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

NCT07119658 | Recruiting

• 2 other identifiers: 25821RE2022-0000000327
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Metabolic Syndrome; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Mean daily steps

  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.

  From enrollment to the end of the 3 month study period

Secondary Outcomes (7)

• Minutes of moderate to vigorous physical activity

  From enrollment to the end of the 3 month study period

• Psychometric survey: the Dietary Screener Questionnaire

  At enrollment and 3 month follow-up

• Psychometric surveys: International Physical Activity Questionnaire

  At enrollment and 3 month follow-up

• Psychometric surveys: PROMIS General Life Satisfaction -- Short Form 5a

  At enrollment and 3 month follow-up

• Psychometric surveys: PROMIS Physical Function -- Short Form 4a

  At enrollment and 3 month follow-up

Other Outcomes (4)

• Successful linkage into outpatient clinic follow-up

  From enrollment to 3 month follow-up

• Number of days wearing the Fitbit accelerometer during study period

  From enrollment to 3 month follow-up

• Demographic data

  This will be collected on Day 1 (i.e. day of screening and approaching for enrollment)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

The composite intervention will include an educational video outlining the adverse effects of metabolic syndrome and the benefit of walking (which patients will watch at time of enrollment in the emergency department), a written exercise "prescription" with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device to track activity, resources for healthy eating practices, periodic text message reminders over the 3 month study period, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit.

Behavioral: Composite intervention to address MetS

Control

NO INTERVENTION

The control group will receive usual care upon discharge from the emergency department. They will be given a Fitbit accelerometer device to wear for the study period to serve as a comparison but will not receive any specific recommendations for active or any additional component of the composite intervention.

Interventions

Composite intervention to address MetS BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Society for Academic Emergency Medicine: collaborator

Study Sites (1)

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

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MeSH Terms

Conditions

Hypertension; Hyperglycemia; Dyslipidemias; Metabolic Syndrome; Obesity; Overweight; Diabetes Mellitus; Hyperlipidemias; Emergencies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)