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HypertensionMETSNCT07119658

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

A study testing Composite intervention to address MetS in people with Hypertension and Hyperglycemia, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Hyperglycemia, Dyslipidemia
What is being tested?
Composite intervention to address MetS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
8 Jul 2025to 6 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney & Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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.

Being tested
Composite intervention to address MetS
Keywords
Metabolic Syndrome, Emergency Department
Medical subject headings
Hypertension, Hyperglycemia, Dyslipidemias, Metabolic Syndrome, Obesity, Overweight, Diabetes Mellitus, Hyperlipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Composite intervention to address MetSBehavioural

    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.

Study groups in NCT07119658
Study groupRoleWhat they receive
InterventionActive comparatorThe 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.
Receives: Behavioral: Composite intervention to address MetS
ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of the 3 month study period

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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)

    Measured: At enrollment and 3 month follow-up

  5. Psychometric surveys: PROMIS Physical Function -- Short Form 4a

    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)

    Measured: At enrollment and 3 month follow-up

  6. Psychometric surveys: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Daily Activities -- Short Form 8a

    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)

    Measured: At enrollment and 3 month follow-up

  7. Number of participants with a repeat visit to the emergency department

    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.

    Measured: From enrollment to 3 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2025
  2. Study start8 Jul 2025
  3. Primary completion6 May 2026
  4. Study completion6 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07119658
Sponsor's protocol ID
25821
Other IDs
RE2022-0000000327
Acronym
METS
Status last verified
Aug 2026
First submitted
29 Jul 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 3432232

  • Mattila J, Ding H, Mattila E, Sarela A. Mobile tools for home-based cardiac rehabilitation based on heart rate and movement activity analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:6448-52. doi: 10.1109/IEMBS.2009.5333540.

    PubMed 19964430

  • Brouwers RW, Kraal JJ, Traa SC, Spee RF, Oostveen LM, Kemps HM. Effects of cardiac telerehabilitation in patients with coronary artery disease using a personalised patient-centred web application: protocol for the SmartCare-CAD randomised controlled trial. BMC Cardiovasc Disord. 2017 Jan 31;17(1):46. doi: 10.1186/s12872-017-0477-6.

    PubMed 28143388

  • Satia JA. Diet-related disparities: understanding the problem and accelerating solutions. J Am Diet Assoc. 2009 Apr;109(4):610-5. doi: 10.1016/j.jada.2008.12.019. No abstract available.

    PubMed 19328255

  • Siopis G, Chey T, Allman-Farinelli M. A systematic review and meta-analysis of interventions for weight management using text messaging. J Hum Nutr Diet. 2015 Feb;28 Suppl 2:1-15. doi: 10.1111/jhn.12207. Epub 2014 Jan 31.

    PubMed 24480032

  • Smith DM, Duque L, Huffman JC, Healy BC, Celano CM. Text Message Interventions for Physical Activity: A Systematic Review and Meta-Analysis. Am J Prev Med. 2020 Jan;58(1):142-151. doi: 10.1016/j.amepre.2019.08.014. Epub 2019 Nov 21.

    PubMed 31759805

  • Fox SM 3rd, Naughton JP, Haskell WL. Physical activity and the prevention of coronary heart disease. Ann Clin Res. 1971 Dec;3(6):404-32. No abstract available.

    PubMed 4945367

  • KARVONEN MJ, KENTALA E, MUSTALA O. The effects of training on heart rate; a longitudinal study. Ann Med Exp Biol Fenn. 1957;35(3):307-15. No abstract available.

    PubMed 13470504

Questions about this trial

What is this clinical trial studying?

A study testing Composite intervention to address MetS in people with Hypertension and Hyperglycemia, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean daily steps (time frame: From enrollment to the end of the 3 month study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07119658, which also lists 101 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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