Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults

Study Overview
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Brief Summary
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This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health.

Detailed Description
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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.

Official Title
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The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults

Conditions
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Sedentary Lifestyle

Intervention / Treatment
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* Device: CWAT intervention
* Device: CWAT + motivation intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sedentary adults 40-75 years, <7500steps/day, sitting time of >10h/day, BMI 23-30 kg/m2, body fat percentage: male: 18-25%, female: 25-35% HbA1c < 6.0% Exclusion Criteria: pregnancy, regularly (>150 min per week during the last four months) engaged in moderate-to-vigorous intensity exercise, any known contradiction for physical activity, systolic blood pressure >160mmHg, diastolic blood pressure >100mmHg more than 20 alcohol consumptions per week, plans to follow a weight reduction program with the aid of an energy restriction diet or a physical intervention program during the study period, participants diagnosed with any known chronic disease.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group is instructed to continue their habitual daily physical activity patterns and sedentary behaviour | |
| Experimental: CWAT intervention group<br>The CWAT group will receive the activity tracker. Subjects will receive inactivity alerts after 1 hour of inactivity to break up sitting time and avoid prolonged sitting. During the interruptions they will be asked to walk for several minutes. | Device: CWAT intervention<br>* Participant in the intervention group will wear an activity tracker for 12 weeks.<br>|
| Experimental: CWAT + motivation intervention group<br>Subjects randomised into the CWATLDP intervention will receive the activity tracker and will be stimulated with the aid of coaching sessions and goal setting. | Device: CWAT intervention<br>* Participant in the intervention group will wear an activity tracker for 12 weeks.<br>Device: CWAT + motivation intervention group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steps per day | Physical activity will be quantified using the activPAL3™ activity monitor. | Baseline | 
| sitting time | sedentary behaviour will be quantified using the activPAL3™ activity monitor. | baseline | 
| Steps per day | Physical activity will be quantified using the activPAL3™ activity monitor. | week 12 | 
| sitting time | sedentary behaviour will be quantified using the activPAL3™ activity monitor. | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg | baseline | 
| body weight | Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg | week 12 | 
| Height | Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot | baseline | 
| Height | Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot | week 12 | 
| DEXA (Dual Energy X-Ray) | body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry | baseline | 
| DEXA (Dual Energy X-Ray) | body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry | week 12 | 
| Concentration of glucose | Blood analysis | baseline | 
| Concentration of glucose | Blood analysis | week 12 | 
| Concentration of Insuline | Blood analysis | baseline | 
| Concentration of Insuline | Blood analysis | week 12 | 
| Concentration of total cholesterol | Blood analysis | baseline | 
| total cholesterol | Blood analysis | week 12 | 
| Concentration of high density lipoprotein cholesterol (HDL-cholesterol) | Blood analysis | baseline | 
| Concentration of high density lipoprotein cholesterol (HDL-cholesterol) | Blood analysis | week 12 | 
| Concentration of low density lipoprotein cholesterol (LDL-cholesterol) | Blood analysis | baseline | 
| Concentration of low density lipoprotein cholesterol (LDL-cholesterol) | Blood analysis | week 12 | 
| Concentration of triglyceride | Blood analysis | baseline | 
| Concentration of triglyceride | Blood analysis | week 12 | 
| Concentration of glycated haemoglobin (HbA1c) | Blood analysis | baseline | 
| Concentration of glycated haemoglobin (HbA1c) | Blood analysis | week 12 | 
| Concentration of uric acid | Blood analysis | baseline | 
| Concentration of uric acid | Blood analysis | week 12 | 
| Concentration of interleukin 6 (IL-6), | Blood analysis | baseline | 
| Concentration of interleukin 6 (IL-6), | Blood analysis | week 12 | 
| Concentration of tumor necrosis factor-alpha (TNF-α), | Blood analysis | baseline | 
| Concentration of tumor necrosis factor-alpha (TNF-α), | Blood analysis | week 12 | 
| Concentration of C-reactive protein (CRP) | Blood analysis | baseline | 
| Concentration of C-reactive protein (CRP) | Blood analysis | week 12 | 
| Concentration of serum amyloid A (SAA) | Blood analysis | baseline | 
| Concentration of serum amyloid A (SAA) | Blood analysis | week 12 | 
| Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), | Blood analysis | baseline | 
| Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), | Blood analysis | week 12 | 
| Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) | Blood analysis | baseline | 
| Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) | Blood analysis | week 12 | 
| Concentration of soluble E-selectin (sE-selectin). | Blood analysis | baseline | 
| Concentration of soluble E-selectin (sE-selectin). | Blood analysis | week 12 | 
| Vascular endothelial function | Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device | baseline | 
| Vascular endothelial function | Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | week 12 | 
| A six-minute walk test | The covered distance is measured during a six-minute walk test. | baseline | 
| A six-minute walk test | The covered distance is measured during a six-minute walk test. | week 12 | 
| Relative autonomy index | Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2). | baseline | 
| Relative autonomy index | Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2). | 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. | 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. | week 12 | 
| Macronutrient content | Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated. | baseline | 
| Macronutrient content | Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated. | week 12 |