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Prevention of NCDs Through Screening and Educating Individuals on Health-risk Behaviours in the Community

Primary Purpose

Health-risk Behaviours, Non Communicable Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Theory of planned behaviour, foot-in-the-door technique, and self-determination theory intervention
health-risk behaviors
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Health-risk Behaviours focused on measuring Health-risk Behaviours, Non Communicable Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chinese adults in Kwai Chung Estate: age ≥18 years the presence of at least one health risk behaviour (tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity) able to communicate in Cantonese Nursing students: age ≥18 years Year 2 to 5 Exclusion Criteria: poor cognitive state or mental illness participation in another related study.

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

The participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. The participants will receive a brief telephone intervention using the Ask, Warn, Advise, Refer and Do-it-again (AWARD) model. For the advice step, the research assistant will ask about the priority the participants place on engagement in desirable health-related lifestyle practices identified in the completed behavioural risk factor survey. The participants will also be asked to choose the goal that they consider easiest to achieve, such as quitting or reducing smoking, consuming more vegetables or less fatty foods or sugary drinks, performing more exercise or reducing alcohol consumption. The participants will be encouraged to quit health-risk behaviours (or adopt a healthy lifestyle) sequentially, but they will also be able to choose to quit them simultaneously if they are confident in doing so.

The control group participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. However, the health ambassadors will simply advise the participants to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group.

Outcomes

Primary Outcome Measures

Abstain from health-risk behaviour
About 10% of participants will successfully abstain from at least one health-risk behaviour at 12-month follow-up

Secondary Outcome Measures

Reduction in health-risk behaviours
Reduction in health-risk behaviours (≥ 50% reduction from baseline) at 12-month follow-up
Improvement in health-related quality of life
Improvement in health-related quality of life at 12-month follow-up compare to baseline using questionnaires
Ambassadors' knowledge and skill on providing professional health advice and support to participants about changing their health-risk behaviours
Improvement of ambassadors' knowledge and skill on providing professional health advice and support to participants about changing their health-risk behaviours by comparing pre-, post-training and 6-month evaluation questionnaires.
Improvement in blood pressure
Improvement in blood pressure at 12-month follow-up compare to baseline
Improvement in body mass index
Improvements in body mass index at 12-month follow-up compare to baseline

Full Information

First Posted
March 16, 2023
Last Updated
August 10, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05790395
Brief Title
Prevention of NCDs Through Screening and Educating Individuals on Health-risk Behaviours in the Community
Official Title
Prevention of Non-communicable Diseases Through Screening and Educating Individuals on Health-risk Behaviours in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim: to prevent NCDs by screening and educating individuals in the community on health-risk behaviours. Specifically, we will use a mobile health and a brief self-determination theory-based intervention in helping individual change their health-risk behaviours. Hypotheses to be tested: compared with those in the control group, the participants in the intervention group will experience significantly greater success in modifying their health-risk behaviours and will have a better health-related quality of life at 12 months follow-up. Objectives To screen individuals for health-risk behaviours and identify risk factors that may contribute to NCDs To educate individuals on the importance of engaging in healthy lifestyles To develop a training programme - "Train the Trainers' Toolkit", with the goal to train student nurses (Years 2 to 5) as health ambassadors to implement the project on a long-term basis.
Detailed Description
Setting: The project will be carried out in Kwai Chung Estate, one of the largest public housing estates with many low-income families in Hong Kong. The project consists of four phases. Phase I: To invite 30 university nursing students (Year 2 to 5) to become health ambassadors for the prevention of NCDs in the community. Phase II: To develop a training curriculum and conduct a one-day workshop for university nursing students to equip them with knowledge and skills to perform screening for individuals' health-risk behaviours and educating them to adopt healthy lifestyles. Phase III: To recruit 300 individuals (150 each in intervention and control groups) in Kwai Chung Estate with the aims of screening and educating health-risk behaviours and identifying risk factors that may contribute to NCDs. Activities will include putting up posters and organizing a health carnival with health education talks and health checks. Asbury Methodist Social Service will help: Promotion activities (promotional posters detailing the nature and purpose of the health promotion project will be posted on notice boards at The Asbury Methodist Social Service Centres to identify potential participants) Provide venues for health talks and health checks for subject recruitment Co-organize a health carnival for subject recruitment Phase IV: To implement a mobile health brief intervention based on self-determination theory in helping individual change their health-risk behaviours. Intervention: Participants will first assess for risky behaviours using a behavioural risk factor survey. In addition, their blood pressure, body weight, height, body mass index (BMI), and health-related quality of life will be assessed. Intervention group Participants will then receive a brief intervention by trained health ambassadors using the Ask, Warn, Advise, Refer and Do-it-again (AWARD) model at the time of recruitment. The brief intervention includes the following steps: (1) ask about and assess health-risk behaviours; (2) warn about the high morbidity and mortality risks associated with health-risk behaviours; (3) advise to adopt healthy lifestyle practices to benefit the health; (4) refer to hotline services on request, such as smoking cessation, alcohol treatment services and district health centres; and (5) do it again if they report failure to change a health-risk behaviour at follow-up. The health ambassadors will ask about the priority the participants place on engagement in desirable health-related lifestyle practices identified in the completed behavioural risk factor survey. The participants will also be asked to choose the goal that they consider easiest to achieve, such as quitting or reducing smoking, consuming more vegetables or less fatty foods or sugary drinks, performing more exercise or reducing alcohol consumption. The participants will be encouraged to quit health-risk behaviours (or adopt a healthy lifestyle) sequentially, but they will also be able to choose to quit them simultaneously if they are confident in doing so. Each participant will then receive a brief (approximately 10 minutes), individual intervention with health advice about the selected health-related lifestyle practice. The participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications, including (i) 'Move Your Body', (ii) 'Eat Healthy', (iii) 'Live Alcohol Free', and (iv) 'Stay Away from Tobacco', which were developed by the Hong Kong Department of Health. For the first 6 months of the project period, the health ambassadors will deliver WhatsApp/WeChat messages about once per week as a reminder for the participants to adhere to their desirable health-related lifestyle practice. If a participant does not own a smartphone or is unable to receive WhatsApp/WeChat messages (uncommon in Hong Kong), the health ambassadors will make a telephone call, instead of sending a message. Participants will be assessed to determine their success in changing their targeted health-related lifestyle practice at 3, 6, and 12 months. Control group The control group participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. However, the health ambassadors will simply advise the participants to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group. Subject recruitment The investigators will obtain ethical approval from the Joint CUHK-NTEC CREC. Potential participants will be assessed for eligibility, and the purpose, design, procedures, and potential benefits and risks of the study will be explained to them. Informed written consent will then be sought. All subjects will be assured that their participation will be voluntary, with no prejudice attached to refusal, and that the information they provide will be kept confidential. The researcher is responsible for its safekeeping and the only one who would have access to the raw data or study record during or after the study. After the period of storage, all raw data and records will be destroyed. The proposed study will adhere to the Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Randomization and allocation concealment Stratified block randomisation with 1:1 allocation will be conducted using varying block sizes of 2-4 to achieve an appropriate balance of participant numbers between the two groups and to optimise allocation concealment. Randomization will be performed by the research assistant, who will unseal a serially labelled, opaque envelope containing a card to indicate the group allocation. To ensure allocation concealment, the random numbers used for allocation will be computer-generated by a co-investigator before subject recruitment. Data processing and analysis Instruments: A behavioural risk-factor survey will be used to collect the eligible participants' demographic and clinical data and information about their health-risk behaviours at baseline and at 3, 6, and 12 months. This questionnaire is adapted from a questionnaire used by the Hong Kong Department of Health and was used to investigate multiple health-risk behaviours among Chinese adults in Hong Kong in 2021. The EuroQoL 5-Dimension 5-level (EQ-5D-5L) will be used to measure subjects' health-related quality of life at baseline, 6 months, and 12 months. The psychometric properties of the Chinese version of the EQ-5D-5L have been tested, and the findings indicate that this tool is a valid, reliable, and sensitive measure of health-related quality of life. A Chinese-specific EQ-5D-5L value set will enable the estimation of health utility scores applicable to the Chinese population and quality-adjusted life-years (QALY) for cost-effectiveness analysis (CEA). SPSS for Windows (SPSS version 26.0; IBM Corp., Armonk, NY, USA) will be used for the quantitative data analysis. Descriptive statistics will be used to calculate the mean, standard deviation, and frequency of the demographic and health-risk behaviour data. The analysis including the main effect, i.e., behavioural changes at 12 months in the intervention group versus those in the control group, will be performed using a chi-square test or Fisher's exact test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health-risk Behaviours, Non Communicable Diseases
Keywords
Health-risk Behaviours, Non Communicable Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. The participants will receive a brief telephone intervention using the Ask, Warn, Advise, Refer and Do-it-again (AWARD) model. For the advice step, the research assistant will ask about the priority the participants place on engagement in desirable health-related lifestyle practices identified in the completed behavioural risk factor survey. The participants will also be asked to choose the goal that they consider easiest to achieve, such as quitting or reducing smoking, consuming more vegetables or less fatty foods or sugary drinks, performing more exercise or reducing alcohol consumption. The participants will be encouraged to quit health-risk behaviours (or adopt a healthy lifestyle) sequentially, but they will also be able to choose to quit them simultaneously if they are confident in doing so.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications. However, the health ambassadors will simply advise the participants to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group.
Intervention Type
Other
Intervention Name(s)
Theory of planned behaviour, foot-in-the-door technique, and self-determination theory intervention
Intervention Description
The participants will also be asked to choose the goal that they consider easiest to achieve and encouraged to quit health-risk behaviours. The research assistant will assist in achieving the participant's health-related goals by sending WhatsApp/WeChat messages or via telephone calls once per week for the first 6 months.
Intervention Type
Other
Intervention Name(s)
health-risk behaviors
Intervention Description
The participants will be simply advised to modify their health-risk behaviours and/or adopt a healthy lifestyle practice. The participants will also receive follow-up for outcome assessments with the same schedule as those in the intervention group.
Primary Outcome Measure Information:
Title
Abstain from health-risk behaviour
Description
About 10% of participants will successfully abstain from at least one health-risk behaviour at 12-month follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction in health-risk behaviours
Description
Reduction in health-risk behaviours (≥ 50% reduction from baseline) at 12-month follow-up
Time Frame
12 months
Title
Improvement in health-related quality of life
Description
Improvement in health-related quality of life at 12-month follow-up compare to baseline using questionnaires
Time Frame
12 months
Title
Ambassadors' knowledge and skill on providing professional health advice and support to participants about changing their health-risk behaviours
Description
Improvement of ambassadors' knowledge and skill on providing professional health advice and support to participants about changing their health-risk behaviours by comparing pre-, post-training and 6-month evaluation questionnaires.
Time Frame
6 months
Title
Improvement in blood pressure
Description
Improvement in blood pressure at 12-month follow-up compare to baseline
Time Frame
12 months
Title
Improvement in body mass index
Description
Improvements in body mass index at 12-month follow-up compare to baseline
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese adults in Kwai Chung Estate: age ≥18 years the presence of at least one health risk behaviour (tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity) able to communicate in Cantonese Nursing students: age ≥18 years Year 2 to 5 Exclusion Criteria: poor cognitive state or mental illness participation in another related study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Cheung William Li, PhD
Phone
39430889
Email
williamli@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Cheung William Li, PhD
Phone
39430889
Email
williamli@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
IPD Sharing Time Frame
After the project has been completed and the results of the project has been published
IPD Sharing Access Criteria
Request could be sent to Principal Investigator (williamli@cuhk.edu.hk)

Learn more about this trial

Prevention of NCDs Through Screening and Educating Individuals on Health-risk Behaviours in the Community

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