2.4. Phase 3: Randomized Controlled Trial
obesity, PAD, stroke, cancer, CAD, diabetes, cancer, arrhythmias, diabetes
OBESITY, RECRUITMENT, ELEVATED CHOLESTEROL, STROKE, ATHEROSCLEROSIS, EVENTS, CANCER, PAD, METABOLIC SYNDROME, INSULIN RESISTANCE, DIABETES, HEART ATTACK, ARRHYTHMIAS, HEART FAILURE, HYPERTENSION, TYPE 2 DIABETES, CAD, DYSLIPIDEMIA
Recruitment. A total sample of 100 participants (50 each in the control and intervention arms) were recruited over a period of 18 months during the heights of the COVID-19 pandemic. We recruited participants from Research Match, social media platforms (Facebook, Twitter, Instagram, LinkedIn), email outreach via community connections, patient registries, and community organizations. Initial phone screenings gauged eligibility criteria, which included age (18+), English proficiency, smartphone ownership, app download willingness, and a self-reported history of cardiometabolic risk factors. Cardiometabolic risk factors included the following: hypertension, CAD, heart attack, heart failure, stroke, atherosclerosis, arrhythmias, PAD, type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol. Eligible participants received an email link for informed consent and baseline surveys through REDCAP. Afterward, randomization placed them in either the personalized intervention or standard control group. To support participant retention, regular phone and email interactions were maintained with less-engaged participants. Intervention and controlled arms. In the intervention arm, participants experienced a multifaceted approach: they were exposed to a tailored newsfeed containing insights, advice, and solutions related to chronic health conditions such as hypertension, diabetes, cancer, and obesity. This feed also provided information about health events and clinical trials through an Eventbrite API linked with our mobile application featuring AI-curated content from the web on cancer, diabetes, obesity, and hypertension. A notable feature of our app was its integration with Fitbit or Apple Watch, motivating participants to monitor their sleep and physical activity for enhanced daily well-being. This engagement strategy ensured sustained interest in health-related content, clinical trial opportunities, and educational activities. Participants further received personalized SMS push notifications guiding them to track physical activity levels throughout the project duration. A resident physician was available to address medical queries from participants concerning their health status within the context of the study. In the control arm, participants received a standard paper-based treatment and did not have access to the personalized newsfeed or mobile application features described above. At follow-up assessments, adherence to physical activity and sleep was collected using self-reported diaries. Weekly ecological momentary assessments through mobile device messages gauged attitudes towards clinical trials over four weeks. Baseline demographic data was collected, and quantitative measures were administered at the four-week follow-up (see In accordance with best practices for conducting and reporting randomized controlled trials (RCTs), we diligently adhered to the Consolidated Standards of Reporting Trials (CONSORT) guidelines tailored to our study, PREDHiCT. CONSORT, developed to facilitate clear, transparent, and comprehensive reporting of RCTs, comprises a 25-item checklist. Our adherence to the CONSORT checklist ensured meticulous attention to detail in reporting various aspects of our trial design, 