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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03853018
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Bert Op't Eijnde, Hasselt University

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

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Device: CWAT intervention Device: CWAT + motivation intervention group Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Steps per day [ Time Frame: Baseline ]
    Physical activity will be quantified using the activPAL3™ activity monitor.

  2. sitting time [ Time Frame: baseline ]
    sedentary behaviour will be quantified using the activPAL3™ activity monitor.

  3. Steps per day [ Time Frame: week 12 ]
    Physical activity will be quantified using the activPAL3™ activity monitor.

  4. sitting time [ Time Frame: week 12 ]
    sedentary behaviour will be quantified using the activPAL3™ activity monitor.


Secondary Outcome Measures :
  1. body weight [ Time Frame: baseline ]
    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  2. body weight [ Time Frame: week 12 ]
    Body weight (in underwear) is determined using a digital-balanced weighting scale to the nearest 0.1kg

  3. Height [ Time Frame: baseline ]
    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot

  4. Height [ Time Frame: week 12 ]
    Body height is measured to the nearest 0.1cm using a wall-mounted Harpenden stadiometer, with participants barefoot

  5. DEXA (Dual Energy X-Ray) [ Time Frame: baseline ]
    body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry

  6. DEXA (Dual Energy X-Ray) [ Time Frame: week 12 ]
    body fat mass and lean tissue mass using Dual Energy X-ray Absorptiometry

  7. Concentration of glucose [ Time Frame: baseline ]
    Blood analysis

  8. Concentration of glucose [ Time Frame: week 12 ]
    Blood analysis

  9. Concentration of Insuline [ Time Frame: baseline ]
    Blood analysis

  10. Concentration of Insuline [ Time Frame: week 12 ]
    Blood analysis

  11. Concentration of total cholesterol [ Time Frame: baseline ]
    Blood analysis

  12. total cholesterol [ Time Frame: week 12 ]
    Blood analysis

  13. Concentration of high density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: baseline ]
    Blood analysis

  14. Concentration of high density lipoprotein cholesterol (HDL-cholesterol) [ Time Frame: week 12 ]
    Blood analysis

  15. Concentration of low density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: baseline ]
    Blood analysis

  16. Concentration of low density lipoprotein cholesterol (LDL-cholesterol) [ Time Frame: week 12 ]
    Blood analysis

  17. Concentration of triglyceride [ Time Frame: baseline ]
    Blood analysis

  18. Concentration of triglyceride [ Time Frame: week 12 ]
    Blood analysis

  19. Concentration of glycated haemoglobin (HbA1c) [ Time Frame: baseline ]
    Blood analysis

  20. Concentration of glycated haemoglobin (HbA1c) [ Time Frame: week 12 ]
    Blood analysis

  21. Concentration of uric acid [ Time Frame: baseline ]
    Blood analysis

  22. Concentration of uric acid [ Time Frame: week 12 ]
    Blood analysis

  23. Concentration of interleukin 6 (IL-6), [ Time Frame: baseline ]
    Blood analysis

  24. Concentration of interleukin 6 (IL-6), [ Time Frame: week 12 ]
    Blood analysis

  25. Concentration of tumor necrosis factor-alpha (TNF-α), [ Time Frame: baseline ]
    Blood analysis

  26. Concentration of tumor necrosis factor-alpha (TNF-α), [ Time Frame: week 12 ]
    Blood analysis

  27. Concentration of C-reactive protein (CRP) [ Time Frame: baseline ]
    Blood analysis

  28. Concentration of C-reactive protein (CRP) [ Time Frame: week 12 ]
    Blood analysis

  29. Concentration of serum amyloid A (SAA) [ Time Frame: baseline ]
    Blood analysis

  30. Concentration of serum amyloid A (SAA) [ Time Frame: week 12 ]
    Blood analysis

  31. Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), [ Time Frame: baseline ]
    Blood analysis

  32. Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1), [ Time Frame: week 12 ]
    Blood analysis

  33. Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) [ Time Frame: baseline ]
    Blood analysis

  34. Concentration of soluble intercellular adhesion molecule 1 (sICAM-1) [ Time Frame: week 12 ]
    Blood analysis

  35. Concentration of soluble E-selectin (sE-selectin). [ Time Frame: baseline ]
    Blood analysis

  36. Concentration of soluble E-selectin (sE-selectin). [ Time Frame: week 12 ]
    Blood analysis

  37. Vascular endothelial function [ Time Frame: baseline ]
    Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device

  38. Vascular endothelial function [ Time Frame: week 12 ]
    Endothelial function will be assessed by non-invasive peripheral arterial tonometry using the EndoPAT™ 2000 device

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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.

  70. 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.

  71. A six-minute walk test [ Time Frame: baseline ]
    The covered distance is measured during a six-minute walk test.

  72. A six-minute walk test [ Time Frame: week 12 ]
    The covered distance is measured during a six-minute walk test.

  73. Relative autonomy index [ Time Frame: baseline ]
    Individual motives for physical activity are assessed using the Behavioural Regulation and Exercise Questionnaire version 2 (BREQ-2).

  74. 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).

  75. 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.

  76. 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.

  77. 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.

  78. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853018


Contacts
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Contact: Bert Op 't Eijnde, prof.dr. +32 11 29 21 21 bert.opteijnde@uhasselt.be
Contact: Wouter Franssen, drs. +32 11 29 21 29 wouter.franssen@uhasselt.be

Locations
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Belgium
Hasselt University Recruiting
Diepenbeek, Limburg, Belgium, 3590
Contact: Wouter Franssen, MSc    +3211292129    wouter.franssen@uhasselt.be   
Contact: Bert Op 't Eijnde, Prof.    +3211292121    bert.opteijnde@uhasselt.be   
Sponsors and Collaborators
Hasselt University
Investigators
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Study Chair: Bert Op 't Eijnde, prof. dr. Hasselt University
Principal Investigator: Wouter Franssen, drs. Hasselt University

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Responsible Party: Bert Op't Eijnde, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03853018     History of Changes
Other Study ID Numbers: CWATLDP-001
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No