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

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Fitness Trackers; Coronary Heart Disease; Genetic Predisposition to Disease; Sedentary Time

Treatments: Device: Genetic Risk Estimate + Fitbit Functions+Health Coaching; Genetic: Genetic Risk Estimate+Health Coaching

Study type: Interventional

Funder types: Other

Identifiers

NCT05789966

Fullscale_CHD_RCT

Details and patient eligibility

About

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).

Enrollment: 414 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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414 participants in 3 patient groups

Control Group

No Intervention group

Description:

The control group will receive a Fitbit device

Intervention Group - Genetic Risk Estimate+health coaching

Experimental group

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.

Treatment:

Device: Genetic Risk Estimate + Fitbit Functions+Health Coaching

Genetic: Genetic Risk Estimate+Health Coaching

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

Experimental group

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.

Treatment:

Device: Genetic Risk Estimate + Fitbit Functions+Health Coaching