Weight ManagementNCT05400187
Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management
A study testing Body composition assessment and smart-phone based counselling in people with Weight Management and Healthy Diet, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study proposed an integrated multi-disciplinary approach including a professional and convenient body composition measurement and an immediate counselling after the measurement, followed by 6-month smart-phone based individualized counselling. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Management, Healthy Diet
- What is being tested?
- Body composition assessment and smart-phone based counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to understand Cantonese and read Chinese;
- Self-reported vegetable and fruit consumption is less than 5 servings per day (one serving means 125 mL (½ cup) fresh, frozen or canned fruits or vegetables; or 250 mL (1 cup) raw leafy veggies or salad; or 125 mL (½ cup) 100% juice; or 1 fruit;
- Reachable by smart-phone and familiar with the use of smart-phone;
- Would not move from the local area during the study period.
Who cannot join
- Self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, osteoarthritis, and eating disorder;
- Receiving medically prescribed diet or physical activity intervention;
- For women, currently pregnant;
- Have been taking any medications or long-term supplement such as herbs;
- Cannot provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness on Healthy Eating and Weight Management by Body Composition Assessment and Smart-phone Based Counselling Among Middle-aged Hong Kong Chinese: A 6-month Randomized Controlled Trial
This study proposed an integrated multi-disciplinary approach including a professional and convenient body composition measurement and an immediate counselling after the measurement, followed by 6-month smart-phone based individualized counselling. We believe that this approach will promote healthy eating behaviors and weight management among middle-aged Chinese in Hong Kong.
Read the detailed description
This is a two-arm, individual level, 6-month randomized controlled trial. The intervention group will receive convenient body composition measurement and 6-month smart-phone based individualized counselling. No specific intervention will be given to the control group except the common anthropometric and body composition measurement. A pretest-posttest evaluation and between-group comparison will be used to test whether the impact/success of the project has been achieved.
- Conditions
- Weight Management, Healthy Diet
- Being tested
- Body composition assessment and smart-phone based counselling
- Keywords
- Body Composition Assessment, Smart-phone Based Counselling, Weight Management, Health Eating Behavior, Middle-aged Hong Kong Chinese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body composition assessment and smart-phone based counsellingBehavioural
As for the body composition assessment, body fat and muscle thickness, body fat percentage and distribution will be measured and a brief face-to-face counseling soon after the measurement will be implemented to the participants. Body assessment were measured by the InBody 270 (Biospace, Seoul, Korea) device, which provides a convenient way of accurate body fat measurement comparable with those obtained using air displacement plethysmography (ADP) (about 90% precision).
As for the Whatsapp-based counselling and communication session, qualitative dietary counselling will be offered every two weeks through the Whatsapp. One session contains 15 minutes, including the topics like making a balanced diet (55 % glucose, 30 % lipids and 15 % proteins), diversifying food intake, dietary advices and recommendations in healthy eating behaviors (e.g., eat slowly, eat at a regular time, avoid to skip a meal, drink at least 1.5 L of water each day).
| Study group | Role | What they receive |
|---|---|---|
| Body composition assessment and smart-phone based counselling group | Experimental | In this study, we consider body composition measurement together with an immediate brief counselling after the measurement as part of the intervention. The body composition measurement will allow the participants to get familiar with their own anthropometric data and serve as cues to actions of healthy diet adoption and weight management and control. Based on the measured body fat and anthropometric data, a trained research assistant will give brief individualized dietary and weight management counselling to the participants.
The Whatsapp-based counselling and communication will heighten the awareness through reinforcing the need and benefits of body composition and weight control, the importance of energy balance, as well as providing professional and tailor-made advice on healthy eating and weight management. Qualitative dietary counselling will be offered every two weeks through the Whatsapp. Receives: Behavioral: Body composition assessment and smart-phone based counselling |
| Control group | No intervention | Participants in the control group will receive the simple body composition measurement only, without an immediate counselling after the measurement. Whey will be informed the values of anthropometric data and body composition parameters, no detailed interpretation of the values will be delivered to them. They will also not receive the professional consultant of the healthy diet and weight management from the diatetitian during the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of the weight management belief
Four items from belief domain of Chinese weight management scales (WMS) was used to measure the participants' belief of self weight management . Each item is measured by 3- or 4-point Likert scale. The total score change from 4 to 15 with higher scores indicating better weight management belief.
Measured: From baseline to 6 months after randomization
The difference of the weight management knowledge
The knowledge of weight management was measured by 13 items from the general nutrition knowledge questionnaire (GNKQ). Each item carries one point for a correct answer and the maximum score is 13. A higher score shows better weight management knowledge.
Measured: From baseline to 6 months after randomization
Secondary outcomes (10)
The difference of health eating behavior
Respondents' food knowledge and behavior were obtained through the food behavior questionnaire (FBQ). The FBQ is a questionnaire with 18 questions querying respondents' behaviors and knowledge about various areas of food and diet-related health such as nutrition label reading behaviors, knowledge of diet/disease relationships and some meal consumption patterns.
Measured: From baseline to 6 months after randomization
Weight
Weight in kg.
Measured: From baseline to 6 months after randomization
Body mass index (BMI)
BMI in kg/m^2
Measured: From baseline to 6 months after randomization
Waist circumference
Waist in cm
Measured: From baseline to 6 months after randomization
Hip circumference
Hip in cm
Measured: From baseline to 6 months after randomization
Thigh circumference
Thigh in cm
Measured: From baseline to 6 months after randomization
Systolic blood pressure
Systolic blood pressure in mmHg
Measured: From baseline to 6 months after randomization
Diastolic blood pressure
Diastolic blood pressure in mmHg
Measured: From baseline to 6 months after randomization
Body fat percentage
Body fat percentage was measured by a professional body composition analyzer named InBody 270 in %.
Measured: From baseline to 6 months after randomization
Body fat mass
Body fat mass was measured by a professional body composition analyzer named InBody 270 in kg.
Measured: From baseline to 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight ManagementStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive a convenient body composition measurement and 6-month smart-phone based individualized counselling. Through close collaborations with the experts in nutrition, we can effectively disseminate the knowledge of weight management and control and healthy diet to the middle-aged population. No specific intervention will be given to the control group except the common anthropometric and body composition measurement.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIE Yao Jie Grace, The Hong Kong Polytechnic University
- Investigators
- Yao Jie Xie, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400187
- Sponsor's protocol ID
- P0013890
- Status last verified
- Apr 2025
- First submitted
- 18 May 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang Q, Zhang Y, Liang J, Wang HH, Ma T, Qin J, Xie YJ. Nurse-led counselling and smartphone-based coaching for dietary behaviours, weight management, and cardiometabolic risk in middle-aged Chinese in Hong Kong: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jul 28;25(5):937-950. doi: 10.1093/eurjcn/zvag027.
PubMed 41605251
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness on Healthy Eating and Weight Management by Body Composition Assessment and Smart-phone Based Counselling Among Middle-aged Hong Kong Chinese: A 6-month Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05400187
- Acronym / sponsor ID
- P0013890
- Conditions
- Weight Management, Healthy Diet
- Keywords
- Body Composition Assessment, Smart-phone Based Counselling, Weight Management, Health Eating Behavior, Middle-aged Hong Kong Chinese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposed an integrated multi-disciplinary approach including a professional and convenient body composition measurement and an immediate counselling after the measurement, followed by 6-month smart-phone based individualized counselling. We believe that this approach will promote healthy eating behaviors and weight management among middle-aged Chinese in Hong Kong.
Detailed description
This is a two-arm, individual level, 6-month randomized controlled trial. The intervention group will receive convenient body composition measurement and 6-month smart-phone based individualized counselling. No specific intervention will be given to the control group except the common anthropometric and body composition measurement. A pretest-posttest evaluation and between-group comparison will be used to test whether the impact/success of the project has been achieved.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group will receive a convenient body composition measurement and 6-month smart-phone based individualized counselling. Through close collaborations with the experts in nutrition, we can effectively disseminate the knowledge of weight management and control and healthy diet to the middle-aged population. No specific intervention will be given to the control group except the common anthropometric and body composition measurement.
| Arm | Type | Receives |
|---|---|---|
| Body composition assessment and smart-phone based counselling group | Experimental | Behavioral: Body composition assessment and smart-phone based counsellingIn this study, we consider body composition measurement together with an immediate brief counselling after the measurement as part of the intervention. The body composition measurement will allow the participants to get familiar with their own anthropometric data and serve as cues to actions of healthy diet adoption and weight management and control. Based on the measured body fat and anthropometric data, a trained research assistant will give brief individualized dietary and weight management counselling to the participants. The Whatsapp-based counselling and communication will heighten the awareness through reinforcing the need and benefits of body composition and weight control, the importance of energy balance, as well as providing professional and tailor-made advice on healthy eating and weight management. Qualitative dietary counselling will be offered every two weeks through the Whatsapp. |
| Control group | No intervention | –Participants in the control group will receive the simple body composition measurement only, without an immediate counselling after the measurement. Whey will be informed the values of anthropometric data and body composition parameters, no detailed interpretation of the values will be delivered to them. They will also not receive the professional consultant of the healthy diet and weight management from the diatetitian during the intervention period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand Cantonese and read Chinese;
- Self-reported vegetable and fruit consumption is less than 5 servings per day (one serving means 125 mL (½ cup) fresh, frozen or canned fruits or vegetables; or 250 mL (1 cup) raw leafy veggies or salad; or 125 mL (½ cup) 100% juice; or 1 fruit;
- Reachable by smart-phone and familiar with the use of smart-phone;
- Would not move from the local area during the study period.
Key exclusion criteria (5 listed)
- Self-reported history of cardiovascular and pulmonary diseases, neurological disorder, musculo-skeletal disorder, osteoarthritis, and eating disorder;
- Receiving medically prescribed diet or physical activity intervention;
- For women, currently pregnant;
- Have been taking any medications or long-term supplement such as herbs;
- Cannot provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body composition assessment and smart-phone based counsellingAs for the body composition assessment, body fat and muscle thickness, body fat percentage and distribution will be measured and a brief face-to-face counseling soon after the measurement will be implemented to the participants. Body assessment were measured by the InBody 270 (Biospace, Seoul, Korea) device, which provides a convenient way of accurate body fat measurement comparable with those obtained using air displacement plethysmography (ADP) (about 90% precision). As for the Whatsapp-based counselling and communication session, qualitative dietary counselling will be offered every two weeks through the Whatsapp. One session contains 15 minutes, including the topics like making a balanced diet (55 % glucose, 30 % lipids and 15 % proteins), diversifying food intake, dietary advices and recommendations in healthy eating behaviors (e.g., eat slowly, eat at a regular time, avoid to skip a meal, drink at least 1.5 L of water each day). | Behavioural | Body composition assessment and smart-phone based counselling group |
Primary outcome
The difference of the weight management belief
Time frame: From baseline to 6 months after randomization
Four items from belief domain of Chinese weight management scales (WMS) was used to measure the participants' belief of self weight management . Each item is measured by 3- or 4-point Likert scale. The total score change from 4 to 15 with higher scores indicating better weight management belief.
The difference of the weight management knowledge
Time frame: From baseline to 6 months after randomization
The knowledge of weight management was measured by 13 items from the general nutrition knowledge questionnaire (GNKQ). Each item carries one point for a correct answer and the maximum score is 13. A higher score shows better weight management knowledge.
10 secondary outcomes
The difference of health eating behavior
Time frame: From baseline to 6 months after randomization
Weight
Time frame: From baseline to 6 months after randomization
Body mass index (BMI)
Time frame: From baseline to 6 months after randomization
Waist circumference
Time frame: From baseline to 6 months after randomization
Hip circumference
Time frame: From baseline to 6 months after randomization
Thigh circumference
Time frame: From baseline to 6 months after randomization
Systolic blood pressure
Time frame: From baseline to 6 months after randomization
Diastolic blood pressure
Time frame: From baseline to 6 months after randomization
Body fat percentage
Time frame: From baseline to 6 months after randomization
Body fat mass
Time frame: From baseline to 6 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 41605251Yang Q, Zhang Y, Liang J, Wang HH, Ma T, Qin J, Xie YJ. Nurse-led counselling and smartphone-based coaching for dietary behaviours, weight management, and cardiometabolic risk in middle-aged Chinese in Hong Kong: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jul 28;25(5):937-950. doi: 10.1093/eurjcn/zvag027.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Jie Xie, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body composition assessment and smart-phone based counselling in people with Weight Management and Healthy Diet, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of the weight management belief (time frame: From baseline to 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.