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Fitness TrackersNCT05789966

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

A study testing Genetic Risk Estimate+Health Coaching and Genetic Risk Estimate + Fitbit Functions+Health Coaching in people with Fitness Trackers and Sedentary Time, run by The University of Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Genetic Risk Estimate+Health Coaching and Genetic Risk Estimate + Fitbit Functions+Health Coaching
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
No sites listed yet
Study dates
1 Jan 2024to 1 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Previously diagnosed with CHD, and/or participation in another exercise-intervention study.

Trial locations and contacts

No sites are listed yet.

Youngwon Kim, Dr contact

(+852)28315252

youngwon.kim@hku.hk

About this study

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

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).

Being tested
Genetic Risk Estimate+Health Coaching, Genetic Risk Estimate + Fitbit Functions+Health Coaching
Keywords
Coronary Heart Disease, Genetic risk, Sedentary Time, Wearable Technology, Randomized Controlled Trial
Medical subject headings
Sedentary Behavior, Genetic Predisposition to Disease, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic Risk Estimate+Health CoachingGenetic

    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.

  • Genetic Risk Estimate + Fitbit Functions+Health CoachingDevice

    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

Study groups in NCT05789966
Study groupRoleWhat they receive
Control GroupNo interventionThe control group will receive a Fitbit device
Intervention Group - Genetic Risk Estimate+health coachingExperimentalGenetic: 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.
Receives: Genetic: Genetic Risk Estimate+Health Coaching; Device: Genetic Risk Estimate + Fitbit Functions+Health Coaching
Intervention Group - Genetic Risk Estimate + Fitbit Functions+health coachingExperimentalDevice: 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.
Receives: Device: Genetic Risk Estimate + Fitbit Functions+Health Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 12-month post-intervention, 6-month follow-up

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 12-month post-intervention, 6-month follow-up

  2. 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

    Measured: Baseline and 6-month follow-up

  3. 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.

    Measured: Baseline and 6-month follow-up

  4. 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

    Measured: Baseline and 6-month follow-up

  5. 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.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  6. 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.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  7. 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.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  8. 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.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel-group, open randomized controlled trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
414 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05789966
Sponsor's protocol ID
Fullscale_CHD_RCT
Status last verified
Mar 2023
First submitted
16 Mar 2023
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Genetic Risk Estimate+Health Coaching and Genetic Risk Estimate + Fitbit Functions+Health Coaching in people with Fitness Trackers and Sedentary Time, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Youngwon Kim, Dr ((+852)28315252, youngwon.kim@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, 12-month post-intervention, 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05789966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

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