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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07119658
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 8, 2025
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention
    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.
  • No Intervention: Control
    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.

Primary Outcome Measure

Mean daily steps [ Time Frame: From enrollment to the end of the 3 month study period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney & Lois Eskenazi HospitalIndianapolisIndiana46202
Shuhei Misawa, BS
[email protected]
3172783919
Lauren Stewart, MD
317 880 3900
Lauren Stewart, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Sidney & Lois Eskenazi Hospital· Indianapolis, IN

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