Composite Intervention for Metabolic Syndrome

(METS Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pregnancy, Inability to ambulate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to assist individuals with metabolic syndrome, a condition involving high blood pressure, high blood sugar, and unhealthy cholesterol levels. The trial tests a combination of tools, including educational videos, exercise plans, Fitbits, and healthy eating resources, to determine their effectiveness in motivating healthier lifestyles. This composite intervention provides a comprehensive program for participants, who will either receive this program or continue with their usual care for comparison. The trial suits adults who have visited the emergency department, have a BMI of 30 or more, and experience conditions like high blood pressure or high blood sugar. As an unphased trial, this study offers an opportunity to contribute to innovative research that could lead to new health strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on lifestyle changes like exercise and healthy eating.

What prior data suggests that this composite intervention is safe for metabolic syndrome patients?

Past studies have shown that using Fitbit devices and text message reminders helps people increase physical activity and manage weight. Research indicates these methods are generally easy to use, with few reports of negative effects. One study found that Fitbits and self-monitoring techniques, such as tracking activity and receiving text prompts, helped people maintain healthy habits without major problems.

Another study examined a lifestyle program using mobile apps and found it both feasible and well-received by participants. This suggests that using technology for health improvements, as in this combined approach, is safe for most people. While specific data on negative effects for this particular program is unavailable, similar methods have been safely used in other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this composite intervention for metabolic syndrome because it integrates several innovative strategies. Unlike standard treatments that might focus solely on medication or lifestyle changes, this approach combines an educational video, personalized exercise goals, and healthy eating resources. It also leverages technology by using a Fitbit to track activity and provides ongoing motivation through text message reminders. This holistic and interactive approach aims to empower patients with the tools and knowledge they need to make lasting lifestyle changes, potentially offering more sustainable results than traditional methods.

What evidence suggests that this trial's composite intervention could be effective for metabolic syndrome?

Research has shown that using a Fitbit can increase physical activity and assist with weight control. In this trial, participants in the intervention arm will receive a composite intervention that includes a Fitbit, an educational video, an exercise prescription, and other resources. Studies have found that digital tools like text message reminders and online resources effectively promote healthier eating habits and lower the risk of obesity. Additionally, educational videos can improve understanding and motivation for lifestyle changes. Combining these elements may help manage metabolic syndrome by encouraging more exercise and healthier eating. Although this method is still under study, early results suggest it could positively impact lifestyle changes. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for emergency department patients with metabolic syndrome (MetS), which includes conditions like diabetes, hypertension, and high cholesterol. Participants should be interested in lifestyle changes to manage MetS. Those who are already receiving comprehensive MetS care or cannot commit to the study requirements are excluded.

Inclusion Criteria

I am 18 or older and can walk on my own.

I am scheduled to be discharged from the hospital.

I have been diagnosed with a condition like high blood pressure, high blood sugar, or abnormal cholesterol levels.

Exclusion Criteria

I am under 18 years old.

Pregnant patients

Lack of access to smart phone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Enrollment and Initial Intervention

Participants are enrolled and receive the initial intervention, including an educational video, exercise prescription, and Fitbit device

1 day

1 visit (in-person)

Intervention Period

Participants follow the intervention plan, including walking goals, healthy eating resources, and text message reminders

12 weeks

Follow-up

Participants are monitored for adherence and outcomes, including follow-up visits to the Healthy Me clinic

3 months

1 visit (in-person), ongoing monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Composite intervention

Trial Overview The trial tests a composite intervention aimed at improving MetS management. It includes an educational video, exercise prescription targeting 150 minutes of walking per week, a Fitbit device for tracking activity, resources for healthy eating, text reminders, and urgent referrals to primary care.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

The 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.

Group II: Intervention Active Control 1 Intervention

The 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.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Society for Academic Emergency Medicine

Collaborator

Trials

3

Recruited

280+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07119658

NCT07119658 | Targeting Metabolic Syndrome From the ... The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7589007/

Fitbit-Based Interventions for Healthy Lifestyle Outcomes The use of Fitbit devices in interventions has the potential to promote healthy lifestyles in terms of physical activity and weight.

3. jmir.org jmir.org/2025/1/e60602

and Web-Based Interventions for Promoting Healthy Diets, ... This systematic review aimed to evaluate the effectiveness of mobile and web-based digital interventions in promoting healthy diets, reducing obesity risk, ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S1438887124000451

Digitally Delivered Interventions to Improve Nutrition Behaviors ... This systematic review is conducted to assess the effectiveness of digitally delivered interventions in improving nutritional behaviors and nutrition‐related ...

5. journals.sagepub.com journals.sagepub.com/doi/full/10.1089/tmj.2014.0176

Wearable Sensor/Device (Fitbit One) and SMS Text- ... The relationship between self-monitoring, outcome expectancies, difficulties with eating and exercise, and physical activity and weight loss treatment outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8057802/

The Effect of a Lifestyle Intervention Program Using a Mobile ... This study aimed to examine the preliminary effect, feasibility, and acceptability of a lifestyle intervention program using a mobile application (app)

7. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11383-4

Utilizing technology for diet and exercise change in complex ... This study evaluated the implementation of a ubiquitously accessible patient-centred digital health diet and exercise service.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02188875

NCT02188875 | Fitbit One and Text Messaging Prompts to ... Previous studies suggest self-regulatory techniques including self-monitoring, and SMS text-messaging as an intervention modality, can modify health behaviors ...

9. mdpi.com mdpi.com/2072-6643/17/5/872

Tailored Exercise Intervention in Metabolic Syndrome This study aims to evaluate the effectiveness of a 6-month Adapted Personalized Motor Activity (AMPA) program for improving the health outcomes of individuals ...