Physical activity for the prevention and treatment of metabolic disorders.
Luca Montesi, Simona Moscatiello, Marcella Malavolti...
https://pubmed.ncbi.nlm.nih.gov/23657989/Actively Recruiting
Led by Indiana University · Updated on 2025-08-13
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating a multifaceted intervention for metabolic syndrome MetS in patients visiting the emergency department to see if it is feasible and can improve physical activity and healthy eating habits. This pilot trial will involve 20 participants randomly assigned to either the intervention or usual care group. The study aims to increase understanding and motivation related to MetS by offering education, devices, and support. The intervention group receives a six-part program including an educational video about MetS and benefits of walking, a written exercise prescription targeting 150 minutes of walking per week, a Fitbit accelerometer to track activity, written healthy eating resources, regular text message reminders over three months, and an urgent referral for follow-up care in primary care and a health clinic. The control group receives usual care and a Fitbit device but no specific behavioral guidance. Participants will be monitored for three months starting from enrollment, with measurements including average daily steps, minutes of moderate to vigorous physical activity, and several surveys assessing diet, physical activity, life satisfaction, physical function, and self-efficacy at enrollment and follow-up. Researchers will also track emergency department revisits. The primary outcome is the mean daily steps during the study period, with all participants wearing the Fitbit device to monitor activity continuously.
CONDITIONS
Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial
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Indiana University
Lead Sponsor
Society for Academic Emergency Medicine
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Composite Intervention (Fitbit, Education, Resources, Referrals) | Usual Care (Standard Discharge Instructions) |
|---|---|---|
| What is it? | A multi-component behavioral program delivered at emergency department discharge, including a Fitbit device, educational video on metabolic syndrome, walking prescription, regular motivational text messages, healthy eating resources, and referral to follow-up care. | Standard discharge instructions without additional exercise or behavioral components, representing usual care for patients discharged from the emergency department with metabolic syndrome. |
| Primary use | Supports increased physical activity and promotes healthier lifestyle behaviors to address metabolic syndrome risk factors. | Provides standard post-discharge advice, without specific behavioral or exercise-focused support. |
| How is it given or performed? | At hospital discharge, participants receive a wearable Fitbit tracker to monitor activity, watch an educational video, receive a walking prescription, healthy eating resources, frequent reminder texts for 3 months, and get referrals for ongoing support. | Participants receive the usual set of discharge instructions typical for emergency department patients, with no added behavioral intervention or technology. |
| What is known from evidence? | Behavioral interventions including wearable activity trackers, motivational text messages, and structured education can improve physical activity and may support healthier behavior change. The trial’s intervention brings together several proven strategies, but its specific effect in this emergency department setting for metabolic syndrome is not yet known. | Standard discharge instructions alone have limited impact on patient physical activity or metabolic risk. Most patients do not receive structured exercise or diet support as part of routine emergency department discharge. |
| Important limitations | The effects of the multi-component intervention are not yet established and trial results are pending. Long-term adherence to wearable use, text reminders, and behavior change may be challenging for some participants. Accessibility issues (such as access to a smartphone) could limit generalisability. | Usual care lacks structured follow-up, motivational support, or technology, which may lead to low engagement in positive behavior change or preventive actions. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) at the emergency department
Duration - 3 months
Participants receive a composite behavioral intervention including a Fitbit device, an educational video, a walking exercise prescription, healthy eating resources, periodic reminder texts, and referrals for follow-up care. Control participants receive usual care and wear a Fitbit device without active intervention.
1 enrollment visit at the emergency department and periodic text reminders 2 to 3 times per week
Duration - Up to 3 months post-enrollment
Participants complete psychometric surveys and physical activity assessments at enrollment and at 3 months to evaluate intervention effects and health outcomes.
2 visits (enrollment and 3-month follow-up)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/26511854/Indiana University
Lead Sponsor
Society for Academic Emergency Medicine
Collaborating Sponsor