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NCT07119658Completed

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

Source: ClinicalTrials.gov · Last updated 19 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
29 Jul 2025
Start date
8 Jul 2025
Primary completion date
6 May 2026
Lead sponsor
Indiana University
NCT number
NCT07119658

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 8 Jul 2025 to the primary completion date, 6 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age \<18 years

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sidney & Lois Eskenazi Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.