Mobile Health Technology for Obesity

Overseen By Marie Marah, R.N.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Disqualifiers: Heart disease, Physically unable, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

325 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mobile health technology can help African American women increase their exercise levels, potentially lowering the risk of heart disease. Participants will use a smartphone app and a wrist-worn device to track physical activity and receive motivational messages. Some participants may also receive personalized coaching and wireless devices, such as a Bluetooth-enabled glucometer and scale, to monitor health metrics like weight and blood pressure from home. This trial suits African American women who are overweight or obese, live near Washington, DC, and own a compatible smartphone. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve health outcomes for African American women.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that mobile health technology is safe for increasing physical activity?

Research has shown that mobile health technology, such as the Step it Up app, is generally safe for use. Studies on Step it Up, designed to promote physical activity, indicate that users experience no significant issues. In past research, users reported positive experiences and did not encounter major side effects. The app includes features like motivational messages and activity tracking, which users found beneficial.

For Bluetooth-enabled devices, such as scales and GPS trackers, no evidence suggests harm when used correctly. These devices typically monitor weight and location to support healthy lifestyle changes and are often used in health settings, where they are considered safe.

Although these technologies are not FDA-approved for treating specific conditions, they do not pose safety risks when used to encourage exercise. Overall, available data suggests these technologies are safe for increasing physical activity and monitoring health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Step it Up" mobile app because it offers a personalized approach to managing obesity, particularly for African American women in resource-limited communities. Unlike traditional methods like dietary changes and exercise plans, this app combines a physical activity monitor with remote coaching tailored to the individual's environment. This innovative method not only enhances engagement but also adapts to the specific lifestyle and needs of the users, which could lead to more effective and sustainable weight management. By leveraging mobile health technology, the app aims to overcome barriers to traditional healthcare access, making it a promising tool for improving cardiovascular outcomes in at-risk populations.

What evidence suggests that mobile health technology is effective for increasing physical activity in overweight or obese African American women?

Research has shown that mobile health apps like Step it Up, which participants in this trial may use, can help people become more active. A small study found that this app helped Black women in areas with fewer resources stay active. These women experienced improved physical activity levels and heart health. Additionally, using mobile phone apps has been linked to weight loss and a lower Body Mass Index (BMI), both important for heart health. Overall, these findings suggest that using the Step it Up app can be a promising way to increase exercise and improve health. ^{6 7 8 9 10}

Who Is on the Research Team?

Tiffany M Powell-Wiley, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for African American women aged 21-75 who are overweight or obese, live in specific areas near Washington, DC, and have a compatible smartphone. They must be able to consent and willing to use the app and wear a physical activity device. Pregnant women or those with certain medical conditions like heart disease can't join.

Inclusion Criteria

I am an African American woman, aged 21-75, overweight or obese, living in specific areas of DC or MD.

I am an African-American woman.

Ability to provide informed consent independently

Exclusion Criteria

I have a health issue that could make it unsafe for me to join this study.

I cannot perform physical activities due to my condition.

I have a history of heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants answer survey questions, have body size measured, get blood tests, and learn to use the study app and wearable device

1 day

1 visit (in-person)

Initial Data Collection

Researchers collect data on participants' physical activity for 2 weeks

2 weeks

Intervention

Participants receive remote coaching and use mobile health technology to increase physical activity

6 months

Visits at 3 and 6 months (in-person)

Follow-up

Participants are monitored for changes in physical activity and cardiovascular health measures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bluetooth-enabled glucometer
• Bluetooth-enabled scale
• Global Positioning System (GPS) Device
• Step it Up mobile app

Trial Overview The study tests if mobile health technology like apps, wearable devices, and Bluetooth-enabled health monitors can help increase physical activity to reduce obesity and improve cardiovascular health among participants living in resource-limited neighborhoods.

How Is the Trial Designed?

Group I: Group 2 Label: PA monitor with standard remote coaching (SRC) Experimental Treatment 8 Interventions

African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.

Group II: Group 1 Label: PA monitor with remote coaching tailored to place Experimental Treatment 8 Interventions

African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials

3,987

Recruited

47,860,000+

George Washington University

Collaborator

Trials

263

Recruited

476,000+

Published Research Related to This Trial

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]

This study will evaluate the effectiveness of a gamification-based smartphone application for weight loss in overweight and obese adolescents over a 6-month period, involving 108 participants in a randomized controlled trial.

The primary outcome will be the change in body mass index z score, with secondary objectives focusing on adherence and various health-related changes, aiming to provide valuable insights into the potential of digital interventions for weight management in youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial. Timpel, P., Cesena, FHY., da Silva Costa, C., et al.[2022]

Adolescents with overweight have clear insights into their own (un)healthy behaviors and express specific needs for a tailored eHealth application to support their weight loss journey.

Parents often underestimate their influence on their children's behaviors and face challenges in promoting healthy lifestyles, highlighting the need for an app that can assist both adolescents and parents in achieving healthier habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone application as a personalized treatment tool for adolescents with overweight: an explorative qualitative study. Desmet, M., Franssen, S., Varol, T., et al.[2023]

In a 12-week pilot study with 39 participants, all groups using self-monitoring (SM) of food intake, whether with or without real-time feedback (FB) or in-person sessions, achieved significant weight loss, averaging around 3% of their body weight.

Adherence to dietary self-monitoring was similar across all groups, indicating that the addition of real-time feedback or in-person sessions did not significantly enhance adherence or weight loss outcomes, suggesting that self-monitoring alone can be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring. Burke, LE., Zheng, Y., Ma, Q., et al.[2022]

mHealth systems present innovative opportunities for addressing childhood obesity through cost-effective interventions and real-time data collection, but they also face challenges such as a lack of scientific evidence for effectiveness and concerns over data security and privacy.

To maximize the benefits of mHealth in combating childhood obesity, researchers, health practitioners, and policymakers need to collaborate, focusing on developing secure technologies, regulating app quality, and creating effective partnerships between academia and industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. Tate, EB., Spruijt-Metz, D., O'Reilly, G., et al.[2022]

Participants in the SBWL+TECH group, who used a wearable physical activity monitor, increased their moderate-to-vigorous physical activity by 132.9 minutes per week, which was three times greater than the SBWL group, although this difference was not statistically significant.

Both groups experienced modest weight loss, with the SBWL+TECH group losing 10.0% of their body weight compared to 7.8% in the SBWL group, indicating that technology-assisted monitoring may help enhance physical activity levels in severely obese individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. Unick, JL., O'Leary, KC., Bond, DS., et al.[2022]

The ENGAGED study involves 96 obese adults and compares three weight loss methods over 12 months, aiming for a 7% weight loss goal through dietary changes and increased physical activity.

The study hypothesizes that the technology-supported behavioral weight loss program (TECH) will lead to greater weight loss than standard methods (STND) and self-guided approaches (SELF) due to better adherence and goal achievement, utilizing a smartphone app for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. Pellegrini, CA., Duncan, JM., Moller, AC., et al.[2021]

In a 6-month pilot study involving 55 healthy young adults, participants in the overweight-obese group experienced a short-term decrease in BMI but did not maintain this change, indicating challenges in sustaining weight loss and negative feelings associated with social comparison on the app.

Conversely, participants in the underweight-normal BMI group actively engaged with the app's self-monitoring and social features, leading to a significant increase in their daily step count, highlighting the need for personalized interventions to cater to different user experiences and motivations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Social Networking App for Weight Management and Physical Activity Promotion: Results From an Experimental Mixed Methods Study. Laranjo, L., Quiroz, JC., Tong, HL., et al.[2021]

In a study of 833 participants, adding a smartphone app to traditional counselling for diet and physical activity led to significant reductions in waist circumference and body fat percentage in women after 12 months, indicating the app's effectiveness in supporting weight management.

The beneficial effects of the app were not observed in men, suggesting that the intervention may be more effective for women, highlighting the need for tailored approaches in weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study. Gomez-Marcos, MA., Patino-Alonso, MC., Recio-Rodriguez, JI., et al.[2022]

Only half of the behavior change techniques (BCTs) are implemented in the analyzed mHealth apps targeting obesity in young people, indicating a significant gap in their potential effectiveness.

The study proposes design guidelines that link BCTs with user interface design patterns (UIDPs) to enhance the usability and impact of mHealth apps, aiming to improve long-term user engagement and behavior change among adolescents aged 10-24.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Apps Targeting Obesity and Overweight in Young People: App Review and Analysis. Vlahu-Gjorgievska, E., Burazor, A., Win, KT., et al.[2023]

This study will evaluate the effectiveness of a smartphone application for reducing obesity in adolescents over 12 months, comparing it to a traditional family-based lifestyle intervention called W82GO, involving 134 participants.

The primary outcome will be the change in body mass index (BMI) standardized deviation score, along with secondary outcomes like waist circumference and quality of life, providing valuable insights into mobile health solutions for managing adolescent obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. O'Malley, G., Clarke, M., Burls, A., et al.[2022]

In a 12-month study involving 70 adults with obesity, the group using mobile technology for self-monitoring and coaching lost an average of 3.9 kg more than the standard treatment group, indicating enhanced weight loss efficacy.

Participants in the mobile technology group had significantly higher odds (6.5 times greater) of losing at least 5% of their baseline weight compared to those receiving standard care alone, suggesting that mobile technology can effectively support weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating technology into standard weight loss treatment: a randomized controlled trial. Spring, B., Duncan, JM., Janke, EA., et al.[2021]

A systematic review of 55 randomized controlled trials involving 3406 records found that technology-based interventions for treating pediatric obesity resulted in a small but significant weight loss effect (effect size d = -0.13), although many studies did not show significant differences compared to control groups.

In contrast, prevention interventions using technology did not demonstrate a significant impact on weight outcomes, indicating that more research is needed to assess their effectiveness compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing technological solutions for childhood obesity prevention and treatment: a systematic review and meta-analysis of current applications. Fowler, LA., Grammer, AC., Staiano, AE., et al.[2023]

The Health-On mobile technology-based weight control program led to a significant average weight reduction of 5.8% among 30 obese participants over a 12-week period, indicating its efficacy in weight management.

Participants also showed significant improvements in various metabolic profiles and fat measures, such as blood pressure and cholesterol levels, suggesting that the program not only aids in weight loss but also enhances overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile-Based Comprehensive Weight Reduction Program for the Workplace (Health-On): Development and Pilot Study. Han, MK., Cho, B., Kwon, H., et al.[2020]

Citations

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2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9680010/

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Use of Mobile Phone App Interventions to Promote Weight Loss Mobile phone apps were associated with significant weight loss (-1.07 kg) and BMI reduction (-0.45 kg/m2) compared to control groups.

5. researchgate.net researchgate.net/publication/224120282_StepUp_A_step_counter_mobile_application_to_promote_healthy_lifestyle

A step counter mobile application to promote healthy lifestyle In this paper, we present the design, implementation, and evaluation of the StepUp application a step counter application. StepUp exploits off-the-shelf sensor- ...

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7. fda.gov fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication

Do Not Use Smartwatches or Smart Rings to Measure ... The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8212630/

Mobile and Wearable Technology for the Monitoring of ... This study aims to review the literature on the use of modern mobile and wearable technology for monitoring parameters that condition the development or ...

9. diabetesjournals.org diabetesjournals.org/care/article/46/5/959/148541/An-Integrated-Digital-Health-Care-Platform-for

An Integrated Digital Health Care Platform for Diabetes ... We investigated the efficacy of an integrated digital health care platform with artificial intelligence (AI)–based dietary management in adults with type 2 ...

10. uchealth.org uchealth.org/today/diabetes-remote-monitoring-program-helps-patients-manage-dangerous-disease/

Diabetes remote monitoring program helps manage disease The UCHealth Virtual Health Center uses technology and coaching to help Type 2 diabetes patients manage their blood sugar levels.