Mobile Health App for Weight Management in Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Must not be taking: Antipsychotics, Antidepressants, Steroids

Disqualifiers: Diabetes medications, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a mobile app in helping individuals with overweight or obesity manage their weight. Participants will use an app called Healthi daily for six months, tracking their weight and fasting blood sugar levels each morning. The study includes a control group that does not use the app, enabling researchers to compare outcomes. This trial is suitable for individuals with a BMI of 25 or higher who own a smartphone and a bathroom scale. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance weight management strategies.

Will I have to stop taking my current medications?

If you are taking medications that promote weight gain, like certain antipsychotics, antidepressants, or steroid hormones, you may need to stop them to join the trial. However, diabetes medications like insulin, thiazolidinediones, or sulfonylureas are allowed.

What prior data suggests that this mobile health app is safe for weight management?

Research has shown that mobile health apps, such as Healthi, are generally safe and user-friendly. Studies on similar weight management apps indicate they can aid in weight loss and health improvement without causing harm. Most studies reported no serious negative effects, suggesting that using an app like Healthi carries low risk. This trial focuses on the app's effectiveness in helping users achieve weight management goals, rather than on safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Healthi because it's a mobile health app that offers a fresh approach to weight management in obesity. Unlike traditional treatments that often include medication or dietary guidelines, Healthi leverages technology to provide personalized support and real-time feedback. This app empowers users by tracking their progress, offering tailored advice, and fostering a sense of community, which can enhance motivation and adherence. By integrating these unique features, Healthi has the potential to make weight management more accessible and engaging for individuals struggling with obesity.

What evidence suggests that this mobile health app is effective for weight management in obesity?

Research has shown that mobile health apps can help people lose weight if they are overweight or obese. In this trial, participants will use the Healthi app to study its effectiveness in weight management. One study found that using a popular health app helped users lose 5% of their body weight in six months. Another study showed that about 42% of active app users lost at least 5% of their body weight after a year. These apps are generally easy to use and effective for reaching weight loss goals. Overall, mobile health apps appear to be a promising tool for managing obesity. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 who are overweight or obese (BMI ≥ 25), own a smartphone, and have access to a bathroom scale. It's not suitable for those on medications that affect weight like certain diabetes treatments or drugs that promote weight gain such as antipsychotics, antidepressants, and steroids.

Inclusion Criteria

Owns a smartphone and willing to download mobile app

Between the age of 18-64

Your body mass index (BMI) is 25 or higher, which means you are overweight.

Exclusion Criteria

If you have diabetes, you are allowed to take insulin, thiazolidinediones, or sulfonylureas medication during the trial.

You are taking medications that can cause weight gain, such as drugs for mental health or hormones.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use an mHealth app daily, weigh themselves, and check fasting blood glucose levels every morning

6 months

Follow-up

Participants are monitored for changes in diabetes, body weight, quality of life, and self-efficacy in weight management

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthi

Trial Overview

The study tests the effectiveness of an mHealth app called Healthi in managing weight over six months. Participants will use the app daily, track their weight each morning, and monitor fasting blood glucose levels.

How Is the Trial Designed?

Group I: Healthi Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

In a study involving 24 veterans, it was found that while most participants believed mHealth interventions for weight management were appropriate, many did not complete the registration process, indicating that initial adoption requires more than just a single invitation.

Key barriers to mHealth adoption included preferences for in-person care and challenges with self-monitoring, suggesting that successful implementation should consider user preferences and provide multiple options for engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoption and Appropriateness of mHealth for Weight Management in the Real World: A Qualitative Investigation of Patient Perspectives. Breland, JY., Agha, K., Mohankumar, R.[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]

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]

In a study of 940 adult users of the DrHolmApp, 71% experienced a reduction in body mass index (BMI), with an average decrease of 0.63 BMI points, indicating the app's effectiveness in promoting weight loss.

Users also reported significant improvements in physical activity, mood, quality of life, and body image satisfaction, suggesting that the app not only aids in weight loss but also enhances overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal evaluation of an mHealth overweight and obesity management tool. Langkjær, IOJ., Fonvig, CE., Holm, LA., et al.[2022]

Mobile health apps are effective tools for facilitating weight management, as they help users adhere to treatment plans through self-monitoring and engagement, leading to successful weight loss and maintenance.

A systematic review of 39 studies published between 2012 and 2017 found that users generally find these apps satisfactory and easy to use, highlighting the importance of high engagement levels for achieving weight loss goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Applications in Weight Management: A Systematic Literature Review. Dounavi, K., Tsoumani, O.[2020]

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]

A systematic review of 24 mHealth studies on obesity and diabetes treatment showed that over 50% reported positive outcomes, including weight loss and blood glucose reduction, indicating the potential effectiveness of mobile technologies in managing chronic diseases.

Despite promising results, most studies had small sample sizes and short intervention durations, highlighting the need for future research with larger groups and longer follow-up periods to better assess the long-term efficacy of mHealth interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. Wang, Y., Xue, H., Huang, Y., et al.[2023]

Current mobile health (mHealth) technologies have the potential to significantly enhance real-time interventions for obesity-related behaviors, but most efforts still rely on basic SMS interventions instead of utilizing advanced real-time sensing capabilities.

The paper highlights five studies that explore innovative uses of new technologies for monitoring diet, physical activity, and sleep, while also addressing the challenges that mHealth obesity research must overcome to fully leverage these advancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in the Use of Interactive Technology to Support Weight Management. Spruijt-Metz, D., Wen, CK., O'Reilly, G., et al.[2019]

The mHealth system, which included a smartphone app and external sensors, was found to be highly acceptable and usable among 26 high school students, receiving a 'Good' grade of 77.1 on the System Usability Scale.

Participants showed increased compliance in recording their dietary habits, with meal registration frequency rising from 70% in the first week to 76% in the second week, indicating that the system could effectively help monitor dietary habits in real life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative Evaluation of a Smartphone App for Monitoring Daily Meal Distribution and Food Selection in Adolescents: Acceptability and Usability Study. Langlet, B., Maramis, C., Diou, C., et al.[2021]

The study identified 28,905 weight-management apps across various platforms, highlighting the popularity of mobile health (mHealth) solutions for addressing overweight and obesity, with a focus on physical activity (34%) and diet (31%).

Despite the abundance of these apps, only 17 (0.05%) included identifiable professional input from dietitians or nutritionists, indicating a significant gap in expert content that could enhance their effectiveness and safety for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile applications for obesity and weight management: current market characteristics. Nikolaou, CK., Lean, ME.[2018]

The SmartDiet mobile application effectively helped participants lose weight and improve body composition, with significant reductions in fat mass, weight, and body mass index observed in the intervention group of 19 people over a six-week period.

User satisfaction was high, as most participants found the app useful for obtaining dietary information and managing their diet, indicating its potential as a valuable tool for weight management in obese adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based diet game for weight control. Lee, W., Chae, YM., Kim, S., et al.[2019]

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