Body Composition Assessment and Smart-phone Based Counselling on Healthy Eating and Weight Management

Healthy Diet Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05400187
• Other study ID #: P0013890
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: May 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We believe that this approach will promote healthy eating behaviors and weight management among middle-aged Chinese in Hong Kong.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Healthy Diet
• Weight Management

Intervention

Behavioral:
• Body composition assessment and smart-phone based counselling
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).

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 6 months after randomization
Primary	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.	From baseline to 6 months after randomization
Secondary	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.	From baseline to 6 months after randomization
Secondary	Weight	Weight in kg.	From baseline to 6 months after randomization
Secondary	Body mass index (BMI)	BMI in kg/m^2	From baseline to 6 months after randomization
Secondary	Waist circumference	Waist in cm	From baseline to 6 months after randomization
Secondary	Hip circumference	Hip in cm	From baseline to 6 months after randomization
Secondary	Thigh circumference	Thigh in cm	From baseline to 6 months after randomization
Secondary	Systolic blood pressure	Systolic blood pressure in mmHg	From baseline to 6 months after randomization
Secondary	Diastolic blood pressure	Diastolic blood pressure in mmHg	From baseline to 6 months after randomization
Secondary	Body fat percentage	Body fat percentage was measured by a professional body composition analyzer named InBody 270 in %.	From baseline to 6 months after randomization
Secondary	Body fat mass	Body fat mass was measured by a professional body composition analyzer named InBody 270 in kg.	From baseline to 6 months after randomization