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

Official title

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

Overview

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.

Interventions

• Device Fitbit Wearable 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.
• Behavioral Lifestyle Coaching Program
  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 ch

Primary outcome measures

• 24-hour Movement Behavior Composition (Accelerometer-derived) [Time frame: Baseline, 12-month post-intervention]

Secondary outcome measures (4)

• Body Weight [Time frame: Baseline, 12 months]
• Waist Circumference [Time frame: Baseline, 12 months]
• Blood Pressure [Time frame: Baseline, 12 months]
• Blood Lipid Profile [Time frame: Baseline, 12 months]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Hong Kong · 1 center

• Exercise Physiology Lab, The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07379970 · healthcoachingrct

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗