Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Composite intervention to address MetS.
- Who it may be relevant to
- Registry conditions: Hypertension, Hyperglycemia, Dyslipidemia, Metabolic Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Behavioral Composite 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
Primary outcome measures
- Mean daily steps [Time frame: From enrollment to the end of the 3 month study period]
Secondary outcome measures (7)
- Minutes of moderate to vigorous physical activity [Time frame: From enrollment to the end of the 3 month study period]
- Psychometric survey: the Dietary Screener Questionnaire [Time frame: At enrollment and 3 month follow-up]
- Psychometric surveys: International Physical Activity Questionnaire [Time frame: At enrollment and 3 month follow-up]
- Psychometric surveys: PROMIS General Life Satisfaction -- Short Form 5a [Time frame: At enrollment and 3 month follow-up]
- Psychometric surveys: PROMIS Physical Function -- Short Form 4a [Time frame: At enrollment and 3 month follow-up]
- Psychometric surveys: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a [Time frame: At enrollment and 3 month follow-up]
- Number of participants with a repeat visit to the emergency department [Time frame: From enrollment to 3 month follow-up]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Sidney & Lois Eskenazi Hospital — Indianapolis
Publications
- Sista AK, Klok FA. Late outcomes of pulmonary embolism: The post-PE syndrome. Thromb Res. 2018 Apr;164:157-162. doi: 10.1016/j.thromres.2017.06.017. Epub 2017 Jun 16. PMID 28641836
- Piercy KL, Troiano RP, Ballard RM, Carlson SA, Fulton JE, Galuska DA, George SM, Olson RD. The Physical Activity Guidelines for Americans. JAMA. 2018 Nov 20;320(19):2020-2028. doi: 10.1001/jama.2018.14854. PMID 30418471
- Lee IM, Shiroma EJ, Kamada M, Bassett DR, Matthews CE, Buring JE. Association of Step Volume and Intensity With All-Cause Mortality in Older Women. JAMA Intern Med. 2019 Aug 1;179(8):1105-1112. doi: 10.1001/jamainternmed.2019.0899. PMID 31141585
- Dontje ML, de Groot M, Lengton RR, van der Schans CP, Krijnen WP. Measuring steps with the Fitbit activity tracker: an inter-device reliability study. J Med Eng Technol. 2015;39(5):286-90. doi: 10.3109/03091902.2015.1050125. Epub 2015 May 27. PMID 26017748
- Feehan LM, Geldman J, Sayre EC, Park C, Ezzat AM, Yoo JY, Hamilton CB, Li LC. Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. JMIR Mhealth Uhealth. 2018 Aug 9;6(8):e10527. doi: 10.2196/10527. PMID 30093371
- Stich C, Knauper B, Tint A. A scenario-based dieting self-efficacy scale: the DIET-SE. Assessment. 2009 Mar;16(1):16-30. doi: 10.1177/1073191108322000. Epub 2008 Aug 14. PMID 18703821
- McAuley E. Self-efficacy and the maintenance of exercise participation in older adults. J Behav Med. 1993 Feb;16(1):103-13. doi: 10.1007/BF00844757. PMID 8433355
- Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to measure social support for diet and exercise behaviors. Prev Med. 1987 Nov;16(6):825-36. doi: 10.1016/0091-7435(87)90022-3. PMID 3432232
Identifiers
NCT: NCT07119658 · 25821 · RE2022-0000000327