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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes in patients with overweight and obesity. This study will involve a 6-month long commitment where participants will be expected to use an mHealth app daily, weigh themselves and check their fasting blood glucose levels every morning.

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 data supports the effectiveness of the treatment Healthi, Mobile Health Applications, mHealth Apps for weight management in obesity?

Research shows that mobile health (mHealth) interventions can lead to weight loss outcomes similar to in-person treatments, with studies reporting average weight loss ranging from about 2 kg to 7 kg over various periods. These apps help with self-monitoring, goal setting, and providing feedback, which are important for weight management. ^{1 2 3 4 5}

Is the Mobile Health App for Weight Management safe for humans?

The research does not provide specific safety data for the Mobile Health App for Weight Management, but it highlights user satisfaction and the app's usefulness in managing diet and weight, suggesting it is generally well-received by participants. ^{1 3 6 7 8}

How is the treatment Healthi different from other weight management treatments?

Healthi, a mobile health app, is unique because it allows users to self-manage their weight by monitoring their behavior and engaging in lifestyle changes through their smartphones. Unlike traditional treatments, it provides real-time feedback and support, making it more accessible and adaptable to individual needs. ^{1 5 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Adoption and Appropriateness of mHealth for Weight Management in the Real World: A Qualitative Investigation of Patient Perspectives. [2022]

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

A Systematic Review of Application and Effectiveness of mHealth Interventions for Obesity and Diabetes Treatment and Self-Management. [2023]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Obesity and outpatient rehabilitation using mobile technologies: the potential mHealth approach. [2022]

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

Innovations in the Use of Interactive Technology to Support Weight Management. [2019]

6. China pubmed.ncbi.nlm.nih.gov

Longitudinal evaluation of an mHealth overweight and obesity management tool. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based diet game for weight control. [2019]

8. Canada 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. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

mHealth Applications: A Tool for Behaviour Change in Weight Management. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Mobile applications for obesity and weight management: current market characteristics. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Health Applications in Weight Management: A Systematic Literature Review. [2020]