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

Not Applicable

Recruiting

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

• Registration Number: NCT07119658
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-08
• Study First Submitted: 2025-07-29
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-06
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Ambulatory adults (18 years of age) presenting to the emergency department setting
• BMI 30 kg/m2
• Prior diagnosis of at least one additional comorbid component of metabolic syndrome: hypertension, hyperglycemia, dyslipidemia
• Clinical plan for discharge

Exclusion Criteria

• Age <18 years
• Pregnant patients
• Unable to safely ambulate (including patient or family perception of inability to safely ambulate)
• Lack of access to smart phone
• Unable or unwilling to wear Fitbit accelerometer device
• Unable to obtain informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mean daily steps	From enrollment to the end of the 3 month study period	Investigators will collect activity data utilizing a Fitbit accelerometer device. The primary outcome will be the mean number of daily steps averaged from 3 months of monitoring, compared between groups.

Secondary Outcome Measures

Name	Time	Method
Minutes of moderate to vigorous physical activity	From enrollment to the end of the 3 month study period	Investigators will collect activity data utilizing a Fitbit accelerometer device. As a secondary outcome, investigators will measure and compare minutes of moderate to vigorous physical activity (MVPA), as this metric will incorporate intensity of activity.
Psychometric survey: the Dietary Screener Questionnaire	At enrollment and 3 month follow-up	Participants will complete the Dietary Screener Questionnaire survey at baseline and 3-months.
Psychometric surveys: International Physical Activity Questionnaire	At enrollment and 3 month follow-up	Participants will complete the International Physical Activity Questionnaire survey at baseline and 3-months. This is reported on a continuous scale as physical activity metabolic equivalent of task (MET)-min per day or week.
Psychometric surveys: PROMIS Physical Function -- Short Form 4a	At enrollment and 3 month follow-up	Participants will complete the NIH PROMIS Physical Function -- Short Form 4a survey at baseline and 3-months. (min value: 4, max value: 20, higher score = higher physical functioning)
Psychometric surveys: PROMIS General Life Satisfaction -- Short Form 5a	At enrollment and 3 month follow-up	Participants will complete the NIH PROMIS General Life Satisfaction -- Short Form 5a survey at baseline and 3-months. (min value: 5, max value: 35, higher score = higher life satisfaction)
Psychometric surveys: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a	At enrollment and 3 month follow-up	Participants will complete the NIH PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a survey at baseline and 3-months. (min value: 8, max value: 40, higher score = higher self-efficacy)
Number of participants with a repeat visit to the emergency department	From enrollment to 3 month follow-up	Investigators will assess ED recidivism over the 3-month follow-up period, which will be defined as any repeat visit to the emergency department over the study period. This will be assessed primarily through review of the electronic medical record for any new ED encounter that occurred after initial enrollment date.

Trial Locations

Locations (1)

Sidney & Lois Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States