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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05789966
• Lead Sponsor: The University of Hong Kong

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Last Update Submitted: 2023-03-16
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29
• Study Start: 2024-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 414

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	Baseline, 12-month post-intervention, 6-month follow-up	ST (average, in minutes/day) will be objectively measured by the Fitbit tracker.

Secondary Outcome Measures

Name	Time	Method
Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)	Baseline, 12-month post-intervention, 6-month follow-up	steps, sedentary minutes, lightly active minutes, calories burn, and sleep time will be objectively measured by the Fitbit tracker.
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	Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up	This outcome will be assessed using an assessment questionnaire.
Changes in four CHD markers (total cholesterol/HDL-C/LDL-C/triglycerides) between baseline and 6-month follow-up	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	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	Baseline and 6-month follow-up	Systolic/diastolic blood pressure will be measured using a digital automatic sphygmomanometer
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	Baseline, Immediate post-intervention, 12-month post-intervention, 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	Baseline, Immediate post-intervention, 12-month post-intervention, 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	Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up	This outcome will be assessed using an assessment questionnaire.