Clinical trial NCT03853018: Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults
Official title: The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Steps per day
timeFrame: Baseline
measure: sitting time
timeFrame: baseline
measure: Steps per day
timeFrame: week 12
measure: sitting time
timeFrame: week 12
Secondary outcomes:
measure: body weight
timeFrame: baseline
measure: body weight
timeFrame: week 12
measure: Height
timeFrame: baseline
measure: Height
timeFrame: week 12
measure: DEXA (Dual Energy X-Ray)
timeFrame: baseline
measure: DEXA (Dual Energy X-Ray)
timeFrame: week 12
measure: Concentration of glucose
timeFrame: baseline
measure: Concentration of glucose
timeFrame: week 12
measure: Concentration of Insuline
timeFrame: baseline
measure: Concentration of Insuline
timeFrame: week 12
measure: Concentration of total cholesterol
timeFrame: baseline
measure: total cholesterol
timeFrame: week 12
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: baseline
measure: Concentration of high density lipoprotein cholesterol (HDL-cholesterol)
timeFrame: week 12
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: baseline
measure: Concentration of low density lipoprotein cholesterol (LDL-cholesterol)
timeFrame: week 12
measure: Concentration of triglyceride
timeFrame: baseline
measure: Concentration of triglyceride
timeFrame: week 12
measure: Concentration of glycated haemoglobin (HbA1c)
timeFrame: baseline
measure: Concentration of glycated haemoglobin (HbA1c)
timeFrame: week 12
measure: Concentration of uric acid
timeFrame: baseline
measure: Concentration of uric acid
timeFrame: week 12
measure: Concentration of interleukin 6 (IL-6),
timeFrame: baseline
measure: Concentration of interleukin 6 (IL-6),
timeFrame: week 12
measure: Concentration of tumor necrosis factor-alpha (TNF-α),
timeFrame: baseline
measure: Concentration of tumor necrosis factor-alpha (TNF-α),
timeFrame: week 12
measure: Concentration of C-reactive protein (CRP)
timeFrame: baseline
measure: Concentration of C-reactive protein (CRP)
timeFrame: week 12
measure: Concentration of serum amyloid A (SAA)
timeFrame: baseline
measure: Concentration of serum amyloid A (SAA)
timeFrame: week 12
measure: Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
timeFrame: baseline
measure: Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),
timeFrame: week 12
measure: Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
timeFrame: baseline
measure: Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)
timeFrame: week 12
measure: Concentration of soluble E-selectin (sE-selectin).
timeFrame: baseline
measure: Concentration of soluble E-selectin (sE-selectin).
timeFrame: week 12
measure: Vascular endothelial function
timeFrame: baseline
measure: Vascular endothelial function
timeFrame: week 12
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: baseline
measure: Homeostatic model assessment for insulin resistance (HOMA-IR)
timeFrame: week 12
measure: Whole-body insulin sensitivity index (ISI)
timeFrame: baseline
measure: Whole-body insulin sensitivity index (ISI)
timeFrame: week 12
measure: Area under the curve of insulin concentrations
timeFrame: baseline
measure: Area under the curve of insulin concentrations
timeFrame: week 12
measure: Area under the curve of glucose concentrations
timeFrame: baseline
measure: Area under the curve of glucose concentrations
timeFrame: week 12
measure: Insulinogenic index
timeFrame: baseline
measure: Insulinogenic index
timeFrame: week 12
measure: Cardiac autonomic function
timeFrame: baseline
measure: Cardiac autonomic function
timeFrame: week 12
measure: Systolic and Diastolic Blood pressure
timeFrame: baseline
measure: Systolic and Diastolic Blood pressure
timeFrame: week 12
measure: Oxygen uptake (VO2)
timeFrame: baseline
measure: Oxygen uptake (VO2)
timeFrame: week 12
measure: Carbon dioxide output (VCO2)
timeFrame: baseline
measure: Carbon dioxide output (VCO2)
timeFrame: week 12
measure: Minute ventilation (VE)
timeFrame: baseline
measure: Minute ventilation (VE)
timeFrame: week 12
measure: Equivalents for oxygen uptake (VE/VO2)
timeFrame: baseline
measure: Equivalents for oxygen uptake (VE/VO2)
timeFrame: week 12
measure: Equivalents for carbon dioxide production (VE/VCO2)
timeFrame: baseline
measure: Equivalents for carbon dioxide production (VE/VCO2)
timeFrame: week 12
measure: Tidal volume (Vt)
timeFrame: baseline
measure: Tidal volume (Vt)
timeFrame: week 12
measure: Breathing frequency (BF)
timeFrame: baseline
measure: Breathing frequency (BF)
timeFrame: week 12
measure: Respiratory gas exchange ratio (RER)
timeFrame: baseline
measure: Respiratory gas exchange ratio (RER)
timeFrame: week 12
measure: Heart rate (HR)
timeFrame: baseline
measure: Heart rate (HR)
timeFrame: week 12
measure: A six-minute walk test
timeFrame: baseline
measure: A six-minute walk test
timeFrame: week 12
measure: Relative autonomy index
timeFrame: baseline
measure: Relative autonomy index
timeFrame: week 12
measure: Total calorie intake
timeFrame: baseline
measure: Total calorie intake
timeFrame: week 12
measure: Macronutrient content
timeFrame: baseline
measure: Macronutrient content
timeFrame: week 12
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Bert Op 't Eijnde, prof. dr.
role: STUDY_CHAIR
affiliation: Hasselt University
name: Wouter Franssen, drs.
role: PRINCIPAL_INVESTIGATOR
References: