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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Composite intervention to address MetS

    Behavioral

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mean daily steps

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.

Time frame
From enrollment to the end of the 3 month study period

Secondary outcomes

1

Minutes of moderate to vigorous physical activity

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.

Time frame
From enrollment to the end of the 3 month study period
2

Psychometric survey: the Dietary Screener Questionnaire

Participants will complete the Dietary Screener Questionnaire survey at baseline and 3-months.

Time frame
At enrollment and 3 month follow-up
3

Psychometric surveys: International Physical Activity Questionnaire

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.

Time frame
At enrollment and 3 month follow-up
4

Psychometric surveys: PROMIS General Life Satisfaction -- Short Form 5a

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)

Time frame
At enrollment and 3 month follow-up

Other outcomes

1

Successful linkage into outpatient clinic follow-up

Investigators will determine whether intervention patients were able to successfully follow up in the health system's outpatient clinic with the referral provided. This will be determined through review of the electronic medical record.

Time frame
From enrollment to 3 month follow-up
2

Number of days wearing the Fitbit accelerometer during study period

Investigators will describe the number of totals days participants actually wore the Fitbit accelerometer device over the study period, allowing for activity data collection.

Time frame
From enrollment to 3 month follow-up
3

Demographic data

As an additional exploration, we will collect pertinent data on the screening and enrollment process, including demographic data on which patients are screened, approached, and ultimately enrolled. We will ask those who decline enrollment to briefly provide us information (i.e. short-form, open-ended response) on why they are declining to participate, to gain further knowledge on the targeted ED population for this intervention.

Time frame
This will be collected on Day 1 (i.e. day of screening and approaching for enrollment)
4

Semi-structured interview data

To better understand reasons for failure and success of adherence to the composite intervention, we will also conduct semi-structured interviews at three-month follow-up of patients in the intervention group. Thematic analysis will be performed to identify theoretical constructs, processes, and themes surrounding the patients' experience with the composite intervention.

Time frame
At 3-month follow-up (for those in intervention group)

Sponsors and contacts

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Indiana University

Lead sponsor

Society for Academic Emergency Medicine

Collaborator