NCT05400187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

May 18, 2022

Last Update Submit

April 6, 2025

Conditions

Keywords

Body Composition AssessmentSmart-phone Based CounsellingWeight ManagementHealth Eating BehaviorMiddle-aged Hong Kong Chinese

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (10)

  • The difference of health eating behavior

    From baseline to 6 months after randomization

  • Weight

    From baseline to 6 months after randomization

  • Body mass index (BMI)

    From baseline to 6 months after randomization

  • Waist circumference

    From baseline to 6 months after randomization

  • Hip circumference

    From baseline to 6 months after randomization

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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).

Body composition assessment and smart-phone based counselling group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (1)

  • Yang Q, Zhang Y, Liang J, Wang HH, Ma T, Qin J, Xie YJ. Nurse-led counselling and smartphone-based coaching for dietary behaviors, weight management and cardiometabolic risk in middle-aged Chinese in Hong Kong: a randomized controlled trial. Eur J Cardiovasc Nurs. 2026 Jan 29:zvag027. doi: 10.1093/eurjcn/zvag027. Online ahead of print.

Study Officials

  • Yao Jie Xie, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2022

First Posted

June 1, 2022

Study Start

June 1, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 8, 2025

Record last verified: 2025-04

Locations