Sedentary Lifestyle
Conditions
Brief summary
This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health.
Detailed description
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.
Interventions
DEVICECWAT intervention
Participant in the intervention group will wear an activity tracker for 12 weeks.
DEVICECWAT + motivation intervention group
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.
Sponsors
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps per day | Baseline | Physical activity will be quantified using the activPAL3™ activity monitor. |
| sitting time | baseline | sedentary behaviour will be quantified using the activPAL3™ activity monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of interleukin 6 (IL-6), | baseline | Blood analysis |
| Concentration of serum amyloid A (SAA) | baseline | Blood analysis |
| Concentration of tumor necrosis factor-alpha (TNF-α), | baseline | Blood analysis |
| Concentration of C-reactive protein (CRP) | baseline | Blood analysis |
| body weight | baseline | Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg |
| Height | baseline | Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot |
| DEXA (Dual Energy X-Ray) | baseline | body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry |
| Concentration of glucose | baseline | Blood analysis |
| Concentration of Insuline | baseline | Blood analysis |
| Concentration of total cholesterol | baseline | Blood analysis |
| total cholesterol | week 12 | Blood analysis |
| Concentration of high density lipoprotein cholesterol (HDL-cholesterol) | baseline | Blood analysis |
| Concentration of low density lipoprotein cholesterol (LDL-cholesterol) | baseline | Blood analysis |
| Concentration of triglyceride | baseline | Blood analysis |
| Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), | baseline | Blood analysis |
| Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) | baseline | Blood analysis |
| Concentration of soluble E-selectin (sE-selectin). | baseline | Blood analysis |
| Vascular endothelial function | baseline | Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device |
| Homeostatic model assessment for insulin resistance (HOMA-IR) | baseline | 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. |
| Whole-body insulin sensitivity index (ISI) | baseline | 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. |
| Area under the curve of insulin concentrations | baseline | 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. |
| Area under the curve of glucose concentrations | baseline | 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. |
| Insulinogenic index | baseline | 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. |
| Cardiac autonomic function | baseline | 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 |
| Systolic and Diastolic Blood pressure | baseline | Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer |
| Oxygen uptake (VO2) | baseline | 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. |
| Carbon dioxide output (VCO2) | baseline | 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. |
| Minute ventilation (VE) | baseline | 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. |
| Equivalents for oxygen uptake (VE/VO2) | baseline | 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. |
| Equivalents for carbon dioxide production (VE/VCO2) | baseline | 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. |
| Tidal volume (Vt) | baseline | 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. |
| Breathing frequency (BF) | baseline | 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. |
| Respiratory gas exchange ratio (RER) | baseline | 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. |
| Heart rate (HR) | baseline | 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. |
| Concentration of glycated haemoglobin (HbA1c) | baseline | Blood analysis |
| Relative autonomy index | baseline | Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2). |
| Total calorie intake | baseline | Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated. |
| Macronutrient content | baseline | Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated. |
| A six-minute walk test | baseline | The covered distance is measured during a six-minute walk test. |
| Concentration of uric acid | baseline | Blood analysis |
Countries
Belgium
Outcome results
None listed