Signos mHealth Platform for Weight Loss

(SWEET Trial)

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

380 Participants Needed

Trial Summary

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 data supports the effectiveness of the Signos mHealth Platform treatment for weight loss?

Research shows that mobile health (mHealth) apps for weight loss, like the Signos mHealth Platform, are effective because they allow users to track their progress, set goals, and receive feedback, which can motivate and educate them. Personalization and simplicity in these apps are key factors that enhance user engagement and success in losing weight. ^{1 2 3 4 5}

How does the Signos mHealth Platform for Weight Loss treatment differ from other weight loss treatments?

The Signos mHealth Platform for Weight Loss is unique because it uses a mobile health (mHealth) approach, leveraging smartphone technology to provide personalized feedback, self-monitoring, and motivation for weight loss. This treatment focuses on user engagement through simple, attractive apps and personalized messaging, which is different from traditional weight loss methods that may not incorporate technology or personalization to this extent. ^{1 4 6 7 8}

What is the purpose of this trial?

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.

Research Team

Stephanie Kim, MD

Principal Investigator

Signos Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Professional dietary coaching within a group chat using a smartphone application for weight loss: a randomized controlled trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility of a lifestyle intervention for overweight/obese endometrial and breast cancer survivors using an interactive mobile application. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Exploring Sex Differences in the Effectiveness of Telehealth-Based Health Coaching in Weight Management in an Employee Population. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Consumer perspectives on mHealth for weight loss: a review of qualitative studies. [2018]

5. Canada 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The Dietary Intervention to Enhance Tracking with Mobile Devices (DIET Mobile) Study: A 6-Month Randomized Weight Loss Trial. [2022]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Improving Childhood Obesity Treatment Using New Technologies: The ETIOBE System. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

PEGASO: A Personalised and Motivational ICT System to Empower Adolescents Towards Healthy Lifestyles. [2019]