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

Indiana University

Status: Enrolling

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

Treatments: Behavioral: Composite intervention to address MetS

Study type: Interventional

Funder types: Other

Identifiers

NCT07119658

25821

RE2022-0000000327 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Composite intervention to address MetS

Control

No Intervention group

Description:

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.