Mobile Health Technology for Obesity

Overseen by Tiffany M Powell-Wiley, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Disqualifiers: Heart disease, Physically unable, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Background: Heart disease is a leading cause of death. People can reduce their heart disease risk by exercising more. Mobile health technology may make people more successful at increasing their exercise. This includes things like physical activity monitors and smartphone apps. Objective: To find out if mobile health technology can increase physical activity. Eligibility: African American women ages 21-75 who: * Are overweight or obese * Live in certain areas near Washington, DC * Have a smartphone that can use the study app Design: At visit 1, participants will * Answer survey questions. These may be about medical history, physical activity, and weight. They may also cover body image, health perception, and spirituality. * Have body size measured and get blood tests * Get a device to wear on the wrist. It will record physical activity and hours of sleep. * Learn how to download and use the study mobile app For 2 weeks, researchers will collect data about participants physical activity. Then participants will have a study visit with additional blood tests. All participants will get messages from the app that encourage exercise. Some participants will get data from the app about exercise near their home or work. Some participants may get face-to-face coaching. Participants may get wireless devices. These measure body weight, blood pressure, and blood glucose. Participants can measure these at home and upload the data to the app for the study. Participants will have visits after 3 and 6 months. They will repeat the visit 1 tests.

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 data supports the effectiveness of the treatment Mobile Health Technology for Obesity?

Research suggests that mobile health technologies, like smartphone apps and fitness trackers, can help with weight management by increasing compliance and reducing the need for in-person visits, making weight loss programs more accessible and cost-effective. ^{1 2 3 4 5}

Is mobile health technology for obesity generally safe for humans?

The research suggests that mobile health technologies, like wearable activity monitors and smartphone apps, are generally safe for use in weight loss programs. However, there are concerns about data security, privacy, and potential increased screen time, which should be considered. ^{3 6 7 8 9}

How is the Step it Up mobile app treatment for obesity different from other treatments?

The Step it Up mobile app is unique because it leverages mobile health technology to support weight loss, offering a convenient and accessible way to manage obesity through a smartphone. Unlike traditional treatments, it provides a personalized and engaging approach, which is particularly appealing to younger users who are accustomed to using mobile devices in their daily lives. ^{10 11 12 13 14}

Research Team

Tiffany M Powell-Wiley, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

A Mobile Social Networking App for Weight Management and Physical Activity Promotion: Results From an Experimental Mixed Methods Study. [2021]

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

Harnessing technological solutions for childhood obesity prevention and treatment: a systematic review and meta-analysis of current applications. [2023]

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

Integrating technology into standard weight loss treatment: a randomized controlled trial. [2021]

5. 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]

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

The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring. [2022]

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

mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]

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

Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. [2022]

9. United States 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. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

A Mobile-Based Comprehensive Weight Reduction Program for the Workplace (Health-On): Development and Pilot Study. [2020]

11. England 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. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

mHealth Apps Targeting Obesity and Overweight in Young People: App Review and Analysis. [2023]

13. England pubmed.ncbi.nlm.nih.gov

A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

A smartphone application as a personalized treatment tool for adolescents with overweight: an explorative qualitative study. [2023]