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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03853018
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Bert Op't Eijnde, Hasselt University

Tracking Information
First Submitted Date  ICMJE November 15, 2018
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date June 10, 2021
Actual Study Start Date  ICMJE November 15, 2018
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Steps per day [ Time Frame: Baseline ]
    Physical activity will be quantified using the activPAL3™ activity monitor.
  • sitting time [ Time Frame: baseline ]
    sedentary behaviour will be quantified using the activPAL3™ activity monitor.
  • Steps per day [ Time Frame: week 12 ]
    Physical activity will be quantified using the activPAL3™ activity monitor.
  • sitting time [ Time Frame: week 12 ]
    sedentary behaviour will be quantified using the activPAL3™ activity monitor.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • body weight [ Time Frame: baseline ]
    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
  • body weight [ Time Frame: week 12 ]
    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg
  • Height [ Time Frame: baseline ]
    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
  • Height [ Time Frame: week 12 ]
    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot
  • DEXA (Dual Energy X-Ray) [ Time Frame: baseline ]
    body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
  • DEXA (Dual Energy X-Ray) [ Time Frame: week 12 ]
    body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry
  • Concentration of glucose [ Time Frame: baseline ]
    Blood analysis
  • Concentration of glucose [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of Insuline [ Time Frame: baseline ]
    Blood analysis
  • Concentration of Insuline [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of total cholesterol [ Time Frame: baseline ]
    Blood analysis
  • total cholesterol [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: baseline ]
    Blood analysis
  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: baseline ]
    Blood analysis
  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of triglyceride [ Time Frame: baseline ]
    Blood analysis
  • Concentration of triglyceride [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of glycated haemoglobin (HbA1c) [ Time Frame: baseline ]
    Blood analysis
  • Concentration of glycated haemoglobin (HbA1c) [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of uric acid [ Time Frame: baseline ]
    Blood analysis
  • Concentration of uric acid [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of interleukin 6 (IL-6), [ Time Frame: baseline ]
    Blood analysis
  • Concentration of interleukin 6 (IL-6), [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of tumor necrosis factor-alpha (TNF-α), [ Time Frame: baseline ]
    Blood analysis
  • Concentration of tumor necrosis factor-alpha (TNF-α), [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of C-reactive protein (CRP) [ Time Frame: baseline ]
    Blood analysis
  • Concentration of C-reactive protein (CRP) [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of serum amyloid A (SAA) [ Time Frame: baseline ]
    Blood analysis
  • Concentration of serum amyloid A (SAA) [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), [ Time Frame: baseline ]
    Blood analysis
  • Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) [ Time Frame: baseline ]
    Blood analysis
  • Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) [ Time Frame: week 12 ]
    Blood analysis
  • Concentration of soluble E-selectin (sE-selectin). [ Time Frame: baseline ]
    Blood analysis
  • Concentration of soluble E-selectin (sE-selectin). [ Time Frame: week 12 ]
    Blood analysis
  • Vascular endothelial function [ Time Frame: baseline ]
    Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device
  • Vascular endothelial function [ Time Frame: week 12 ]
    Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device
  • Homeostatic model assessment for insulin resistance (HOMA-IR) [ Time Frame: 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.
  • Homeostatic model assessment for insulin resistance (HOMA-IR) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Whole-body insulin sensitivity index (ISI) [ Time Frame: week 12 ]
    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 [ Time Frame: 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 insulin concentrations [ Time Frame: week 12 ]
    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 [ Time Frame: 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.
  • Area under the curve of glucose concentrations [ Time Frame: week 12 ]
    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 [ Time Frame: 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.
  • Insulinogenic index [ Time Frame: week 12 ]
    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 [ Time Frame: 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
  • Cardiac autonomic function [ Time Frame: week 12 ]
    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 [ Time Frame: baseline ]
    Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
  • Systolic and Diastolic Blood pressure [ Time Frame: week 12 ]
    Systolic, diastolic and mean arterial blood pressure will be measured 3 times at 5-min intervals using an electronic sphygmomanometer
  • Oxygen uptake (VO2) [ Time Frame: 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.
  • Oxygen uptake (VO2) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Carbon dioxide output (VCO2) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Minute ventilation (VE) [ Time Frame: week 12 ]
    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) [ Time Frame: 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 oxygen uptake (VE/VO2) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Equivalents for carbon dioxide production (VE/VCO2) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Tidal volume (Vt) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Breathing frequency (BF) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Respiratory gas exchange ratio (RER) [ Time Frame: week 12 ]
    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) [ Time Frame: 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.
  • Heart rate (HR) [ Time Frame: week 12 ]
    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.
  • A six-minute walk test [ Time Frame: baseline ]
    The covered distance is measured during a six-minute walk test.
  • A six-minute walk test [ Time Frame: week 12 ]
    The covered distance is measured during a six-minute walk test.
  • Relative autonomy index [ Time Frame: baseline ]
    Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).
  • Relative autonomy index [ Time Frame: week 12 ]
    Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).
  • Total calorie intake [ Time Frame: baseline ]
    Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
  • Total calorie intake [ Time Frame: week 12 ]
    Participants will record all food and beverages consumed over seven consecutive days and from this the total calorie intake is calculated.
  • Macronutrient content [ Time Frame: baseline ]
    Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
  • Macronutrient content [ Time Frame: week 12 ]
    Participants will record all food and beverages consumed over seven consecutive days and from this the macronutrient content is calculated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Activity Trackers to Reduce Sedentary Behaviour in Sedentary Adults
Official Title  ICMJE The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Sedentary Lifestyle
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: CWAT intervention
  • 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.
    Interventions:
    • Device: CWAT intervention
    • Device: CWAT + motivation intervention group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2021)
60
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2019)
90
Actual Study Completion Date  ICMJE February 1, 2021
Actual Primary Completion Date February 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03853018
Other Study ID Numbers  ICMJE CWATLDP-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bert Op't Eijnde, Hasselt University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hasselt University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bert Op 't Eijnde, prof. dr. Hasselt University
Principal Investigator: Wouter Franssen, drs. Hasselt University
PRS Account Hasselt University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP