Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
2 other identifiers
interventional
325
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Jun 2018
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedStudy Start
First participant enrolled
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 4, 2026
April 22, 2026
April 20, 2026
8.1 years
September 19, 2017
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The difference in physical activity (PA) change between an adaptive intervention with remote coaching tailored to neighborhood resources (referred to as tailored-to-place coaching) versus beginning w/ standard remote coaching
The difference in physical activity (PA) change (as measured by steps/day) by beginning an adaptive intervention with remote coaching tailored to neighborhood resources (referred to as tailored-to-place coaching) versus beginning with standard remote coaching.
baseline, and up to 6 months
Secondary Outcomes (7)
Measure exposure to COVID-19 and psychosocial stress caused by the pandemic
Up to 6 months
Examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health
Up to 6 months
Identify potential novel inflammatory pathways linked to cardiometabolic risk phenotypes
Up to 6 months
Examine the effect of an adaptive community-based intervention targeting Physical Activity on Cardiovascular health measures
Up to 6 months
Examine the feasibility of incorporating methods for remote capture of CV health measures
Up to 6 months
- +2 more secondary outcomes
Study Arms (2)
Group 2 Label: PA monitor with standard remote coaching (SRC)
OTHERAfrican American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Group 1 Label: PA monitor with remote coaching tailored to place
OTHERAfrican American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Interventions
Step it Up mobile app
Global Positioning System (GPS) Device
Bluetooth-enabled scale
Bluetooth-enabled glucometer
Image Reconstruction and Analysis Software
pulse sequences
radiofrequency coils
Image reconstruction software
Eligibility Criteria
You may qualify if:
- Individuals eligible for this protocol are overweight or obese (BMI \>= 25 kg/m\^2) African American women aged 21-75 years who live in Washington, DC Wards 5,7, or 8 and neighboring areas of Prince George s County, MD. Eligible participants should also have access to a smartphone compatible with the mobile app for the protocol that they can use for the study. Eligible participants must be able to provide informed consent independently and also speak and read English at the 8th grade level.
You may not qualify if:
- Medical condition, including heart failure, recent unintentional weight loss or physical limitation, that might prohibit safe participation in physical activity for any reason
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (5)
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.
PMID: 26811276BACKGROUNDBoggs 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.
PMID: 21899451BACKGROUNDLightwood 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.
PMID: 19833999BACKGROUNDTroendle 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.
PMID: 41057147DERIVEDTamura 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.
PMID: 33371027DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany M Powell-Wiley, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2017
First Posted
September 20, 2017
Study Start
June 21, 2018
Primary Completion (Estimated)
August 4, 2026
Study Completion (Estimated)
August 4, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04-20