Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mean daily steps
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Composite intervention to address MetS (Behavioral)
Outcomes
Primary Outcomes
Mean daily steps
Time Frame: 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 Outcomes
- 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 Physical Function -- Short Form 4a(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 Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a(At enrollment and 3 month follow-up)
- Number of participants with a repeat visit to the emergency department(From enrollment to 3 month follow-up)
Investigators
Lauren Stewart
Assistant Professor of Emergency Medicine
Indiana University