- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05400187
Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hung Hom, Hong Kong
- The Hong Kong Polytechnic University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Body composition assessment and smart-phone based counselling group
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. |
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). |
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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From baseline to 6 months after randomization
|
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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.
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From baseline to 6 months after randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The difference of health eating behavior
Time Frame: From baseline to 6 months after randomization
|
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.
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From baseline to 6 months after randomization
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Weight
Time Frame: From baseline to 6 months after randomization
|
Weight in kg.
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From baseline to 6 months after randomization
|
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Body mass index (BMI)
Time Frame: From baseline to 6 months after randomization
|
BMI in kg/m^2
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From baseline to 6 months after randomization
|
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Waist circumference
Time Frame: From baseline to 6 months after randomization
|
Waist in cm
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From baseline to 6 months after randomization
|
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Hip circumference
Time Frame: From baseline to 6 months after randomization
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Hip in cm
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From baseline to 6 months after randomization
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Thigh circumference
Time Frame: From baseline to 6 months after randomization
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Thigh in cm
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From baseline to 6 months after randomization
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Systolic blood pressure
Time Frame: From baseline to 6 months after randomization
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Systolic blood pressure in mmHg
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From baseline to 6 months after randomization
|
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Diastolic blood pressure
Time Frame: From baseline to 6 months after randomization
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Diastolic blood pressure in mmHg
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From baseline to 6 months after randomization
|
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Body fat percentage
Time Frame: From baseline to 6 months after randomization
|
Body fat percentage was measured by a professional body composition analyzer named InBody 270 in %.
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From baseline to 6 months after randomization
|
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Body fat mass
Time Frame: From baseline to 6 months after randomization
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Body fat mass was measured by a professional body composition analyzer named InBody 270 in kg.
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From baseline to 6 months after randomization
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Collaborators and Investigators
Investigators
- Principal Investigator: Yao Jie Xie, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P0013890
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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