search
Back to results

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

Primary Purpose

Fitness Trackers, Sedentary Time, Genetic Predisposition to Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Genetic Risk Estimate+Health Coaching
Genetic Risk Estimate + Fitbit Functions+Health Coaching
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fitness Trackers focused on measuring Coronary Heart Disease, Genetic risk, Sedentary Time, Wearable Technology, Randomized Controlled Trial

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: East Asian ancestry Do not meet the WHO-recommended levels of PA (i.e., ≥150 minutes/week of moderate-intensity PA, ≥75 minutes/week of vigorous-intensity PA, or an equivalent combination of the two; determined through the IPAQ-Short Form). Exclusion Criteria: Previously diagnosed with CHD, and/or participation in another exercise-intervention study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control Group

    Intervention Group - Genetic Risk Estimate+health coaching

    Intervention Group - Genetic Risk Estimate + Fitbit Functions+health coaching

    Arm Description

    The control group will receive a Fitbit device

    Genetic: Genetic Risk Estimate The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk). Health coaching will be incorporated as well.

    Device: Genetic Risk Estimate + Fitbit Functions The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' or 'no increased genetic risk'. The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate. Health coaching will be incorporated as well.

    Outcomes

    Primary Outcome Measures

    Changes in ST (average, in minutes/day) between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    ST (average, in minutes/day) will be objectively measured by the Fitbit tracker.

    Secondary Outcome Measures

    Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)
    steps, sedentary minutes, lightly active minutes, calories burn, and sleep time will be objectively measured by the Fitbit tracker.
    Changes in four CHD markers (total cholesterol/HDL-C/LDL-C/triglycerides) between baseline and 6-month follow-up
    Blood samples will be collected to test the four key markers for CHD
    Changes in hand grip strength between baseline and 6-month follow-up
    Hand grip strength (in kilograms) will be measured using the Jamar Hydraulic Hand Dynamometer, which has good reliability and reproducibility.
    Changes in systolic/diastolic blood pressure between baseline and 6-month follow-up
    Systolic/diastolic blood pressure will be measured using a digital automatic sphygmomanometer
    Changes in Self-reported Physical Activity between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    This outcome will be assessed using an assessment questionnaire.
    Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    This outcome will be assessed using an assessment questionnaire.
    Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    This outcome will be assessed using an assessment questionnaire.
    Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    This outcome will be assessed using an assessment questionnaire.

    Full Information

    First Posted
    March 16, 2023
    Last Updated
    March 16, 2023
    Sponsor
    The University of Hong Kong
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05789966
    Brief Title
    Fullscale_Intervention Study: Genetic Risk Communication in Coronary Heart Disease and Wearables
    Official Title
    The Effect of Communicating Genetic Risk of Coronary Heart Disease and Wearable Technologies On Wearable-Device-Measured Behavioral Outcomes in East Asians: Protocol of a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2026 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fitness Trackers, Sedentary Time, Genetic Predisposition to Disease, Coronary Heart Disease
    Keywords
    Coronary Heart Disease, Genetic risk, Sedentary Time, Wearable Technology, Randomized Controlled Trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    parallel-group, open randomized controlled trial
    Masking
    ParticipantInvestigator
    Masking Description
    Staff without knowledge of participant information will create a computer-generated list that consists of blocks of six that contain two of each of the three groups per block in a random order. The randomisation list will be incorporated into a computer program that our staff will use for enrolment and automated random assignment of participants. Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (to allow preparation of genetic risk estimates and/or calculate Fitbit step goals from baseline data) and concealed from participants until the intervention begins. Given the nature of the interventions, it is impossible for participants to be blinded to their group allocation; however, research staff analysing participants' deidentified data will remain blinded to participant group assignments.
    Allocation
    Randomized
    Enrollment
    414 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    The control group will receive a Fitbit device
    Arm Title
    Intervention Group - Genetic Risk Estimate+health coaching
    Arm Type
    Experimental
    Arm Description
    Genetic: Genetic Risk Estimate The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk). Health coaching will be incorporated as well.
    Arm Title
    Intervention Group - Genetic Risk Estimate + Fitbit Functions+health coaching
    Arm Type
    Experimental
    Arm Description
    Device: Genetic Risk Estimate + Fitbit Functions The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' or 'no increased genetic risk'. The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate. Health coaching will be incorporated as well.
    Intervention Type
    Genetic
    Intervention Name(s)
    Genetic Risk Estimate+Health Coaching
    Intervention Description
    The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk). Health coaching will be incorporated through phone or Zoom calls to provide an explanation of each participant's own genetic risk of CHD as well as lifestyle modification measures.
    Intervention Type
    Device
    Intervention Name(s)
    Genetic Risk Estimate + Fitbit Functions+Health Coaching
    Intervention Description
    Intervention: Device: Genetic Risk Estimate + Fitbit Functions The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' or 'no increased genetic risk'. The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate. Health coaching will be incorporated as well
    Primary Outcome Measure Information:
    Title
    Changes in ST (average, in minutes/day) between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    Description
    ST (average, in minutes/day) will be objectively measured by the Fitbit tracker.
    Time Frame
    Baseline, 12-month post-intervention, 6-month follow-up
    Secondary Outcome Measure Information:
    Title
    Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)
    Description
    steps, sedentary minutes, lightly active minutes, calories burn, and sleep time will be objectively measured by the Fitbit tracker.
    Time Frame
    Baseline, 12-month post-intervention, 6-month follow-up
    Title
    Changes in four CHD markers (total cholesterol/HDL-C/LDL-C/triglycerides) between baseline and 6-month follow-up
    Description
    Blood samples will be collected to test the four key markers for CHD
    Time Frame
    Baseline and 6-month follow-up
    Title
    Changes in hand grip strength between baseline and 6-month follow-up
    Description
    Hand grip strength (in kilograms) will be measured using the Jamar Hydraulic Hand Dynamometer, which has good reliability and reproducibility.
    Time Frame
    Baseline and 6-month follow-up
    Title
    Changes in systolic/diastolic blood pressure between baseline and 6-month follow-up
    Description
    Systolic/diastolic blood pressure will be measured using a digital automatic sphygmomanometer
    Time Frame
    Baseline and 6-month follow-up
    Title
    Changes in Self-reported Physical Activity between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    Description
    This outcome will be assessed using an assessment questionnaire.
    Time Frame
    Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
    Title
    Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    Description
    This outcome will be assessed using an assessment questionnaire.
    Time Frame
    Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
    Title
    Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    Description
    This outcome will be assessed using an assessment questionnaire.
    Time Frame
    Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
    Title
    Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
    Description
    This outcome will be assessed using an assessment questionnaire.
    Time Frame
    Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: East Asian ancestry Do not meet the WHO-recommended levels of PA (i.e., ≥150 minutes/week of moderate-intensity PA, ≥75 minutes/week of vigorous-intensity PA, or an equivalent combination of the two; determined through the IPAQ-Short Form). Exclusion Criteria: Previously diagnosed with CHD, and/or participation in another exercise-intervention study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Youngwon Kim, Dr
    Phone
    (+852)28315252
    Email
    youngwon.kim@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Youngwon Kim, Dr
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs