Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
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.
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.
346812What 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.
12101112How 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.
5791314Do 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.
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.
My BMI is 25 or higher, indicating I am overweight or obese.
I am between 21 and 75 years old.
Exclusion Criteria
I cannot perform physical activities due to my condition.
I have a history of heart disease.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Group 2 Label: PA monitor with standard remote coaching (SRC)Experimental Treatment4 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 placeExperimental Treatment4 Interventions
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
George Washington UniversityCollaborator
References
A smartphone-supported weight loss program: design of the ENGAGED randomized controlled trial. [2021]Obesity remains a major public health challenge, demanding cost-effective and scalable weight management programs. Delivering key treatment components via mobile technology offers a potential way to reduce expensive in-person contact, thereby lowering the cost and burden of intensive weight loss programs. The ENGAGED study is a theory-guided, randomized controlled trial designed to examine the feasibility and efficacy of an abbreviated smartphone-supported weight loss program.
Integrating technology into standard weight loss treatment: a randomized controlled trial. [2021]A challenge in intensive obesity treatment is making care scalable. Little is known about whether the outcome of physician-directed weight loss treatment can be improved by adding mobile technology.
mHealth approaches to child obesity prevention: successes, unique challenges, and next directions. [2022]Childhood obesity continues to be a significant public health issue. mHealth systems offer state-of-the-art approaches to intervention design, delivery, and diffusion of treatment and prevention efforts. Benefits include cost effectiveness, potential for real-time data collection, feedback capability, minimized participant burden, relevance to multiple types of populations, and increased dissemination capability. However, these advantages are coupled with unique challenges. This commentary discusses challenges with using mHealth strategies for child obesity prevention, such as lack of scientific evidence base describing effectiveness of commercially available applications; relatively slower speed of technology development in academic research settings as compared with industry; data security, and patient privacy; potentially adverse consequences of increased sedentary screen time, and decreased focused attention due to technology use. Implications for researchers include development of more nuanced measures of screen time and other technology-related activities, and partnering with industry for developing healthier technologies. Implications for health practitioners include monitoring, assessing, and providing feedback to child obesity program designers about users' data transfer issues, perceived security and privacy, sedentary behavior, focused attention, and maintenance of behavior change. Implications for policy makers include regulation of claims and quality of apps (especially those aimed at children), supporting standardized data encryption and secure open architecture, and resources for research-industry partnerships that improve the look and feel of technology. Partnerships between academia and industry may promote solutions, as discussed in this commentary.
Physical activity enhancement to a behavioral weight loss program for severely obese individuals: A preliminary investigation. [2022]Severe obesity is characterized by low physical activity (PA) and interventions to enhance PA are needed. Participants (45.0 ± 3.9 kg/m2) were randomized to a 6-month standard behavioral weight loss program (SBWL; n = 14) or SBWL+technology (SBWL+TECH; n = 15). Both groups received identical SBWL treatment and SBWL+TECH also received a wearable PA monitor, providing "real-time" feedback, and website access to monitor energy balance. 6-month retention was similar between groups (SBWL: 12/13 versus SBWL+TECH: 11/14 completers; P = 0.19) and adherence to wearing the armband was excellent (91.3% of days). Although differences in PA between groups did not meet conventional thresholds of significance, SBWL+TECH increased their moderate-to-vigorous intensity PA by 132.9±216.8 min/week, which was 3 times greater than SBWL (44.8±124.3 min/week; P = 0.27; Cohen's d = 0.50). There was a trend for SBWL+TECH to self-monitor for a greater proportion of days compared to SBWL (86.2±21.4% versus 71.5±19.4%; P = 0.098; Cohen's d = 0.72). The difference in weight loss between groups was modest (SBWL+TECH: -10.0 ± 7.1% versus SBWL: -7.8 ± 6.7%; P = 0.46). These preliminary findings suggest that PA monitors may be one strategy for increasing PA among the severely obese. Larger, long-term trials are needed.
A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial. [2022]There are few evidence-based mobile health solutions for treating adolescent obesity. The primary aim of this parallel non-inferiority trial is to assess the effectiveness of an experimental smartphone application in reducing obesity at 12 months, compared to the Temple Street W82GO Healthy Lifestyles intervention.
The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring. [2022]Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1-4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and SM + FB + attending three in-person group sessions (Group 3). The sample (N = 39) was mostly white and female with a mean body mass index of 33.76 kg/m2. Adherence to dietary SM was recorded daily, weight was assessed at baseline and 12 weeks. The mean percentage of days adherent to dietary SM was similar among Groups 1, 2, and 3 (p = 0.66) at 53.50% vs. 55.86% vs. 65.33%, respectively. At 12 weeks, all groups had a significant percent weight loss (p < 0.05), with no differences among groups (- 2.85% vs. - 3.14% vs. - 3.37%) (p = 0.95); 26% of the participants lost ≥ 5% of their baseline weight. Mean retention was 74% with no differences among groups (p = 0.37). All groups adhered to SM at levels comparable to or better than other weight loss studies and lost acceptable amounts of weight, with minimal intervention contact over 12 weeks. These preliminary findings suggest this 3-group approach testing SM alone vs. SM with real-time FB messages alone or supplemented with limited in-person group sessions warrants further testing in a larger, more diverse sample and for a longer intervention period.
Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomised clinical trial - EVIDENT II study. [2022]Evidence on the efficacy of smartphone applications (apps) for reducing body weight and other measurements of adiposity sustainably is not conclusive.
Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months.
A Mobile-Based Comprehensive Weight Reduction Program for the Workplace (Health-On): Development and Pilot Study. [2020]There is a growing interest in mobile technology for obesity management. Despite the known effectiveness of workplace-based weight loss programs, there are few studies on mobile phone-delivered interventions.
Formative Evaluation of a Smartphone App for Monitoring Daily Meal Distribution and Food Selection in Adolescents: Acceptability and Usability Study. [2021]Obesity interventions face the problem of weight regain after treatment as a result of low compliance. Mobile health (mHealth) technologies could potentially increase compliance and aid both health care providers and patients.
A Mobile Social Networking App for Weight Management and Physical Activity Promotion: Results From an Experimental Mixed Methods Study. [2021]Smartphone apps, fitness trackers, and online social networks have shown promise in weight management and physical activity interventions. However, there are knowledge gaps in identifying the most effective and engaging interventions and intervention features preferred by their users.
Harnessing technological solutions for childhood obesity prevention and treatment: a systematic review and meta-analysis of current applications. [2023]Technology holds promise for delivery of accessible, individualized, and destigmatized obesity prevention and treatment to youth.
mHealth Apps Targeting Obesity and Overweight in Young People: App Review and Analysis. [2023]Overweight and obesity have been linked to several serious health problems and medical conditions. With more than a quarter of the young population having weight problems, the impacts of overweight and obesity on this age group are particularly critical. Mobile health (mHealth) apps that support and encourage positive health behaviors have the potential to achieve better health outcomes. These apps represent a unique opportunity for young people (age range 10-24 years), for whom mobile phones are an indispensable part of their everyday living. However, despite the potential of mHealth apps for improved engagement in health interventions, user adherence to these health interventions in the long term is low.
A smartphone application as a personalized treatment tool for adolescents with overweight: an explorative qualitative study. [2023]The present study is the first step of a 3-year European project in which a tailored smartphone application will be developed and tested as a potential tool in the personalized treatment of children and adolescents with overweight.