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

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05400187

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Management Healthy Diet	Behavioral: Body composition assessment and smart-phone based counselling	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Investigator, Outcomes 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.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Aug 20, 2022

Anticipated Study Completion Date :

Aug 20, 2022

Arms and Interventions

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.	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).
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.

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.

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).

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.

Outcome Measures

Primary Outcome Measures

The difference of the weight management belief [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 [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.

Secondary Outcome Measures

The difference of health eating behavior [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.
Weight [From baseline to 6 months after randomization]
Weight in kg.
Body mass index (BMI) [From baseline to 6 months after randomization]
BMI in kg/m^2
Waist circumference [From baseline to 6 months after randomization]
Waist in cm
Hip circumference [From baseline to 6 months after randomization]
Hip in cm
Thigh circumference [From baseline to 6 months after randomization]
Thigh in cm
Systolic blood pressure [From baseline to 6 months after randomization]
Systolic blood pressure in mmHg
Diastolic blood pressure [From baseline to 6 months after randomization]
Diastolic blood pressure in mmHg
Body fat percentage [From baseline to 6 months after randomization]
Body fat percentage was measured by a professional body composition analyzer named InBody 270 in %.
Body fat mass [From baseline to 6 months after randomization]
Body fat mass was measured by a professional body composition analyzer named InBody 270 in kg.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.