NCT07379970

Effects of Wearable Device Functions and Health Coaching on Device-measured Movement Behaviours and Cardiometabolic Risk Factors in Adults With Central Obesity

Recruiting now NA Last updated 2 February 2026

What this trial tests

NA trial testing Fitbit Wearable Device in Fitness Trackers in 133 participants. Currently enrolling.

Timeline

1 January 2025

Primary endpoint
1 June 2027

31 December 2027

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	133
Start date	1 January 2025
Primary completion	1 June 2027
Estimated completion	31 December 2027
Sites	1 location across Hong Kong

Drugs / interventions tested

• Fitbit Wearable Device
• Lifestyle Coaching Program

Conditions studied

• Fitness Trackers — all drugs for Fitness Trackers →
• Cardio Vascular Disease — all drugs for Cardio Vascular Disease →
• Physical Activities — all drugs for Physical Activities →
• Exercise — all drugs for Exercise →

Sponsor

The University of Hong Kong

Who can join

40 and older, any sex, with Fitness Trackers or Cardio Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a randomized controlled trial. The objective of this study is to investigate:

1. the effects of 1-year evidence-based interventions incorporating wearable device functions alone on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity; and
2. the effects of 1-year evidence-based interventions incorporating wearable device functions combined with health coaching on device-measured movement behaviours and cardiometabolic risk factors among adults with central obesity.

We hypothesise that the use of wearable device functions in combination with health coaching will lead to significantly greater improvements in device-measured movement behaviours and cardiometabolic risk factors compared with no intervention and wearable device functions alone, both after the 12-month intervention and at the 6-month follow-up.

This study will implement a parallel-group, open-label, 1-year randomized controlled trial involving 133 adults aged 40 years or older with central obesity. The trial will examine the effects of a cutting-edge intervention using evidence-based wearable device functions alone or in combination with evidence-based health coaching on movement behaviours and cardiometabolic risk factors.

All participants will provide written informed consent prior to participation and will be informed that they may withdraw from the study at any time during the study period. A staff member without access to participant information will generate a computer-based randomization list using permuted blocks of six, with two participants allocated to each of the three groups (two intervention groups and one control group) per block, in a 2:2:2 allocation ratio.

The control group will not receive a Fitbit device and will be asked to continue their usual lifestyle. The two intervention groups will use four evidence-based Fitbit functions: step goal setting, sleep goal setting, activity prompts, and community functions. The key difference between the two intervention groups is that one group will additionally receive a structured health coaching program adapted from the U.S. Centers for Disease Control and Prevention (CDC) National Diabetes Prevention Program (NDPP), as used in our prior trial.

The CDC NDPP recommends that at least 22 health coaching sessions be delivered over a 1-year period, depending on participants' needs, and provides corresponding curricula and handouts outlining session content. Coaching sessions will be delivered by trained research staff who have received appropriate professional training in health coaching delivery.

The lifestyle change program will include, but not be limited to:

1. education on cardiometabolic disease risk factors (e.g., type 2 diabetes, coronary heart disease, and stroke);
2. goal planning and goal setting;
3. strategies for self-monitoring physical activity, sleep, diet, and stress;
4. strategies for initiating and maintaining favourable levels of physical activity, diet, and sleep;
5. strategies for obtaining support from family, friends, and co-workers; and
6. review of achievements and challenges during the intervention period, with goal setting and planning for the subsequent 6-month follow-up period.

Participants will attend the research laboratory on three occasions: at baseline, immediately after the 12-month intervention, and at the 6-month follow-up. Assessments will include demographic information, standing height, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio, systolic and diastolic blood pressure, and questionnaires.

At each laboratory visit, one EDTA blood sample and one clotted blood sample will be collected by a trained phlebotomist and analysed by an accredited medical diagnostic centre to assess cardiometabolic risk markers, including total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides.

An Axivity AX6 device will be used as a research-grade accelerometer to assess movement behaviours, including sleep, sedentary time, light physical activity, moderate-to-vigorous physical activity (MVPA), steps, energy expenditure, and resting heart rate. Participants will also be asked to wear the Axivity device on the dominant wrist for seven consecutive days at baseline and post-intervention.

Research staff will access participants' Fitbit web accounts to extract Fitbit data, activate Fitbit functions for the intervention groups, and monitor device battery life. Reminders to wear and charge the Fitbit and research-grade accelerometer will be sent every seven days via WhatsApp to promote protocol compliance. To further support adherence, participants who complete all study assessments will receive a HKD 500 supermarket voucher.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.