Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
NCT ID: NCT03288207
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
325 participants
INTERVENTIONAL
2018-06-21
2026-03-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 2 Label: PA monitor with standard remote coaching (SRC)
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Step it Up mobile app
Step it Up mobile app
Global Positioning System (GPS) Device
Global Positioning System (GPS) Device
Bluetooth-enabled scale
Bluetooth-enabled scale
Bluetooth-enabled glucometer
Bluetooth-enabled glucometer
MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH)
Image Reconstruction and Analysis Software
MRI: Research pulse sequences (Device Manufacturer: NIH)
pulse sequences
MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.)
radiofrequency coils
AMRA Researcher Image reconstruction software
Image reconstruction software
Group 1 Label: PA monitor with remote coaching tailored to place
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Step it Up mobile app
Step it Up mobile app
Global Positioning System (GPS) Device
Global Positioning System (GPS) Device
Bluetooth-enabled scale
Bluetooth-enabled scale
Bluetooth-enabled glucometer
Bluetooth-enabled glucometer
MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH)
Image Reconstruction and Analysis Software
MRI: Research pulse sequences (Device Manufacturer: NIH)
pulse sequences
MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.)
radiofrequency coils
AMRA Researcher Image reconstruction software
Image reconstruction software
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Step it Up mobile app
Step it Up mobile app
Global Positioning System (GPS) Device
Global Positioning System (GPS) Device
Bluetooth-enabled scale
Bluetooth-enabled scale
Bluetooth-enabled glucometer
Bluetooth-enabled glucometer
MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH)
Image Reconstruction and Analysis Software
MRI: Research pulse sequences (Device Manufacturer: NIH)
pulse sequences
MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.)
radiofrequency coils
AMRA Researcher Image reconstruction software
Image reconstruction software
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must be an African-American female
* Must be within the age of 21-75 years old
* Must be overweight or obese (Body Mass Index (BMI) \>= 25 kg/m\^2)
* Must live in Washington DC Wards (5, 7, or 8) or live in Prince George s County, Maryland
* Must have a smartphone that is compatible with the study software (mobile app)
* Must be willing to use the software on personal smartphone for the study
* Must be able to provide consent
* Must be willing to wear the wrist-worn physical activity device for the study
* Must not be pregnant
Optional MRI Tests
Subjects will be screened for implanted metal objects or devices that may be incompatible with MRI (i.e. cerebral aneurysm clip, cochlear implant, pacemaker, etc.) These subjects will be eligible to proceed with study enrollment, but will not undergo the optional MRI study.
Exclusion Criteria
* Heart disease as indicated by history of myocardial infarction in past 1 year, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement, within the last year significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy with EF \<35%, severe valvular heart disease) with evidence of decompensation.
* Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. All participants of childbearing potential will need to self-report a negative pregnancy at the screening visit, baseline visit, and at the three-month and six-month visits, unless the participant self-reports being postmenopausal, having had a tubal ligation, or having undergone a complete hysterectomy.
21 Years
75 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
George Washington University
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tiffany M Powell-Wiley, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Boggs DA, Rosenberg L, Cozier YC, Wise LA, Coogan PF, Ruiz-Narvaez EA, Palmer JR. General and abdominal obesity and risk of death among black women. N Engl J Med. 2011 Sep 8;365(10):901-8. doi: 10.1056/NEJMoa1104119.
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
Lightwood J, Bibbins-Domingo K, Coxson P, Wang YC, Williams L, Goldman L. Forecasting the future economic burden of current adolescent overweight: an estimate of the coronary heart disease policy model. Am J Public Health. 2009 Dec;99(12):2230-7. doi: 10.2105/AJPH.2008.152595. Epub 2009 Oct 15.
Troendle JF, Sur A, Leifer ES, Powell-Wiley T. Sensitivity Analyses for Missing in Repeatedly Measured Outcome Data. Stat Med. 2025 Oct;44(23-24):e70282. doi: 10.1002/sim.70282.
Tamura K, Vijayakumar NP, Troendle JF, Curlin K, Neally SJ, Mitchell VM, Collins BS, Baumer Y, Gutierrez-Huerta CA, Islam R, Turner BS, Andrews MR, Ceasar JN, Claudel SE, Tippey KG, Giuliano S, McCoy R, Zahurak J, Lambert S, Moore PJ, Douglas-Brown M, Wallen GR, Dodge T, Powell-Wiley TM. Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity. BMJ Open. 2020 Dec 21;10(12):e040702. doi: 10.1136/bmjopen-2020-040702.
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-H-0162
Identifier Type: -
Identifier Source: secondary_id
170162
Identifier Type: -
Identifier Source: org_study_id