What side effects are associated with this type of intervention?

Common treatments for obesity include behavioral interventions, pharmacotherapy, and mHealth platforms. Behavioral interventions like diet and exercise typically have minimal side effects, such as temporary discomfort or fatigue. Pharmacotherapy, including drugs like semaglutide, can cause gastrointestinal issues like nausea and diarrhea, and may have more serious long-term risks such as pancreatitis. mHealth platforms, which use real-time data and coaching, are generally well-tolerated but may raise data privacy concerns and potentially increase anxiety due to constant monitoring.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including GLP-1 receptor agonists like liraglutide and semaglutide. Liraglutide (Saxenda) was approved for chronic weight management in adults with obesity or overweight with at least one weight-related condition. Semaglutide (Wegovy) has also been approved for weight management and has shown significant weight loss in clinical trials. These medications work by mimicking the hormone GLP-1, which helps regulate appetite and food intake. The use of CGM with mHealth platforms, as studied in recent trials, aims to enhance behavioral changes through real-time glucose data and targeted coaching, potentially improving adherence and outcomes in weight management.

What other types of research exist?

Promising alternatives to CGM with mHealth platforms for obesity patients include telemedicine interventions, mobile phone-based diabetes management programs, and intensive lifestyle interventions. These approaches leverage technology for real-time data monitoring, personalized coaching, and behavioral change support, showing efficacy in improving glycemic control and promoting weight loss.

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Behavioural Intervention

Signos mHealth Platform for Weight Loss (SWEET Trial)

N/A

Waitlist Available

Research Sponsored by Signos Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be at least 22 years old

Be older than 18 years old

Must not have

Suffer from an eating disorder like anorexia or bulimia

Are currently taking certain medications for diabetes or weight loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial uses a device that continuously tracks blood sugar levels and a mobile app to help people with obesity manage their weight. The app provides personalized advice on diet and exercise based on the blood sugar data. The goal is to see if this approach helps people stick to their health goals better.

Who is the study for?

This trial is for adults who are dealing with obesity or metabolic syndrome and want to manage their weight. Participants should be interested in using a mobile health platform (Signos System) alongside standard lifestyle education to achieve their weight goals.

What is being tested?

The study tests whether the Signos mHealth Platform, which includes continuous glucose monitoring and personalized coaching, can help people lose weight more effectively than just getting standard lifestyle advice.

What are the potential side effects?

Since this trial involves non-medical interventions like diet and exercise guidance through an app, side effects may include typical responses to dietary changes or increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 22 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an eating disorder such as anorexia or bulimia.

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I am currently on medication for diabetes or weight loss.

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I have had or am planning to have surgery to lose weight.

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I have severe kidney disease, untreated thyroid issues, or skin conditions affecting glucose monitor placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Total Body Weight Loss (TBWL%)

Responder Rate

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Signos SystemExperimental Treatment1 Intervention

For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.

Group II: Standard Lifestyle EducationActive Control1 Intervention

The "Active Comparator: Standard Lifestyle Education" arm in the clinical trial refers to a control group that receives conventional lifestyle modification advice instead of the experimental Signos System.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include lifestyle interventions, pharmacotherapy, and surgical options. Lifestyle interventions focus on diet, physical activity, and behavioral changes to reduce caloric intake and increase energy expenditure. Pharmacotherapy involves medications that suppress appetite, increase satiety, or reduce nutrient absorption. Surgical options, such as bariatric surgery, physically restrict food intake or alter digestive processes. The use of Continuous Glucose Monitoring (CGM) with an mHealth platform, as studied in recent trials, leverages real-time glucose data to promote behavioral changes through targeted coaching. This approach helps patients understand the immediate impact of their dietary choices on glucose levels, thereby encouraging healthier eating habits and better adherence to weight management plans. This matters for obesity patients as it provides personalized feedback and support, which can lead to more effective and sustainable weight loss.

Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?Weight loss in neurodegenerative disorders.

Find a Location

Who is running the clinical trial?

Signos IncLead Sponsor

2 Previous Clinical Trials

120,000 Total Patients Enrolled

Lindus Health, Inc.UNKNOWN

Stephanie Kim, MDStudy ChairSignos Inc

1 Previous Clinical Trials

20,000 Total Patients Enrolled

~104 spots leftby Dec 2024

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