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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
No Placebo-Only Group
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 belowSelect...
I am at least 22 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an eating disorder such as anorexia or bulimia.
Select...
I am currently on medication for diabetes or weight loss.
Select...
I have had or am planning to have surgery to lose weight.
Select...
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
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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.
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
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