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Fitness Trackers clinical trials

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NCT ID: NCT05789966 Not yet recruiting - Clinical trials for Coronary Heart Disease

Fullscale_Intervention Study: Genetic Risk Communication in Coronary Heart Disease and Wearables

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Background: This study aims to determine the effects of communicating genetic risk for Coronary Heart Disease (CHD) alone or in combination with goal setting and prompts from a wearable device on objectively measured sedentary time (ST) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively ST, and that such changes will be more likely to be sustained over 6-month follow-up. Methods: In a parallel group, randomized controlled trial, a total 414 individuals of East Asians aged over 60years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of CHD genetic and analysis of metabolic risk markers. Genetic risk for CHD will be estimated based on recently identified 79 SNPs (associated with CHD for East Asians) using an established methodology. Questionnaires and physical measurement will be administered at Before and after the 12-month intervention and at 6-month follow-up. Each group will receive a Fitbit device. Both intervention groups will be given CHD genetic risk estimates along with lifestyle advice but one of them will additionally use Fitbit's step-goal setting and prompt functions. The primary outcome is objectively measured sedentary time. Secondary outcomes include objectively measured MVPA, calories burned, and five intermediate metabolic risk markers (total cholesterol/HDL-C/LDL-C/triglycerides).

NCT ID: NCT05524909 Active, not recruiting - Type 2 Diabetes Clinical Trials

Full-scale Intervention Study: Genetic Risk Communication and Wearables

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Background: Communication of information about risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviors among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with changes in behavior in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects on wearable-device-measured PA of communicating genetic risk for T2D alone or in combination with goal setting and activity prompts from a wearable device among overweight or obese East Asians. Methods: In a parallel group, randomized controlled trial, a total of 355 overweight or obese East Asian individuals aged 40-60 years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 SNPs associated with T2D among East Asians using an established method. All three groups will receive a Fitbit device. Both intervention groups will be given T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will additionally use Fitbit's step-goal setting and prompt functions. Questionnaires and physical measurements will be administered at baseline, immediately after intervention delivery, and 6 and 12-month post-intervention following standard operating procedures. The primary outcome is time spent in moderate-to-vigorous PA measured through the Fitbit. Secondary outcomes include other parameters of wearable-device-measured PA, sedentary time, and sleep, body mass index, systolic and diastolic blood pressure, five intermediate metabolic risk markers, hand grip strength, self-reported PA, self-reported fruit and vegetable consumption and smoking status, and a list of psychological variables. Discussion: This study will be the first randomized controlled trial using the combination of communication of T2D genetic risk with standard functions of wearable devices in any population. Findings will inform strategies to prevent T2D through lifestyle modification.

NCT ID: NCT05418881 Recruiting - Surgery Clinical Trials

Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)

MONITOR
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.

NCT ID: NCT05234125 Recruiting - Pregnancy Related Clinical Trials

Better Lifestyle Counseling for African American Women During Pregnancy

BETTER
Start date: August 16, 2022
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.

NCT ID: NCT05077995 Completed - Fitness Trackers Clinical Trials

Validity and Reliability of the Polar M200 Activity Monitor

VAPO
Start date: July 25, 2021
Phase: N/A
Study type: Interventional

The aim of this study will be to investigate the validity of a consumer available activity tracker (Polar M200) in free-living conditions to measure sedentary time.

NCT ID: NCT05011279 Completed - Breast Cancer Clinical Trials

Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives)

Start date: September 10, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health.

NCT ID: NCT04879758 Recruiting - Type 2 Diabetes Clinical Trials

Intervention Study: Genetic Risk Communication and Wearables

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

This study aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively measured PA and SB, and that such changes will be more likely to be sustained over 6-month follow-up. This study aims to recruit 150 healthy East Asian adults in Hong Kong. At baseline, participants will be invited to visit the research laboratory for measurement of a series of variables including height, body weight, blood pressure and grip strength. Participants will also be invited to complete a set of questionnaires to assess their self-reported PA and SB, fruit and vegetable consumption, smoking status and psychological variables. Blood samples will be collected to analyze key diabetes and cardiovascular disease biochemical markers as well as their estimated genetic risk of T2D. Each individual's unique genetic risk for T2D will be estimated on the basis of established genetic variants associated with T2D specifically for East Asians. Each participant will be asked to wear a Fitbit Charge 4 tracker, an objective activity monitoring device, throughout the entire trial. Participants will be randomly allocated into 3 groups: 1 control and 2 intervention groups. A control group will receive an e-leaflet containing general lifestyle advice for prevention of T2D. An intervention group will receive an estimated genetic risk of T2D, in addition to the e-leaflet. The other intervention group will have a Fitbit step goal set 10% higher than their baseline step count and use prompt functions of the Fitbit tracker, in addition to the genetic risk estimate and e-leaflet. Activity data from the Fitbit will be collected at 4-week post-intervention; information about lifestyle and psychological variables will be assessed through the questionnaires at both immediate and 4-week post-intervention. To determine the longer-term effect of the intervention, participants will be asked to visit the research laboratory 6 months after the intervention to repeat the same set of assessments as baseline, except the blood samples collected at 6-month follow-up are used only to analyze cardiometabolic risk profiles (not genetic risk). Activity levels will also be objectively measured using the Fitbit for 4 weeks.

NCT ID: NCT04664101 Completed - Covid19 Clinical Trials

REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)

REMMHIIT-COVID
Start date: March 2, 2022
Phase: N/A
Study type: Interventional

REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)

NCT ID: NCT03175783 Recruiting - Surgery Clinical Trials

Use of Wearable Activity Tracker in Elderly Undergoing Abdominal Surgery

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Early mobilization is an important element in Enhanced Recovery After Surgery (ERAS). It reduces risk of conditions which are related to prolonged bed rest such as deep vein thrombosis, lung atelectasis, pneumonia, and sacral sore. (Appelboom, Taylor et al. 2015) It is also associated with shortened length of hospital stay, improved survival, and reduction in health care cost. However, "early mobilization" was not defined consistently in previous study. Some authors recommend patients to get out of bed and ambulate on the day of operation while others define as getting out of bed more than 2 hours on day of operation and up to 8 hours on second post-operative day. (Wolk, Meissner et al. 2017) The inconsistency in definition is partly due to the inability to quantify patients' mobility which is usually self-reported by patients and is subjective.(Eva van der Meij 2017) This is especially true for elderly patient in whom preoperative mobility varies significantly between individuals. For this reason, the approach of early mobilization in elderly should be goal directed and individualized according to their preoperative mobility and functional status. The aim of current study is to monitor and motivate elderly patients undergoing abdominal surgery to increase postoperative mobilization by using Fitbit Zip activity tracker.

NCT ID: NCT02888483 Completed - Exercise Clinical Trials

PEAKS: Validation of Mobile Technologies

PEAKS
Start date: July 2016
Phase:
Study type: Observational

The overall objective of this project is to evaluate and validate the accuracy and usability of a deployed beta sensor-based system. This is a cross-sectional validation study of 100 apparently health community dwelling adults aged 60+ years. Participants will perform standardized lifestyle, exercise and sedentary type physical activities in a clinic laboratory and home setting.