% in men, 54.8% in women), underscoring the urgent public health and economic need for effective interventions.
Although the previous evidence has shown that BDJ and GT consumption can improve depressive symptoms, gut microbiota, and QoL respectively, the feasibility and effect of the combination of two intervention approaches in older adults remain unclear. Therefore, the proposed study aims to (1) determine the feasibility of a 12-week blended BDJ and GT consumption program among Hong Kong community-dwelling older adults with depressive symptoms in a small-scale sample, and (2) examine the effects of the blended BDJ and GT consumption program on their depressive symptoms, gut-microbiota and QoL compared with that in the active control group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
community-dwelling older adults aged 65 to 84 years, who are youngest-old and middle-old with relatively stable health status compared with oldest-old aged 85 years and above
Scoring 5-15 using the Chinese version of Geriatric Depression Scale.
Access the smartphone and internet through which the Hospital Authority (HA) HA Go mobile app.
Pass the PAR-Q screening and no contraindications for physical exercise.
Disqualifiers
suffer from cognitive impairment identified by the Chinese version of the Mini-Mental Status Examination (i.e., score < 24).
regularly consume tea or coffee (≥3 times/day, last for ≥6 months) as these habitual behaviors can contaminate the effects of tea consumption intervention per se.
Individuals with contraindications for tea consumption, such as insomnia, anemia, neurasthenia, hyperthyroidism, digestive ulcers, etc.
The concurrent use of sedative and tranquilizer medications, such as benzodiazepines and barbiturates.
Trial design
Parallel
Treatments tested in this trial
blended Baduanjin and Green Tea consumption program
BehavioralThe participants will be invited to attend both BDJ exercise and GT consumption interventions for 12 weeks. The exercise instructor will provide group teaching with individual instructions on specific movements. Participants will also adopt a dose of 3g tea with 200ml water, 2 cups daily. The tea consumption will last 12 weeks in this project to keep the same intervention duration as BDJ group.
Non-treatment control
BehavioralParticipants will receive biweekly telephone calls within 12 weeks.Each call will last about 5 minutes.The participants will be asked several questions about their physical exercise and tea consumption behaviors.
Treatment groups
Trial outcomes
Primary outcomes
Self-reported depressive symptoms
The Chinese version of the 15-item Geriatric Depression Scale (GDS-C) will be used to measure the subjective depression level. The GDS are the most widely used scales for the detection of depression symptoms in older adults (Cronbach's α = .81 -.83).
Secondary outcomes
Gut-microbiota
Total genomic DNA will be extracted from stool samples using NEBnext microbiome DNA enrichment kit (New England Biolabs, Ipswich, MA, US) following the manufacturer's instructions. Gut microbiome will be an be analysed by 16S rRNA gene amplicon sequencing for the V3-V4 region (OmicLab Limited, Hong Kong). The amplified products will be sequenced on the Illumina NovaSeq platform and analysed using QIIME1 software. Several microbiome compositional and functional indicators will be measured, e.g., total gene counts, relative abundance of predominant bacterial groups, alpha and beta diversity, and functional annotations of the gut microbiota (Hu et al., 2023; Wang et al., 2023). DNA extraction, 16S rRNA sequencing and analyses will be performed by OmicLab Limited, Hong Kong.
Perceived quality of life
The quality of life will be assessed using the brief version of the Hong Kong Chinese WHO Quality of Life Scale (WHOQOL-BREF) (Cronbach's α = .73 - .84). The scale includes 28 items, covering four dimensions of how older adults perceive their quality of life. The total score of the questionnaire ranges from 28 to 140, and a higher score indicates that the individual feels they have a high quality of life.
Other outcomes
Retention rate
Percentage of participants completing assessments at the pre-intervention test, post-intervention test, and follow-up test. Criterion: at least 75% of participants completed data collection.
Session attendance rate
Participants completed at least 83% of intervention sessions for BDJ (20 out of 24 sessions) and GT consumption (140 out of 168 cups)
Sponsors and contacts
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