Clinical trial NCT05789966: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fitness Trackers
Sedentary Time
Genetic Predisposition to Disease
Coronary Heart Disease
Keywords: Coronary Heart Disease
Genetic risk
Sedentary Time
Wearable Technology
Randomized Controlled Trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 414
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group, open randomized controlled trial
Primary purpose: PREVENTION

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).


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.

Primary outcomes:
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
timeFrame: Baseline, 12-month post-intervention, 6-month follow-up
Secondary outcomes:
measure: Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)
timeFrame: Baseline, 12-month post-intervention, 6-month follow-up
measure: Changes in four CHD markers (total cholesterol/HDL-C/LDL-C/triglycerides) between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in hand grip strength between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in systolic/diastolic blood pressure between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Other outcomes:
Locations:
Study officials:
affiliation: The University of Hong Kong
name: Youngwon Kim, Dr
role: PRINCIPAL_INVESTIGATOR
References: