Digital Weight Loss Intervention for Obesity and Type 2 Diabetes Risk

(mLIFE Trial)

Overseen By Brie Turner-McGrievy, PhD, MS, RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Blood glucose medications

Disqualifiers: Over 65, Type 2 diabetes, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a digital app can aid in weight loss and reduce the risk of type 2 diabetes. The app, called mLIFE, uses engaging, game-like features to promote healthy habits, such as tracking food intake and obtaining social support. Researchers aim to determine if the gaming version of the app results in greater weight loss and improved social support compared to the non-gaming version. The trial seeks adults who are overweight, own a smartphone, and have three or more risk factors for type 2 diabetes. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new, engaging methods for managing weight and preventing diabetes.

Will I have to stop taking my current medications?

The trial requires that you do not use medications that may impact blood glucose. If you are taking such medications, you may need to stop them to participate.

What prior data suggests that this digital intervention is safe for weight loss?

Research has shown that the mLIFE app, tested for weight loss, may help people manage their weight and lower the risk of type 2 diabetes. The app allows users to track habits and receive support from others. Studies have found that mobile apps like mLIFE can improve self-care and diabetes control, suggesting they are generally safe.

The mLIFE app also uses social gaming to encourage weight loss by awarding points for social support. Previous research found this game-like approach effectively increases engagement without major safety concerns. Overall, these features are well-tolerated, with no significant reports of negative effects from using the app.

In summary, the mLIFE app's features appear safe based on existing research about similar mobile health tools. However, as with any new treatment, individuals should consider their own health conditions and consult healthcare providers before participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mLIFE app treatments for obesity and Type 2 diabetes risk because they offer a unique approach by integrating digital tools for self-regulation and social support. Unlike traditional methods like diet plans and medications, the mLIFE app introduces a gamified experience, fostering healthy competition among users to encourage sustained engagement and motivation. This social gaming element aims to make weight loss efforts more interactive and enjoyable, potentially leading to better adherence and outcomes. Moreover, the app's self-regulation features empower users to track their progress and make informed decisions, distinguishing it from more passive treatment options.

What evidence suggests that this digital weight loss intervention could be effective for obesity and Type 2 diabetes risk?

Research has shown that the mLIFE app, which aids in self-control and support from others, can effectively assist with weight loss. In this trial, participants will be assigned to different groups using the mLIFE app. One group will use a gamified version of the app, which includes points to encourage support from friends, resulting in more weight loss than similar programs without this feature. This version allows users to send encouraging messages and "likes" to each other upon reaching goals, fostering a supportive community. Early results suggest that adding game-like features enhances effectiveness, leading to greater weight loss. Evidence indicates that these social features can help individuals with obesity or at risk for Type 2 diabetes lose weight over 12 months. ^{3 6 7 8 9}

Who Is on the Research Team?

Brie Turner-McGrievy, PhD, MS, RD

Principal Investigator

University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with obesity or overweight, having a BMI of 25-49.9 kg/m2 and at least three risk factors for Type 2 diabetes but not diagnosed with it. Participants must own a smartphone, be willing to change their diet and exercise habits, and not be on medications affecting blood glucose or involved in other weight loss programs.

Inclusion Criteria

I am not taking any medications that affect my blood sugar levels.

≥3 T2DM risk factors (as defined by the American Diabetes Association)

Must not be currently participating in a weight loss study or program

Exclusion Criteria

I have been diagnosed with type 2 diabetes.

I have lost more than 10 pounds in the last 6 months.

I am over 65 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation and Baseline Assessment

Participants attend a study orientation, complete all baseline measures, and are randomized into groups

1 week

1 visit (in-person)

Intervention

Participants engage in a 1-year behavioral intervention using the mLIFE app, with or without gamification, including twice-weekly podcasts and daily tracking

52 weeks

Ongoing virtual engagement

Assessment

Participants complete assessments at 6 and 12 months to evaluate changes in weight, diet, and physical activity

1 week

2 visits (in-person or virtual)

Follow-up

Participants are monitored for sustained weight loss and behavioral changes after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mLIFE app (self-regulation features)
• mLIFE app (social support features)
• Podcasts and tips of the day (within app)
• standard mLIFE app (social support features)

Trial Overview The study tests whether an app called mLIFE that includes social gaming features can help people lose more weight over a year compared to the same app without these features. The app provides podcasts, tips, self-regulation tools, and rewards supportive interactions aimed at reducing calorie intake and increasing physical activity.

How Is the Trial Designed?

Group I: Gamified mLIFE app group Experimental Treatment 3 Interventions

Participants allocated to this group will be provided with elements of social gaming and healthy competition within the mLIFE app.

Group II: standard mLIFE app Active Control 3 Interventions

Participants in this group will receive the same intervention as the experimental group, but some features of the App will not facilitate gaming or competition.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

Published Research Related to This Trial

Inpatient rehabilitation for obesity should involve a multidisciplinary team, including various health professionals, to effectively improve weight loss and address related health issues.

Internet-based and mobile health (mHealth) technologies can enhance long-term obesity rehabilitation by improving treatment compliance and engagement, suggesting a promising direction for future research in this field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity and outpatient rehabilitation using mobile technologies: the potential mHealth approach. Castelnuovo, G., Manzoni, GM., Pietrabissa, G., et al.[2022]

A study involving 22 participants from a weight management clinic in Singapore identified key features that weight loss apps should include for a multi-ethnic population with overweight and obesity, such as comprehensive calorie counters and individualized behavior change recommendations.

Participants emphasized the importance of flexibility in food logging and the need for apps to provide just-in-time reminders about the consequences of their choices, suggesting that future apps could benefit from artificial intelligence to offer personalized support for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Essential elements of weight loss apps for a multi-ethnic population with high BMI: a qualitative study with practical recommendations. Chew, HSJ., Lim, SL., Kim, G., et al.[2023]

The use of digital self-management solutions for Type 2 diabetes, such as DM4All and DiaWatch, led to significant improvements in metabolic outcomes, including reductions in HbA1c, body weight, blood pressure, and cholesterol levels over an average follow-up of 8 months in 100 patients.

Compared to a control group, the ProEmpower participants showed significantly better improvements in cardiovascular risk factors, highlighting the efficacy of digital technologies in enhancing diabetes management and promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of a digitally supported approach for self-management of type 2 diabetes mellitus. De Luca, V., Bozzetto, L., Giglio, C., et al.[2023]

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]

Mobile health (m-Health) applications can effectively support self-management programs for weight management by helping users monitor their behaviors and engage in lifestyle changes.

These applications are essential tools in addressing obesity, which is primarily caused by overeating and lack of exercise, by providing consumers with resources to manage their weight effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Applications: A Tool for Behaviour Change in Weight Management. Vlahu-Gjorgievska, E., Mulakaparambil Unnikrishnan, S., Win, KT.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12304840/

The mLIFE randomized trial examining the impact of ... The mLIFE study empirically tested whether using points to promote social support led to greater weight loss than the same intervention without ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003185

Protocol of a remote behavioral weight loss randomized ... The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/oby.24330

The mLIFE randomized trial examining the impact of ... The Mobile Lifestyle Intervention for Food and Exercise (mLIFE) study was a 12-month mobile weight loss intervention examining social gaming to promote social ...

4. clinicaltrial.be clinicaltrial.be/en/details/34961?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

The Mobile Lifestyle Intervention for Food and Exercise S... The standard mLIFE app has the ability to send others encouragement ("likes/thumbs-up") for achieving goals and a user-to-user messaging system ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40629523/

The mLIFE randomized trial examining the impact of gamifying ... The Mobile Lifestyle Intervention for Food and Exercise (mLIFE) study was a 12-month mobile weight loss intervention examining social gaming to promote social ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9377471/

Diabetes Self-management Apps: Systematic Review of ... Effective self-management of the condition improves diabetes control, reduces the risk of complications, and improves patient outcomes. Mobile apps for diabetes ...

7. withpower.com withpower.com/trial/phase-overweight-3-2022-ce115

Digital Weight Loss Intervention for Obesity and Type 2 Diabetes ... The mLIFE app treatment is unique because it incorporates self-regulation and social support features to help users manage their weight and reduce the risk of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12480833/

The effects of mobile health on self-management ... A novel mobile health (mHealth) intervention intends to assist diabetics in managing the levels of their blood sugar and improving self-care.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05893927

Impact of a Diabetes Education Mobile Web Application on ... The main question to answer is: Does the use of the Diabetes Application significantly affect clinical outcomes of diabetes and cardiometabolic risk factors ( ...