This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health.
Chronic non-communicable diseases (NCDs), including cardiovascular diseases, cancer, chronic respiratory diseases and diabetes, are an important public health concern worldwide. Physical inactivity is one of the major contributing factors which is highly correlated with the prevalence of NCDs. On the other hand, it is well known that increased physical activity has significant health benefits and is associated with the prevention and delayed onset of many NCDs. Given the important role of physical activity in the prevention and management of NCDs it is thus important to promote physical activity. Hence, to date a multitude of physical activity recommendations and many supervised training interventions and rehabilitation programs are available to encourage physical activity in the global population. Despite this, a recent report from the World Health Organization (WHO) indicates that 23% of the adult and 80% of the adolescent population remains physically inactive. Here, long-term compliance to adequate physical activity and a healthy life style appears to be one of the main barriers explaining this discrepancy. Consequently, any strategy that improves long term adherence to adequate daily physical activity and a healthy life style, especially in an NCD population, is worthwhile investigating. In this respect and following the recent use of accelerometer-based remote monitoring of physical activity in chronic disease patients, consumer wearable activity trackers may be such a strategy. So far, consumer wearable activity trackers have been investigated mainly in the sports community. Here CWATs are used for self-monitoring and providing continuous sport performance and health related information to athletes and coaches. Interestingly, the self-management, motivational and goal setting properties of these commercially available devices may also help patients with NCDs to engage in long-term physical activity under free-living conditions in a home-based setting. Despite the widespread use of these wearables their feasibility and effectiveness on physical activity (compliance) and generic health-related outcomes, including weight, body mass index (BMI), systemic blood pressure and glycemic index, especially in patients with NCDs is not fully clear. Therefore, the aim of this study is to investigate the effectiveness of CWATs to promote physical activity levels and cardiometabolic health in sedentary adults. A better understanding to what extent CWATs can actually improve physical activity (compliance) and health outcomes is important to increase the effectiveness and quality of health care in chronic disease populations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Participant in the intervention group will wear an activity tracker for 12 weeks.
Participant in the intervention group will wear an activity tracker for 12 weeks and are also motivated by the researcher via a lifestyle data platform.
Hasselt University
Diepenbeek, Limburg, Belgium
Steps per day
Physical activity will be quantified using the activPAL3™ activity monitor.
Time frame: Baseline
sitting time
sedentary behaviour will be quantified using the activPAL3™ activity monitor.
Time frame: baseline
Steps per day
Physical activity will be quantified using the activPAL3™ activity monitor.
Time frame: week 12
sitting time
sedentary behaviour will be quantified using the activPAL3™ activity monitor.
Time frame: week 12
body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Time frame: baseline
body weight
Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
Time frame: week 12
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Time frame: baseline
Height
Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
Time frame: week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Time frame: baseline
DEXA (Dual Energy X-Ray)
body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
Time frame: week 12
Concentration of glucose
Blood analysis
Time frame: baseline
Concentration of glucose
Blood analysis
Time frame: week 12
Concentration of Insuline
Blood analysis
Time frame: baseline
Concentration of Insuline
Blood analysis
Time frame: week 12
Concentration of total cholesterol
Blood analysis
Time frame: baseline
total cholesterol
Blood analysis
Time frame: week 12
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Time frame: baseline
Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
Blood analysis
Time frame: week 12
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Time frame: baseline
Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
Blood analysis
Time frame: week 12
Concentration of triglyceride
Blood analysis
Time frame: baseline
Concentration of triglyceride
Blood analysis
Time frame: week 12
Concentration of glycated haemoglobin (HbA1c)
Blood analysis
Time frame: baseline
Concentration of glycated haemoglobin (HbA1c)
Blood analysis
Time frame: week 12
Concentration of uric acid
Blood analysis
Time frame: baseline
Concentration of uric acid
Blood analysis
Time frame: week 12
Concentration of interleukin 6 (IL-6),
Blood analysis
Time frame: baseline
Concentration of interleukin 6 (IL-6),
Blood analysis
Time frame: week 12
Concentration of tumor necrosis factor-alpha (TNF-α),
Blood analysis
Time frame: baseline
Concentration of tumor necrosis factor-alpha (TNF-α),
Blood analysis
Time frame: week 12
Concentration of C-reactive protein (CRP)
Blood analysis
Time frame: baseline
Concentration of C-reactive protein (CRP)
Blood analysis
Time frame: week 12
Concentration of serum amyloid A (SAA)
Blood analysis
Time frame: baseline
Concentration of serum amyloid A (SAA)
Blood analysis
Time frame: week 12
Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
Blood analysis
Time frame: baseline
Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
Blood analysis
Time frame: week 12
Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
Blood analysis
Time frame: baseline
Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
Blood analysis
Time frame: week 12
Concentration of soluble E-selectin (sE-selectin).
Blood analysis
Time frame: baseline
Concentration of soluble E-selectin (sE-selectin).
Blood analysis
Time frame: week 12
Vascular endothelial function
Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device
Time frame: baseline
Vascular endothelial function
Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device
Time frame: week 12
Homeostatic model assessment for insulin resistance (HOMA-IR)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the homeostatic model assessment for insulin resistance (HOMA-IR). The HOMA-IR is calculated from the fasting insulin and glucose concentration.sensitivity and beta cell function. The following parameters are calculated: homeostatic model assessment for insulin resistance, whole-body insulin sensitivity index, insulinogenic index and the area under the curve for glucose and insulin.
Time frame: baseline
Homeostatic model assessment for insulin resistance (HOMA-IR)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the homeostatic model assessment for insulin resistance (HOMA-IR). The HOMA-IR is calculated from the fasting insulin and glucose concentration.sensitivity and beta cell function. The following parameters are calculated: homeostatic model assessment for insulin resistance, whole-body insulin sensitivity index, insulinogenic index and the area under the curve for glucose and insulin.
Time frame: week 12
Whole-body insulin sensitivity index (ISI)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the whole-body insulin sensitivity index (ISI). The ISI is calculated from both insulin and glucose concentrations.
Time frame: baseline
Whole-body insulin sensitivity index (ISI)
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity using the whole-body insulin sensitivity index (ISI). The ISI is calculated from both insulin and glucose concentrations.
Time frame: week 12
Area under the curve of insulin concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of insulin concentrations.
Time frame: baseline
Area under the curve of insulin concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of insulin concentrations.
Time frame: week 12
Area under the curve of glucose concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of glucose concentrations.
Time frame: baseline
Area under the curve of glucose concentrations
An oral glucose tolerance test will be performed for assessment of whole body insulin sensitivity by calculation of the area under the curve of glucose concentrations.
Time frame: week 12
Insulinogenic index
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
Time frame: baseline
Insulinogenic index
An oral glucose tolerance test will be performed for assessment of beta cell function by calculation of the insulinogenic index. The insulinogenic index is calculated from both insulin and glucose concentrations.
Time frame: week 12
Cardiac autonomic function
Cardiac autonomic function will be operationalized as heart rate variability by means of continuous beat-to-beat heart rate signal measurements. time domain and frequency domain analysis of the R-R intervals will be performed
Time frame: baseline
Cardiac autonomic function
Cardiac autonomic function will be operationalized as heart rate variability by means of continuous beat-to-beat heart rate signal measurements. time domain and frequency domain analysis of the R-R intervals will be performed
Time frame: week 12
Systolic and Diastolic Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
Time frame: baseline
Systolic and Diastolic Blood pressure
Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
Time frame: week 12
Oxygen uptake (VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Oxygen uptake (VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Carbon dioxide output (VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Carbon dioxide output (VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Minute ventilation (VE)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Minute ventilation (VE)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Equivalents for oxygen uptake (VE/VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Equivalents for oxygen uptake (VE/VO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Equivalents for carbon dioxide production (VE/VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Equivalents for carbon dioxide production (VE/VCO2)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis VE/VCO2 is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Tidal volume (Vt)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Tidal volume (Vt)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis Vt is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Breathing frequency (BF)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Breathing frequency (BF)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis BF is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Time frame: baseline
Respiratory gas exchange ratio (RER)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of continuous pulmonary gas exchange analysis RER is collected breath-by-breath and averaged every ten seconds.
Time frame: week 12
Heart rate (HR)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of a heart rate monitor the HR is measured and averaged every ten seconds.
Time frame: baseline
Heart rate (HR)
Cardiopulmonary exercise test on an electronically braked cycle ergometer is performed. With the aid of a heart rate monitor the HR is measured and averaged every ten seconds.
Time frame: week 12
A six-minute walk test
The covered distance is measured during a six-minute walk test.
Time frame: baseline
A six-minute walk test
The covered distance is measured during a six-minute walk test.
Time frame: week 12
Relative autonomy index
Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).
Time frame: baseline
Relative autonomy index
Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).
Time frame: week 12
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: baseline
Total calorie intake
Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
Time frame: week 12
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: baseline
Macronutrient content
Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Time frame: week 12