Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults (CWATLDP)

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

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

Study Overview

• Status: Completed
• Conditions: Sedentary Lifestyle
• Intervention / Treatment: Device: CWAT intervention; Device: CWAT + motivation intervention group

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Diepenbeek, Limburg, Belgium, 3590
      • Hasselt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group is instructed to continue their habitual daily physical activity patterns and sedentary behaviour
Experimental: CWAT intervention group; 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; Participant in the intervention group will wear an activity tracker for 12 weeks.
Experimental: CWAT + motivation intervention group; 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; Participant in the intervention group will wear an activity tracker for 12 weeks.; Device: CWAT + 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Wouter Franssen, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2018
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CWATLDP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No