Signos mHealth Platform for Weight Loss

(SWEET Trial)

Not currently recruiting at 4 trial locations

Overseen By Brittany Berre

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Signos Inc

Must not be taking: Diabetes medications, Weight loss drugs

Disqualifiers: Diabetes, Eating disorders, Severe kidney disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether the Signos app, combined with continuous glucose monitoring (CGM), can help individuals who are overweight or obese achieve their weight loss goals. The app provides personalized health recommendations, and the study will compare this approach to standard lifestyle advice. Participants should be familiar with using a smartphone and have a Body Mass Index (BMI) between 25 and 40, without diabetes or certain other medical conditions. As an unphased trial, this study offers a unique opportunity to contribute to innovative weight loss research and receive personalized health insights.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications for diabetes or weight loss.

What prior data suggests that the Signos mHealth Platform is safe for weight loss?

Research shows that the Signos mHealth Platform, which includes a continuous glucose monitor (CGM) and a mobile app, is generally easy to use for weight management. Many people have used this system in previous studies without major safety issues. The CGM device is already commonly used to check blood sugar levels and is safe for people without diabetes. Although researchers are still studying the platform's effectiveness for weight loss, the technology itself has not caused significant problems for users. This suggests that the treatment is likely safe for most people considering joining a trial using this system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Signos mHealth Platform for weight loss because it offers a personalized approach to managing health. Unlike standard treatments that provide generic lifestyle advice, the Signos system uses continuous glucose monitoring (CGM) data to give tailored recommendations. This technology allows users to see how their diet and lifestyle choices affect their glucose levels in real-time, potentially leading to more effective weight loss. By customizing guidance based on individual data, this platform could revolutionize how we approach weight management, making it more precise and personalized.

What evidence suggests that the Signos mHealth Platform is effective for weight loss?

Research has shown that the Signos mHealth Platform, which includes continuous glucose monitoring (CGM), can aid in weight loss. In this trial, participants in the Signos System arm will use CGM data to receive personalized recommendations for promoting general health and wellness. One study found that individuals using a similar online program lost an average of 3.6% of their body weight. CGM provides real-time feedback on how the body reacts to food and exercise, helping users make better dietary and activity choices. The Signos system combines this information with personalized coaching and nutrition advice. This approach is believed to help people without diabetes manage their weight more effectively. Additionally, a large study with 20,000 participants is currently investigating the effectiveness of CGMs for weight loss. ^{2 3 4 5 6}

Who Is on the Research Team?

Stephanie Kim, MD

Principal Investigator

Signos Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Be overweight or obese, which we define as having a Body Mass Index (BMI) between 25 and 40

Have and know how to use a smartphone that's compatible with the Signos app

I am at least 22 years old.

Exclusion Criteria

Have severe allergies to the sticky part of glucose monitors

I have an eating disorder such as anorexia or bulimia.

I am currently on medication for diabetes or weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Signos mHealth platform with CGM data for personalized weight management

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Signos mHealth Platform
• Standard Lifestyle Education

Trial Overview 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.

How Is the Trial Designed?

Group I: Signos System Experimental Treatment 1 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 Education Active Control 1 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.

Who Is Running the Clinical Trial?

Signos Inc

Lead Sponsor

Trials

3

Recruited

120,000+

Lindus Health, Inc.

Collaborator

Trials

1

Recruited

380+

Published Research Related to This Trial

The telehealth-based lifestyle therapeutics (THBC) program was effective in promoting weight loss, with obese participants losing an average of 3.6% of their body weight compared to 2.5% for overweight participants, indicating a significant difference based on initial BMI category.

There were no differences in weight loss outcomes between men and women, and participants reported high satisfaction with the program, suggesting that THBC is a valuable tool for weight management in an employer population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. Johnson, KE., Alencar, MK., Miller, B., et al.[2021]

In a 12-week study involving 112 overweight Japanese adults, those receiving professional dietary coaching via a smartphone app lost significantly more weight (average -1.4 kg) compared to the control group (-0.1 kg).

Participants who frequently uploaded meal photos to the group chat not only lost more weight but also showed significant improvements in cardiometabolic risk factors, indicating that active engagement in the program enhances health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. Tanaka, K., Sasai, H., Wakaba, K., et al.[2022]

Users prefer mHealth weight loss apps that are simple, attractive, and allow for self-monitoring with feedback, emphasizing the importance of personalization and engaging content.

Key barriers to using these apps include technological issues and message overload, highlighting the need for careful consideration of message tone, structure, and delivery frequency to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer perspectives on mHealth for weight loss: a review of qualitative studies. Lyzwinski, LN., Caffery, LJ., Bambling, M., et al.[2018]

A one-month lifestyle intervention using the LoseIt! app led to significant weight loss in overweight/obese cancer survivors, with participants losing an average of 6.4 kg and showing reductions in BMI and waist circumference.

The intervention improved participants' self-efficacy regarding weight management, as indicated by a significant increase in the Weight Efficacy Lifestyle Questionnaire score, demonstrating the app's effectiveness in promoting healthier lifestyle choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. McCarroll, ML., Armbruster, S., Pohle-Krauza, RJ., et al.[2022]

In the CITY trial, which involved 242 participants over 24 months, higher engagement with a smartphone app was associated with greater weight loss compared to personal coaching, particularly in the first 6 months.

Despite initial high engagement, usage of the app and its components dropped significantly over time, suggesting that more flexible prompting strategies may be needed to maintain participant engagement throughout the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial. Lin, PH., Grambow, S., Intille, S., et al.[2019]

Citations

1. ctv.veeva.com ctv.veeva.com/study/using-signos-mhealth-platform-in-adults-for-weight-management

Using Signos mHealth Platform in Adults for Weight ... The investigators hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals ...

2. withpower.com withpower.com/trial/phase-body-weight-2024-2f81a

Signos mHealth Platform for Weight Loss (SWEET Trial) The telehealth-based lifestyle therapeutics (THBC) program was effective in promoting weight loss, with obese participants losing an average of 3.6% of their ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05121844

Use of Continuous Glucose Monitoring in Non-Diabetic ... The scope of this study is to enroll existing and new Signos users in a volunteer study that utilizes a continuous glucose monitor (CGM) and mobile health ...

4. signos.com signos.com/blog/cgms-for-weight-loss

CGMs for Weight Loss: The Latest Science - Signos This IRB study—with 20,000 participants—will collect three years of CGM data to show how efficacious the Signos program is in helping people lose weight, ...

5. app.trialscreen.org app.trialscreen.org/trials/using-signos-mhealth-platform-adults-weight-management-trial-nct06214221

Using Signos mHealth Platform in Adults for Weight ... Participants will be using the Signos mHealth platform to monitor their wellness, body weight, and composition and their progress will be ...

6. trialx.com trialx.com/clinical-trials/listings/259133/using-signos-mhealth-platform-in-adults-for-weight-management/

Using Signos mHealth Platform in Adults for Weight ... Clinical trial for Weight Loss | Metabolic Syndrome | Overweight and Obesity , Using Signos mHealth Platform in Adults for Weight Management.