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

NCT07379970 | Recruiting

• 1 other identifier: healthcoachingrct
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Fitness Trackers; Cardio Vascular Disease; Physical Activities; Exercise; Health Coaching

Keywords

movement behavior; NDPP Program; randomized controlled trial; wearable technology

Outcome Measures

Primary Outcomes (1)

• 24-hour Movement Behavior Composition (Accelerometer-derived)

  The primary outcome is the 24-hour composition of movement behaviors, defined as the relative distribution of time spent in sedentary behavior, light physical activity, moderate-to-vigorous physical activity (MVPA), and sleep within a 24-hour period. These components will be derived from accelerometer data and jointly analyzed as a single compositional outcome using compositional data analysis methods.

  Baseline, 12-month post-intervention

Secondary Outcomes (4)

• Body Weight

  Baseline, 12 months

• Waist Circumference

  Baseline, 12 months

• Blood Pressure

  Baseline, 12 months

• Blood Lipid Profile

  Baseline, 12 months

Study Arms (3)

Usual Care Control

NO INTERVENTION

Participants will continue their usual lifestyle without receiving a wearable device or behavioral intervention.

Fitbit Only

EXPERIMENTAL

Participants will receive a Fitbit wearable device and use selected Fitbit functions related to physical activity and sleep.

Device: Fitbit Wearable Device

Fitbit + Lifestyle Coaching

EXPERIMENTAL

Participants will receive a Fitbit wearable device and participate in a structured lifestyle coaching program adapted from the U.S. CDC National Diabetes Prevention Program (NDPP).

Behavioral: Lifestyle Coaching Program

Interventions

Fitbit Wearable Device DEVICE

Participants will use a Fitbit wearable device with the following evidence-based functions enabled: step goal setting (10% higher than baseline daily steps), sleep goal setting (8 hours per day), activity prompts (vibration alert when fewer than 250 steps are accumulated per hour), and community features such as activity or exercise challenges. These functions support self-monitoring, goal setting, prompts, feedback, and social support.

Fitbit Only

Lifestyle Coaching Program BEHAVIORAL

Participants will receive a structured lifestyle coaching program adapted from the U.S. Centers for Disease Control and Prevention National Diabetes Prevention Program (NDPP). The program includes at least 22 coaching sessions delivered over approximately 12 months. Sessions focus on cardiometabolic disease risk factors, goal setting, self-monitoring of physical activity, sleep, diet, and stress, strategies to initiate and maintain healthy behaviors, social support, and review of progress and challenges.

Fitbit + Lifestyle Coaching

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 years or older
• Central obesity, defined as waist circumference: ≥90 cm for men; ≥80 cm for women
• Insufficient physical activity based on World Health Organization (WHO) guidelines
• Physical activity assessed using the International Physical Activity Questionnaire (IPAQ) - Short Form
• Ownership of a smartphone
• Able to read and understand English or Chinese

You may not qualify if:

• unable to perform daily-life activities, based on the Physical Activity Readiness-Questionnaire (PAR-Q) (24) and/or participation in another lifestyle-change intervention study.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Exercise Physiology Lab, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Youngwon Kim

CONTACT

852 28315252; youngwon.kim@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (for preparation of corresponding e-leaflets, lifestyle coaching courses and baseline Fitbit step goal calculations), and from participants until the interventions are delivered. Given the nature of the interventions delivered, it will be impossible for participants to be blinded to the specific intervention they receive once the initial interventions are provided; however, study staff analyzing participants' de-identified data will remain blinded to participant randomization assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: parallel-group, open randomized controlled trial

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The datasets analysed during the current study and statistical code will be available after the completion of the study
• Access Criteria: IPD data can be accessed based on reasonable request by contacting the corresponding author.

Locations

HK (1)