Diabetes, Dyslipidemia, Emergency Medicine, Hyperglycemia, Hyperlipidemia, Hypertension, Metabolic Syndrome, Obesity &Amp; Overweight
Conditions
Keywords
Metabolic Syndrome, Emergency Department
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.
Interventions
BEHAVIORALComposite intervention to address MetS
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.
Sponsors
Indiana University
Society for Academic Emergency Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean daily steps | 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
| Measure | Time frame | Description |
|---|---|---|
| Minutes of moderate to vigorous physical activity | From enrollment to the end of the 3 month study period | Investigators will collect activity data utilizing a Fitbit accelerometer device. As a secondary outcome, investigators will measure and compare minutes of moderate to vigorous physical activity (MVPA), as this metric will incorporate intensity of activity. |
| Psychometric survey: the Dietary Screener Questionnaire | At enrollment and 3 month follow-up | Participants will complete the Dietary Screener Questionnaire survey at baseline and 3-months. |
| Psychometric surveys: International Physical Activity Questionnaire | At enrollment and 3 month follow-up | Participants will complete the International Physical Activity Questionnaire survey at baseline and 3-months. This is reported on a continuous scale as physical activity metabolic equivalent of task (MET)-min per day or week. |
| Psychometric surveys: PROMIS General Life Satisfaction -- Short Form 5a | At enrollment and 3 month follow-up | Participants will complete the NIH PROMIS General Life Satisfaction -- Short Form 5a survey at baseline and 3-months. (min value: 5, max value: 35, higher score = higher life satisfaction) |
| Psychometric surveys: PROMIS Physical Function -- Short Form 4a | At enrollment and 3 month follow-up | Participants will complete the NIH PROMIS Physical Function -- Short Form 4a survey at baseline and 3-months. (min value: 4, max value: 20, higher score = higher physical functioning) |
| Psychometric surveys: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a | At enrollment and 3 month follow-up | Participants will complete the NIH PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a survey at baseline and 3-months. (min value: 8, max value: 40, higher score = higher self-efficacy) |
| Number of participants with a repeat visit to the emergency department | From enrollment to 3 month follow-up | Investigators will assess ED recidivism over the 3-month follow-up period, which will be defined as any repeat visit to the emergency department over the study period. This will be assessed primarily through review of the electronic medical record for any new ED encounter that occurred after initial enrollment date. |
Countries
United States
Outcome results
None listed