Back to resultsBody Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management
Primary Purpose
Weight Management, Healthy Diet
Status
Active
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Body composition assessment and smart-phone based counselling
Sponsored by
About this trial
This is an interventional prevention trial for Weight Management focused on measuring Body Composition Assessment, Smart-phone Based Counselling, Weight Management, Health Eating Behavior, Middle-aged Hong Kong Chinese
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- The Hong Kong Polytechnic University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Body composition assessment and smart-phone based counselling group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Weight
Weight in kg.
Body mass index (BMI)
BMI in kg/m^2
Waist circumference
Waist in cm
Hip circumference
Hip in cm
Thigh circumference
Thigh in cm
Systolic blood pressure
Systolic blood pressure in mmHg
Diastolic blood pressure
Diastolic blood pressure in mmHg
Body fat percentage
Body fat percentage was measured by a professional body composition analyzer named InBody 270 in %.
Body fat mass
Body fat mass was measured by a professional body composition analyzer named InBody 270 in kg.
Full Information
NCT ID
NCT05400187
First Posted
May 18, 2022
Last Updated
May 26, 2022
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05400187
Brief Title
Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Anticipated)
Study Completion Date
August 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Management, Healthy Diet
Keywords
Body Composition Assessment, Smart-phone Based Counselling, Weight Management, Health Eating Behavior, Middle-aged Hong Kong Chinese
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
During the randomization session, the generated random numbers will be placed in opaque and tamperproof envelopes and sealed. Another independent person (other than statistician) will open all envelopes for eligible participants and responsible for arranging participants to undertake their corresponding treatments. Participants, investigators, and statistician will be concealed about the random allocation until each participant has been registered and the assignments have been made. The research assistant who will perform the outcome measures and the statistician are blinded to treatment group assignment.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Body composition assessment and smart-phone based counselling group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body composition assessment and smart-phone based counselling
Intervention Description
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).
Primary Outcome Measure Information:
Title
The difference of the weight management belief
Description
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.
Time Frame
From baseline to 6 months after randomization
Title
The difference of the weight management knowledge
Description
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.
Time Frame
From baseline to 6 months after randomization
Secondary Outcome Measure Information:
Title
The difference of health eating behavior
Description
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.
Time Frame
From baseline to 6 months after randomization
Title
Weight
Description
Weight in kg.
Time Frame
From baseline to 6 months after randomization
Title
Body mass index (BMI)
Description
BMI in kg/m^2
Time Frame
From baseline to 6 months after randomization
Title
Waist circumference
Description
Waist in cm
Time Frame
From baseline to 6 months after randomization
Title
Hip circumference
Description
Hip in cm
Time Frame
From baseline to 6 months after randomization
Title
Thigh circumference
Description
Thigh in cm
Time Frame
From baseline to 6 months after randomization
Title
Systolic blood pressure
Description
Systolic blood pressure in mmHg
Time Frame
From baseline to 6 months after randomization
Title
Diastolic blood pressure
Description
Diastolic blood pressure in mmHg
Time Frame
From baseline to 6 months after randomization
Title
Body fat percentage
Description
Body fat percentage was measured by a professional body composition analyzer named InBody 270 in %.
Time Frame
From baseline to 6 months after randomization
Title
Body fat mass
Description
Body fat mass was measured by a professional body composition analyzer named InBody 270 in kg.
Time Frame
From baseline to 6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yao Jie Xie, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong
12. IPD Sharing Statement
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Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management
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