ChiCTR2100051568 版本V1.0 版本创建时间2021/09/27 04:27:18 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2100051568 

最近更新日期：

Date of Last Refreshed on：

2021-09-27 04:26:42 

注册时间：

Date of Registration：

2021-09-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Cardiac and mental benefits of Mediterranean-DASH intervention for Neurodegenerative delay (MIND) diet plus Forest Bathing (FB) versus MIND diet among Chinese older adults: A Pilot study

Public title：

Cardiac and mental benefits of Mediterranean-DASH intervention for Neurodegenerative delay (MIND) diet plus Forest Bathing (FB) versus MIND diet among Chinese older adults: A Pilot study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Cardiac and mental benefits of Mediterranean-DASH intervention for Neurodegenerative delay (MIND) diet plus Forest Bathing (FB) versus MIND diet among Chinese older adults: A Pilot study

Scientific title：

Cardiac and mental benefits of Mediterranean-DASH intervention for Neurodegenerative delay (MIND) diet plus Forest Bathing (FB) versus MIND diet among Chinese older adults: A Pilot study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Yau Ka Yin Katherine 

研究负责人：

Yau Ka Yin Katherine 

Applicant：

Yau Ka Yin Katherine  

Study leader：

Yau Ka Yin Katherine  

申请注册联系人电话：

Applicant telephone：

+852-3190 6689

研究负责人电话：

Study leader's telephone：

+852-3190 6689

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

kyyau@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

kyyau@twc.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

香港葵涌葵昌路51號 九龍貿易中心第2座16樓

研究负责人通讯地址：

香港葵涌葵昌路51號 九龍貿易中心第2座16樓

Applicant address：

Tung Wah College Limited, 16/F, Tower 2, Kowloon Commerce Centre, 51 Kwai Cheong Road, Kwai Chung, Hong Kong, China

Study leader's address：

Tung Wah College Limited, 16/F, Tower 2, Kowloon Commerce Centre, 51 Kwai Cheong Road, Kwai Chung, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港東華學院護理學院

Applicant's institution：

School of Nursing, Tung Wah College

研究负责人所在单位：

香港東華學院護理學院

Affiliation of the Leader：

School of Nursing, Tung Wah College

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

N/A

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Tung Wah College, Research Committee

Name of the ethic committee：

Tung Wah College, Research Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2013-08-26 00:00:00

伦理委员会联系人：

Tung Wah College, Research Committee

Contact Name of the ethic committee：

Tung Wah College, Research Committee

伦理委员会联系地址：

中國香港特別行政區旺角山東街 90號A鍾江海紀念大樓及98號鍾秦蘭鳳大樓4樓

Contact Address of the ethic committee：

4/F, Nos. 90A & 98, Shantung Street, Mongkok, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Tung Wah College

Primary sponsor：

Tung Wah College

研究实施负责（组长）单位地址：

中國香港特別行政區葵涌葵昌路51號九龍貿易中心第2座16樓

Primary sponsor's address：

Tung Wah College Limited, 16/F, Tower 2, Kowloon Commerce Centre, 51 Kwai Cheong Road, Kwai Chung, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

College research grant

Source(s) of funding：

College research grant

Target disease：

Hypertension

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To examine and compare the effects of a 12-week period of MIND diet plus FB, MIND diet only and control group on systolic BP, lipid profile and glucose, waist-to-hip ratio, body fat percentages, body mass index, state and trait anxiety level, and mood states of participants on week 4, 8 and 12 of intervention.  

Objectives of Study：

To examine and compare the effects of a 12-week period of MIND diet plus FB, MIND diet only and control group on systolic BP, lipid profile and glucose, waist-to-hip ratio, body fat percentages, body mass index, state and trait anxiety level, and mood states of participants on week 4, 8 and 12 of intervention.

药物成份或治疗方案详述：

MIND diet Intervention: The MIND diet intervention used for this study is based on the MIND diet developed by Morris and colleagues in 2015 [40]. Participants will be required to consume MIND diet for 12 weeks. MIND diet promotes 10 healthy foods and limits 5 unhealthy food groups. A 7-day sample menu is developed, meeting the required number of servings per day every week, as reference. This 7-day sample is designed to fit the principles of MIND diet with local and culturally suitable food choices for participants as reference. Participants will be received a 4-week nutrition programme consisting of 4 sessions (one session per week, 60 min per session) in the activity room of participating community centre or in the classroom of Tung Wah College. In the nutrition sessions, participants will learn to modify their diet to meet MIND diet guidelines. Each intervention session will be conducted by a nutritionist with the help of a research assistant to maintain consistency. The nutritionist-to-participant ratio for each session will be 1:15. Topics covered during the programme including how to promote overview of MIND diet; discussion of establishing rapport with participants and instruction regarding BP measurement, dietary adoption and adherence checks using logbook to enable informed decision making and adherence to nutritional recommendations. The strategies for promoting the readiness of changes in the nutrition session including exploring the participants capability (cooking skills and knowledge), opportunity (time, home/work environment, healthy work lunch, access to quality food/ seasonal foods and family support) and motivation (taste preference, convenience, culture, improved health, memory, planning and organisation) on adoption MIND diet. To increase adoption and adherence to MIND diet, we will provide HK$50 supermarket coupon per month after each measurement (during first three months only, with purchasing receipts to reflect consistent with MIND diet e.g., berries, wholegrains, beans). MIND-plus-FB intervention: The MIND-plus-FB intervention will last for 12 weeks, consisting of 8 sessions (two sessions per the first four week). The MIND diet will follow the steps mentioned in the previous section. MIND diet intervention will be one session per week, 60 min per session, in the activity room of each participating community centre. FB will be another session per week, 2 hours forest bathing sessions on 4-consecutive weekends in a country park at daytime with sunny, cloudy, or drizzling conditions. The walking distance for each forest bathing is one to two kilometres. The session will be rescheduled to the next weekend if there is heavy rainy day. The best temperatures for forest bathing session are ranging from 11 to 25 °C. In view of humidity and temperatures in HK, FB is suitable to be conducted between January to June, and September to December respectively. On the day of FB, participants will gather at the entrance of the country park for briefing and measuring physical parameters e.g., BP and pluses to ensure physical fitness. FB coach will begin the FB intervention by a set of experiential thresholds, called Standard Sequence [34] to facilitate participants deeper connection to the nature via sensory activity along the path. Each intervention session will follow an identical invitation: (i) sharing experience for the forest (20 minutes) (ii) centre yourself at the pleasure of moment using five senses (20 minutes), (iii) wander down the designed forest path to slow down both physically and mentally (20 minutes) and (iv) build up a deeper connection to forest by alertness what happen of the surrounding (20 minutes). Participants will be given around 20 minutes of rest and sharing time between each activity change. The tea Ceremony, as second threshold, is incorporated at the end of each session. All intervention sessions will be conducted by a certified FB coach with wilderness first aid certificate by the Association of Nature & Forest therapy (ANFT). The FB coach will ensure safety during FB. The coach-to-participant ratio is approximately 1:15. A research assistance and a helper (both holding a first aid license) will also be hired to correct data and maintain the consistency in each session. Participants will then be required to self-practice 2h FB in the country park at daytime at the weekends of 8th week and 12th week of the intervention. During the 4-session face-to-face FB, certified coach will convey the safety issues and concern about self-initiated FB to participants (Appendix 1). Control group A control group with usual care will be added to illuminate the effect of MIND and MIND-plus-FB. Follow-up of interventions: Participants will be instructed to perform usual lifestyle activities during the intervention periods. A logbook will be given to the participants to record their compliance with the interventions, including the BP measurement, dietary adoption, frequency of FB and adherence checks. Telephone calls will be made every 2 weeks after the 4-week intervention, during which the participants can raise any questions on practicing MIND diet and FB and consolidating their progress and learning. If the participants are unable to adhere to the MIND diet and FB, the trained research assistant will discuss with them the barriers/challenges faced and give immediate feedback.  

Description for medicine or protocol of treatment in detail：

MIND diet Intervention: The MIND diet intervention used for this study is based on the MIND diet developed by Morris and colleagues in 2015 [40]. Participants will be required to consume MIND diet for 12 weeks. MIND diet promotes 10 healthy foods and limits 5 unhealthy food groups. A 7-day sample menu is developed, meeting the required number of servings per day every week, as reference. This 7-day sample is designed to fit the principles of MIND diet with local and culturally suitable food choices for participants as reference. Participants will be received a 4-week nutrition programme consisting of 4 sessions (one session per week, 60 min per session) in the activity room of participating community centre or in the classroom of Tung Wah College. In the nutrition sessions, participants will learn to modify their diet to meet MIND diet guidelines. Each intervention session will be conducted by a nutritionist with the help of a research assistant to maintain consistency. The nutritionist-to-participant ratio for each session will be 1:15. Topics covered during the programme including how to promote overview of MIND diet; discussion of establishing rapport with participants and instruction regarding BP measurement, dietary adoption and adherence checks using logbook to enable informed decision making and adherence to nutritional recommendations. The strategies for promoting the readiness of changes in the nutrition session including exploring the participants capability (cooking skills and knowledge), opportunity (time, home/work environment, healthy work lunch, access to quality food/ seasonal foods and family support) and motivation (taste preference, convenience, culture, improved health, memory, planning and organisation) on adoption MIND diet. To increase adoption and adherence to MIND diet, we will provide HK$50 supermarket coupon per month after each measurement (during first three months only, with purchasing receipts to reflect consistent with MIND diet e.g., berries, wholegrains, beans). MIND-plus-FB intervention: The MIND-plus-FB intervention will last for 12 weeks, consisting of 8 sessions (two sessions per the first four week). The MIND diet will follow the steps mentioned in the previous section. MIND diet intervention will be one session per week, 60 min per session, in the activity room of each participating community centre. FB will be another session per week, 2 hours forest bathing sessions on 4-consecutive weekends in a country park at daytime with sunny, cloudy, or drizzling conditions. The walking distance for each forest bathing is one to two kilometres. The session will be rescheduled to the next weekend if there is heavy rainy day. The best temperatures for forest bathing session are ranging from 11 to 25 °C. In view of humidity and temperatures in HK, FB is suitable to be conducted between January to June, and September to December respectively. On the day of FB, participants will gather at the entrance of the country park for briefing and measuring physical parameters e.g., BP and pluses to ensure physical fitness. FB coach will begin the FB intervention by a set of experiential thresholds, called Standard Sequence [34] to facilitate participants deeper connection to the nature via sensory activity along the path. Each intervention session will follow an identical invitation: (i) sharing experience for the forest (20 minutes) (ii) centre yourself at the pleasure of moment using five senses (20 minutes), (iii) wander down the designed forest path to slow down both physically and mentally (20 minutes) and (iv) build up a deeper connection to forest by alertness what happen of the surrounding (20 minutes). Participants will be given around 20 minutes of rest and sharing time between each activity change. The tea Ceremony, as second threshold, is incorporated at the end of each session. All intervention sessions will be conducted by a certified FB coach with wilderness first aid certificate by the Association of Nature & Forest therapy (ANFT). The FB coach will ensure safety during FB. The coach-to-participant ratio is approximately 1:15. A research assistance and a helper (both holding a first aid license) will also be hired to correct data and maintain the consistency in each session. Participants will then be required to self-practice 2h FB in the country park at daytime at the weekends of 8th week and 12th week of the intervention. During the 4-session face-to-face FB, certified coach will convey the safety issues and concern about self-initiated FB to participants (Appendix 1). Control group A control group with usual care will be added to illuminate the effect of MIND and MIND-plus-FB. Follow-up of interventions: Participants will be instructed to perform usual lifestyle activities during the intervention periods. A logbook will be given to the participants to record their compliance with the interventions, including the BP measurement, dietary adoption, frequency of FB and adherence checks. Telephone calls will be made every 2 weeks after the 4-week intervention, during which the participants can raise any questions on practicing MIND diet and FB and consolidating their progress and learning. If the participants are unable to adhere to the MIND diet and FB, the trained research assistant will discuss with them the barriers/challenges faced and give immediate feedback.  

纳入标准：

The inclusion criteria of this proposed study are:
(1) aged over 50 years;
(2) Chinese ethnicity;
(3) ability to speak and understand Chinese;
(4) fulfilment of the AHA criteria for stage 1 (SBP 130-139 mmHg or DBP 80-89 mmHg) and stage 2 hypertension (SBP >=140 mmHg or DBP >=90 mmHg);
(5) physical fitness to take part in mild-intensity exercises.

Inclusion criteria

The inclusion criteria of this proposed study are:
(1) aged over 50 years;
(2) Chinese ethnicity;
(3) ability to speak and understand Chinese;
(4) fulfilment of the AHA criteria for stage 1 (SBP 130-139 mmHg or DBP 80-89 mmHg) and stage 2 hypertension (SBP >=140 mmHg or DBP >=90 mmHg);
(5) physical fitness to take part in mild-intensity exercises.

排除标准：

(1) poorly controlled chronic disease, including chronic obstructive pulmonary disease, cardiovascular disease, kidney disease and diabetes;
(2) allergy to more than one type of food (nuts, berries, olive oil, or fish);
(3) use of medications to treat known mental disorder;
(4) pregnant;
(5) those who are currently participating in any dietary or relaxation programme or those who had participated in any dietary or relaxation programme for the past 3 months;
(6) those experienced chronic pain and muscle weakness;
(7) those were unable to walk independently;
(8) those with extremely high SBP >159 mmHg and/or DBP >100 mmHg, were excluded.

Exclusion criteria：

(1) poorly controlled chronic disease, including chronic obstructive pulmonary disease, cardiovascular disease, kidney disease and diabetes;
(2) allergy to more than one type of food (nuts, berries, olive oil, or fish);
(3) use of medications to treat known mental disorder;
(4) pregnant;
(5) those who are currently participating in any dietary or relaxation programme or those who had participated in any dietary or relaxation programme for the past 3 months;
(6) those experienced chronic pain and muscle weakness;
(7) those were unable to walk independently;
(8) those with extremely high SBP >159 mmHg and/or DBP >100 mmHg, were excluded.

研究实施时间：

Study execute time：

从 From 2021-11-08 00:00:00至 To 2022-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-10-04 00:00:00 至 To 2021-11-07 00:00:00  

干预措施：

Interventions：

组别：

Intervention group 1

样本量：

26

Group：

Intervention group 1

Sample size：

干预措施：

Mind diet plus forest bathing

干预措施代码：

Intervention：

Mind diet plus forest bathing

Intervention code：

组别：

Intervention group 2

样本量：

26

Group：

Intervention group 2

Sample size：

干预措施：

Mind diet only

干预措施代码：

Intervention：

Mind diet only

Intervention code：

组别：

control group

样本量：

26

Group：

control group

Sample size：

干预措施：

usual care

干预措施代码：

Intervention：

usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

community 

单位级别：

primary 

Institution
hospital：

community

Level of the institution：

primary

测量指标：

Outcomes：

指标中文名：

SBP

指标类型：

主要指标

Outcome：

SBP

Type：

Primary indicator

测量时间点：

4

测量方法：

digital automatic device

Measure time point of outcome：

4

Measure method：

digital automatic device

指标中文名：

Lipid panel (HDL-cholesterol, triglycerides, and LDL-cholesterol) and glucose

指标类型：

次要指标

Outcome：

Lipid panel (HDL-cholesterol, triglycerides, and LDL-cholesterol) and glucose

Type：

Secondary indicator

测量时间点：

4

测量方法：

Point of care test (POCT)

Measure time point of outcome：

4

Measure method：

Point of care test (POCT)

指标中文名：

waist-to-hip ratio

指标类型：

次要指标

Outcome：

waist-to-hip ratio

Type：

Secondary indicator

测量时间点：

4

测量方法：

waist circumference (cm) divided by hip circumference (cm) divided by hip circumference (cm).

Measure time point of outcome：

4

Measure method：

waist circumference (cm) divided by hip circumference (cm) divided by hip circumference (cm).

指标中文名：

Body fat percentages and BMI

指标类型：

次要指标

Outcome：

Body fat percentages and BMI

Type：

Secondary indicator

测量时间点：

4

测量方法：

bioelectrical impedance analysis (BIA)

Measure time point of outcome：

4

Measure method：

bioelectrical impedance analysis (BIA)

指标中文名：

mood states

指标类型：

次要指标

Outcome：

mood states

Type：

Secondary indicator

测量时间点：

4

测量方法：

The Profile of Mood States Short Form (POMS-SF)

Measure time point of outcome：

4

Measure method：

The Profile of Mood States Short Form (POMS-SF)

指标中文名：

Anxiety level

指标类型：

次要指标

Outcome：

Anxiety level

Type：

Secondary indicator

测量时间点：

4

测量方法：

State and Trait Anxiety Inventory (STAI)

Measure time point of outcome：

4

Measure method：

State and Trait Anxiety Inventory (STAI)

指标中文名：

Waist circumference

指标类型：

次要指标

Outcome：

Waist circumference

Type：

Secondary indicator

测量时间点：

4

测量方法：

between the lower rib and iliac crest by tape meter.

Measure time point of outcome：

4

Measure method：

between the lower rib and iliac crest by tape meter.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Blood

组织：

Sample Name：

capillary blood sample

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 70 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

The applicants will generates the random number by a true random number generator.

Randomization Procedure (please state who generates the random number sequence and by what method)：

The applicants will generates the random number by a true random number generator.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Single blind

Blinding：

It will be a single-blind trial; only the assessors will be blinded to the treatment assignment.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

https://www.chictr.org.cn/

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

https://www.chictr.org.cn/

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Case record form and an electronic data capture will be used for data collection and record.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case record form and an electronic data capture will be used for data collection and record.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-09-27 04:26:42