Treating metabolic syndrome from the emergency department with a walking, Fitbit, and nutrition program
Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial
This pilot will test whether a combined program of education, a 150-minute/week walking prescription, a Fitbit, healthy eating resources, text reminders, and an urgent primary-care referral helps ambulatory adults with metabolic syndrome seen in the emergency department increase activity and healthier eating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07119658 on ClinicalTrials.gov |
What this trial studies
This is a small randomized pilot (n=20) comparing a multifaceted intervention to usual care among ambulatory adult ED patients with obesity and at least one metabolic comorbidity. The composite intervention includes an educational video, a written exercise prescription aiming for 150 minutes of walking per week, a Fitbit accelerometer, resources for healthy eating, periodic text message reminders, and expedited referral to primary care and the health system's Healthy Me clinic. Participants are randomized at discharge and followed to establish feasibility, changes in understanding, motivation, and preliminary behavior change in physical activity and diet. The trial is being conducted at a single urban hospital and is intended to inform a larger definitive trial if feasible.
Who should consider this trial
Good fit: Ambulatory adults (≥18 years) presenting to the emergency department with BMI ≥30 kg/m2 and at least one additional metabolic comorbidity (hypertension, hyperglycemia, or dyslipidemia) who are planned for discharge, have a smartphone, and are willing to wear a Fitbit are ideal candidates.
Not a fit: Patients who cannot safely ambulate, lack a smartphone, are unwilling to wear the Fitbit, are pregnant, or require hospital admission are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could increase patients' physical activity and healthy eating and improve linkage to primary care, potentially lowering cardiometabolic risk.
How similar studies have performed: Previous outpatient interventions using pedometers/Fitbits, exercise prescriptions, and text messaging have shown modest improvements in activity and weight, but initiating a composite program directly from the emergency department is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana
- Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.