RecruitingNot ApplicableNCT07119658

Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial

Sponsor

Indiana University

Enrollment

20 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolic Syndrome Hypertension Diabetes Hyperglycemia Hyperlipidemia Dyslipidemia Obesity &Amp; Overweight Emergency Medicine

Summary

The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether the emergency department (ED) can be used as a starting point to connect people with metabolic syndrome to longer-term care. Metabolic syndrome is a cluster of health conditions — including obesity, high blood pressure, high blood sugar, and abnormal cholesterol — that raise the risk of heart disease and diabetes. The study targets people who come to the ED but are well enough to go home. **You may be eligible if...** - You are 18 or older and visiting the emergency department - You have a BMI of 30 or above (obesity) - You have been previously diagnosed with at least one other metabolic syndrome component: high blood pressure, high blood sugar, or abnormal cholesterol - You are being discharged home (not admitted to hospital) - You own or have access to a smartphone **You may NOT be eligible if...** - You are under 18 or pregnant - You cannot safely walk - You do not have access to a smartphone or are unwilling to wear a monitoring device - You are being admitted to the hospital Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALComposite intervention to address MetS

The composite intervention includes six components: 1. All patients will be provided a Fitbit Charge device at ED discharge with instructions to wear on their wrist for study duration. 2. Participants in the intervention group will first watch a brief (\~5 minute) educational video outlining the adverse effects of MetS and the benefit of walking, via iPad tablet. 3. Participants in the intervention group will also be given accompanying written "exercise prescription" encouraging them to walk 150 minutes per week. 4. Reminder texts encouraging continued walking behavior (i.e. "Remember to get in your steps!") will be sent to the intervention group, at approximate 2-3x/week intervals for the 3-month follow-up period. 5. The intervention group will also be provided written resources for healthy eating practices upon ED discharge. 6. All intervention group participants will receive referrals into primary care clinic and the Eskenazi Health "Healthy Me" Program for follow-up.