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The effect of a theory-based educational program on nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity in Hong Kong community settings
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注册号：

Registration number：

 ChiCTR2400079401 

最近更新日期：

Date of Last Refreshed on：

 2024-01-02 16:58:39 

注册时间：

Date of Registration：

 2024-01-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effect of a theory-based educational program on nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity in Hong Kong community settings

Public title：

The effect of a theory-based educational program on nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity in Hong Kong community settings

注册题目简写：

None

English Acronym：

None

研究课题的正式科学名称：

The effect of a theory-based educational program on nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity in Hong Kong community settings

Scientific title：

The effect of a theory-based educational program on nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity in Hong Kong community settings

研究课题代号(代码)：

Study subject ID：

 None

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：

None

申请注册联系人：

Lui Lai Shan 

研究负责人：

Lui Lai Shan 

Applicant：

Lui Lai Shan 

Study leader：

Lui Lai Shan 

申请注册联系人电话：

Applicant telephone：

 +852 9150 1750

研究负责人电话：

Study leader's
telephone：

+852 9150 1750

申请注册联系人传真 ：

Applicant Fax：

 None

研究负责人传真：

Study leader's fax：

 none

申请注册联系人电子邮件：

Applicant E-mail：

 1155042692@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1155042692@link.cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 None

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 None

申请注册联系人通讯地址：

Flat D, Floor 22, Tower 12, Ocean Shores, 88 O King Road, Tseung Kwan O, Hong Kong

研究负责人通讯地址：

Flat D, Floor 22, Tower 12, Ocean Shores, 88 O King Road, Tseung Kwan O, Hong Kong

Applicant address：

Flat D, Floor 22, Tower 12, Ocean Shores, 88 O King Road, Tseung Kwan O, Hong Kong

Study leader's address：

Flat D, Floor 22, Tower 12, Ocean Shores, 88 O King Road, Tseung Kwan O, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

 None

研究负责人邮政编码：

Study leader's postcode：

 None

申请人所在单位：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2023.558-T

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-12-18 00:00:00

伦理委员会联系人：

Matthew Cheung

Contact Name of the ethic committee：

Matthew Cheung

伦理委员会联系地址：

8/F, Lui Chi Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Chi Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Chinese University of Hong Kong: Horse Material Water, Shatin, New Territories, Hong Kong

Primary sponsor's address：

The Chinese University of Hong Kong: Horse Material Water, Shatin, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hongkong

市(区县)：

None

Country：

China

Province：

Hongkong

City：

None

单位(医院)：

Kowloon City Baptist Social Service

具体地址：

903, 9/F, Yee Kuk Industrial Ctr, 555 Yee Kuk St., Cheung Sha, Wan, Kowloon

Institution
hospital：

Kowloon City Baptist Social Service

Address：

903, 9/F, Yee Kuk Industrial Ctr, 555 Yee Kuk St., Cheung Sha, Wan, Kowloon

经费或物资来源：

Self finance

Source(s) of funding：

Self finance

研究疾病：

Obesity  

Target disease：

Obesity

研究疾病代码：

None

Target disease code：

None

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

This study aims to improve nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity through a theory-based education program.  

Objectives of Study：

This study aims to improve nutritional knowledge, health-related behavior, and health outcomes in individuals with obesity through a theory-based education program.

药物成份或治疗方案详述：

None 

Description for medicine or protocol of treatment in detail：

None 

纳入标准：

Inclusion criteria

排除标准：

Exclusive criteria include medical conditions restricting physical activity, psychiatric illnesses, or engagement in a weight loss program.

Exclusion criteria：

Exclusive criteria include medical conditions restricting physical activity, psychiatric illnesses, or engagement in a weight loss program.

研究实施时间：

Study execute time：

从 From 2024-01-06 00:00:00至 To 2024-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-06 00:00:00 至 To 2024-06-16 00:00:00

干预措施：

Interventions：

组别：

Intervention

样本量：

 89

Group：

Intervention

Sample size：

干预措施：

Based on the health belief model, the program aims to improve knowledge about nutrition, health-related behaviors, and health outcomes. It will span four community centers in different districts and involve clustered randomized control trials. Over the course of 12 weeks, participants will receive guidance and support from a team of multi-disciplinary professionals - nurses, physiotherapists, and dietitians in both group settings and individual consultations. To enhance adherence and self-efficacy, an online video chat, two follow-up calls, and an asynchronous online conversation will be available. Section one (Group discussion in week one): The activity consists of three parts. Groups health education sessions on obesity-related knowledge, diet, and exercise management, with demonstrations of home-based exercise examples. Part one: Nurses organize a group education session to improve participants’ understanding of obesity-related risks and consequences. The session discussed the causes of obesity, various health issues, societal impacts, the global prevalence of the obesity problem, and discusses preventive measures and encourages participants to identify their perceived susceptibility to obesity and utilize evidence-based information to discuss the risk factors, such as genetic predisposition, environmental and social factors, as well as the statistics of associated diseases. Part Two: Dietitians will provide “Cue” and emphasizing the perceived benefits of adopting a positive change of healthy lifestyle and maintaining a normal body mass index. Enhance nutritional knowledge, such as consuming high dietary fiber, reducing intake of saturated fats, cholesterol, and sugars, and how to read food labels to make healthier food choices. Provide skills for grocery shopping, food preparation, cooking, and storage techniques. In addition, identify the perceived barriers and suggest strategies to overcome and suggest strategies for healthy food choices in convenient shop and dining out Part three: Physiotherapists will suggest the perceived benefit of exercise to achieve a normal body mass index and to improve physical health. They will recommend at least 150 minutes of moderate-to-vigorous physical activity throughout the week. Educate on exercise management, which includes information on different types of exercise, their perceived benefits, recommendations on exercise regimens, and address safety concern, such as maintaining a heart rate of 50-70% of the maximum, and the precaution for exercise training. Discuss the perceived barriers for exercise management and recommend strategies overcome them. And demonstrate and allow for return demonstrations of home-based exercises. These exercises may include aerobic, stretching, or resistance exercises. Section Two (individual health consultation in week two) Each participant in the program has the opportunity to consult with a healthcare professional individually with nurses, dietitians, and physiotherapists individually. The assessment is based on current demographic date and anthropometric parameters, such as body mass index to assess their weight status, Framingham risk score, blood pressure measurement and total cholesterol level to evaluate an individual’ cardiovascular risk. A higher score on the assessment indicates a greater perceived severity of cardiovascular risks. A preliminary high glucose result may indicate the perceived susceptibility of suffering from diabetes. Section three ((Online synchronous video call in week Five) The nurse and the physiotherapist will focus on improving participants’ nutritional knowledge and promoting healthy behaviors by using both internal and external signals to prompt action’, They will provide expert guidelines, demonstrate correct exercise techniques, and preventive measures, address any barriers or challenges that participants may face in real-time, and offer immediate solutions and alternatives. The program also aims to provide psychological support to address any potential barriers when adopting behavior changes. To encourage healthier lifestyle choices, a supportive environment will be created, where participants can take prompt “Cue to action”. Section Four (Two telephone follow ups in week 9 and week 11) The nurse conducts two phone follow-ups for goal reinforcement, monitoring progress and rectification of predetermined goals. Answer nutrition health-related questions and provide verbal support to enhance self-efficacy. Section Five (An online asynchronous discussion using WhatsApp message from Week One to Week Twelve) Monitor by the nurse, an asynchronous online discussion using WhatsApp messaging platform take place from the first and twelfth week. Use personalized message to enhance perceived susceptibility, such as to the related risks for individuals who are overweight and obese. Also, encourage participants to share information about the health implications of obesity and discuss the health implications of obesity. It can raise perception and promote a better understanding of the severity of this issue. To promote “Cue of action”, it is important to provide regular reminders and updates on public health campaigns for obesity prevention. Sharing success stories can motivate group members to perceive the benefits of reducing body weight, while discussing challenges and offering solutions can create a supportive environment to overcome barriers encountered during lifestyle modifications. Celebrating achievements can help to build self-efficacy in diet and exercise management

干预措施代码：

 None

Intervention：

Based on the health belief model, the program aims to improve knowledge about nutrition, health-related behaviors, and health outcomes. It will span four community centers in different districts and involve clustered randomized control trials. Over the course of 12 weeks, participants will receive guidance and support from a team of multi-disciplinary professionals - nurses, physiotherapists, and dietitians in both group settings and individual consultations. To enhance adherence and self-efficacy, an online video chat, two follow-up calls, and an asynchronous online conversation will be available. Section one (Group discussion in week one): The activity consists of three parts. Groups health education sessions on obesity-related knowledge, diet, and exercise management, with demonstrations of home-based exercise examples. Part one: Nurses organize a group education session to improve participants’ understanding of obesity-related risks and consequences. The session discussed the causes of obesity, various health issues, societal impacts, the global prevalence of the obesity problem, and discusses preventive measures and encourages participants to identify their perceived susceptibility to obesity and utilize evidence-based information to discuss the risk factors, such as genetic predisposition, environmental and social factors, as well as the statistics of associated diseases. Part Two: Dietitians will provide "Cue" and emphasizing the perceived benefits of adopting a positive change of healthy lifestyle and maintaining a normal body mass index. Enhance nutritional knowledge, such as consuming high dietary fiber, reducing intake of saturated fats, cholesterol, and sugars, and how to read food labels to make healthier food choices. Provide skills for grocery shopping, food preparation, cooking, and storage techniques. In addition, identify the perceived barriers and suggest strategies to overcome and suggest strategies for healthy food choices in convenient shop and dining out Part three: Physiotherapists will suggest the perceived benefit of exercise to achieve a normal body mass index and to improve physical health. They will recommend at least 150 minutes of moderate-to-vigorous physical activity throughout the week. Educate on exercise management, which includes information on different types of exercise, their perceived benefits, recommendations on exercise regimens, and address safety concern, such as maintaining a heart rate of 50-70% of the maximum, and the precaution for exercise training. Discuss the perceived barriers for exercise management and recommend strategies overcome them. And demonstrate and allow for return demonstrations of home-based exercises. These exercises may include aerobic, stretching, or resistance exercises. Section Two (individual health consultation in week two) Each participant in the program has the opportunity to consult with a healthcare professional individually with nurses, dietitians, and physiotherapists individually. The assessment is based on current demographic date and anthropometric parameters, such as body mass index to assess their weight status, Framingham risk score, blood pressure measurement and total cholesterol level to evaluate an individual’ cardiovascular risk. A higher score on the assessment indicates a greater perceived severity of cardiovascular risks. A preliminary high glucose result may indicate the perceived susceptibility of suffering from diabetes. Section three ((Online synchronous video call in week Five) The nurse and the physiotherapist will focus on improving participants’ nutritional knowledge and promoting healthy behaviors by using both internal and external signals to prompt action’, They will provide expert guidelines, demonstrate correct exercise techniques, and preventive measures, address any barriers or challenges that participants may face in real-time, and offer immediate solutions and alternatives. The program also aims to provide psychological support to address any potential barriers when adopting behavior changes. To encourage healthier lifestyle choices, a supportive environment will be created, where participants can take prompt "Cue to action". Section Four (Two telephone follow ups in week 9 and week 11) The nurse conducts two phone follow-ups for goal reinforcement, monitoring progress and rectification of predetermined goals. Answer nutrition health-related questions and provide verbal support to enhance self-efficacy. Section Five (An online asynchronous discussion using WhatsApp message from Week One to Week Twelve) Monitor by the nurse, an asynchronous online discussion using WhatsApp messaging platform take place from the first and twelfth week. Use personalized message to enhance perceived susceptibility, such as to the related risks for individuals who are overweight and obese. Also, encourage participants to share information about the health implications of obesity and discuss the health implications of obesity. It can raise perception and promote a better understanding of the severity of this issue. To promote "Cue of action", it is important to provide regular reminders and updates on public health campaigns for obesity prevention. Sharing success stories can motivate group members to perceive the benefits of reducing body weight, while discussing challenges and offering solutions can create a supportive environment to overcome barriers encountered during lifestyle modifications. Celebrating achievements can help to build self-efficacy in diet and exercise management

Intervention code：

组别：

Control group

样本量：

 89

Group：

Control group

Sample size：

干预措施：

In the first week, group intervention will be provided with 30 minutes of education on preventing obesity and receiving dietary advice through health brochures from the government on obesity prevention and dietary advice. Additionally, to avoid attention bias, participants received two reminders during weeks nine and eleven about the previously distributed pamphlet.

干预措施代码：

 None

Intervention：

In the first week, group intervention will be provided with 30 minutes of education on preventing obesity and receiving dietary advice through health brochures from the government on obesity prevention and dietary advice. Additionally, to avoid attention bias, participants received two reminders during weeks nine and eleven about the previously distributed pamphlet.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 None 

市(区县)：

 None 

Country：

Hong Kong

Province：

None

City：

None

单位(医院)：

 In community center 

单位级别：

 None 

Institution
hospital：

In community center

Level of the institution：

None

测量指标：

Outcomes：

指标中文名：

To assess nutritional knowledge

指标类型：

主要指标

Outcome：

To assess nutritional knowledge

Type：

Primary indicator

测量时间点：

Pre and post 12 weeks

测量方法：

Questionnaire

Measure time point of outcome：

Pre and post 12 weeks

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

25uL blood (one drop from fingertip)

组织：

none

Sample Name：

25uL blood (one drop from fingertip)

Tissue：

None

人体标本去向

 使用后销毁  

说明

none

Fate of sample：

Destruction after use  

Note：

none

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 44 岁 years
最大 Max age 60 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）：

A simple randomized method should be used to assign each center to a group entirely by chance (A total of 4 centers). This can be achieved through a random number generator, with opaque-sealed envelopes used in a 1:1 ratio. For example, centers assigned an odd number will be in the intervention group, while those assigned an even number will be in the control group.

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

A simple randomized method should be used to assign each center to a group entirely by chance (A total of 4 centers). This can be achieved through a random number generator, with opaque-sealed envelopes used in a 1:1 ratio. For example, centers assigned an odd number will be in the intervention group, while those assigned an even number will be in the control group.

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：

Before collecting baseline data, written consent will be obtained from all participants. The study will be conducted as a single-blind design, with the research assistant responsible for collecting primary outcome measures being blinded to group assignment.

Blinding：

Before collecting baseline data, written consent will be obtained from all participants. The study will be conducted as a single-blind design, with the research assistant responsible for collecting primary outcome measures being blinded to group 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

是Yes

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）：

Not yet

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

Not yet

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：

This study will strictly follow the Declaration of Helsinki's ethical principles. The Joint CUHK-NTEC Ethics Committee will be approached for ethical approval. Participants will be informed about the study's purpose, procedures, potential benefits, and risks. They will also be assured of their right to decline participation and/or withdraw from the study at any time without any consequences. Personal information and data will be anonymized, kept confidential, and securely stored on a password-protected computer. All data will be kept in a locked cabinet for seven years and subsequently destroyed. Paper records will be shredded, while records stored on the computer's hard drive will be erased using commercial software to remove all data from the storage device. We will use a case record form to record.

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

This study will strictly follow the Declaration of Helsinki's ethical principles. The Joint CUHK-NTEC Ethics Committee will be approached for ethical approval. Participants will be informed about the study's purpose, procedures, potential benefits, and risks. They will also be assured of their right to decline participation and/or withdraw from the study at any time without any consequences. Personal information and data will be anonymized, kept confidential, and securely stored on a password-protected computer. All data will be kept in a locked cabinet for seven years and subsequently destroyed. Paper records will be shredded, while records stored on the computer's hard drive will be erased using commercial software to remove all data from the storage device. We will use a case record form to record.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-01-02 16:58:35
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