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 Obesity and physical inactivity contribute substantially to cardiovascular disease risk, diabetes, hypertension, and dyslipidemia. African American women experience disproportionately high rates of obesity and have among the lowest levels of physical activity and greatest sedentary time in the United States. Resource-limited neighborhoods may further constrain physical activity through limited access to safe parks, recreation facilities, walking routes, and other health-promoting resources. This protocol builds on prior community-based work in Washington, D.C., which demonstrated the feasibility of wearable activity monitoring among predominantly African American women in faith-based, lower-resource communities. It uses community-based participatory research principles and mobile health technology to deliver physical-activity coaching tailored either to individual factors or to available neighborhood resources. Objectives Primary objective To determine whether initiating an adaptive physical-activity intervention with remote, mobile-app coaching tailored to neighborhood physical-activity resources "tailored-to-place" coaching-produces a greater increase in steps per day over approximately three months than standard remote coaching. Secondary objectives The study will also: Compare four embedded adaptive intervention strategies over approximately six months. Assess the feasibility of remotely measuring weight, blood pressure, and blood glucose using connected devices. Evaluate effects on cardiometabolic measures, including BMI, blood pressure, lipids, glucose, dietary intake, self-reported physical activity, and smoking. Examine inflammatory, lipid, immunometabolic, psychosocial, behavioral, and social-determinants-of-health pathways related to physical-activity change. Evaluate changes in cardiac structure and function and body composition using optional cardiovascular and body-composition MRI. Assess relationships among sleep, ambulatory blood pressure, menopause-related factors, and immunometabolic markers in a postmenopausal sleep sub-study. Conduct user-centered testing of the mobile application and wearable/mobile health technologies. Explore COVID-19 exposure and pandemic-related psychosocial stress as potential confounders of immunologic and psychosocial outcomes. Eligibility: Inclusion Criteria Participants must: Be African American women aged 21-75 years. Have overweight or obesity, defined as BMI \>=25 kg/m\^2 Live in Washington, D.C., Wards 5, 7, or 8, or in neighboring areas of Prince George's County, Maryland. Have access to a smartphone compatible with the study application. Be able to provide informed consent independently. Speak and read English at approximately an eighth-grade level. Participants enter a two-week run-in period. Those averaging 7,500 steps per day or fewer and who complete the run-in are eligible for randomization into the intervention. Main study exclusion criteria Potential participants are excluded for conditions that could make increased physical activity unsafe or interfere with study assessments, including: Medical conditions or physical limitations that prohibit safe participation in physical activity. Recent myocardial infarction, documented obstructive coronary artery disease, recent coronary stenting, or significant decompensated structural heart disease. Pregnancy; pregnancy status is assessed as applicable during study visits. Other conditions determined by the investigator to make participation unsafe. Sleep sub-study eligibility The optional sleep sub-study is limited to postmenopausal women who are enrolled in or have completed the main study. Additional exclusions include night-shift work, conditions that interfere with overnight polysomnography, recent initiation of sleep-modifying medications, inability to tolerate ambulatory blood-pressure monitoring, and certain arm, vascular, skin, bleeding, or neurologic conditions. MRI participation is optional and requires separate screening for MRI-incompatible implanted devices or metal and, when applicable, eligibility for gadolinium contrast. Study design A six-month adaptive randomized trial will enroll overweight or obese African American women. After a two-week run-in, participants averaging \<=7,500 steps/day will receive either standard mobile-app coaching or coaching tailored to neighborhood physical-activity resources. At three months, nonresponders will be reassigned to intensified coaching. Steps will be measured with a wearable device, with assessments at baseline, three months, and six months. Optional monitoring and MRI/sleep sub-studies will assess cardiometabolic outcomes....
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, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 4, 2027
October 2, 2026
September 17, 2026
9.1 years
September 19, 2017
October 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in physical activity, measured as average steps per day
Compare the change in objectively measured daily step counts between participants initially assigned to remote coaching tailored to neighborhood physical-activity resources (tailored-to-place coaching) and those assigned to standard remote coaching. Steps are captured by a wrist-worn physical-activity monitor and summarized as average steps per day. The protocol's primary treatment effect is based on the average weekly step counts during the final four weeks of the six-month intervention, approximately weeks 21-24 for the longer-term adaptive intervention analysis.
Baseline/run-in through approximately 3 months after randomization
Secondary Outcomes (10)
Cardiac structure, function, and perfusion
Optional CMR during the run-in/baseline period and again within the month-6 visit window
Mobile-health technology feasibility and acceptability
Pilot period of approximately 23 days; intervention period up to approximately 6.5 months
Psychosocial and behavioral mediators
Baseline, approximately 3 months, and approximately 6 months
Inflammatory and immunometabolic biomarkers
Baseline, approximately 3 months, and approximately 6 months
Cardiometabolic health factors
Baseline, approximately 3 months, and approximately 6 months
- +5 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
pulse sequences
Provides SRC components plus recommendations based on physical-activity resources near the participant s home, work, or church. Messages may recommend parks, recreation centers, exercise classes, trails, greenspaces, or walking routes within an approximately 0.75-mile radius.
Provides individual-level physical-activity coaching based on goal setting, self-efficacy, barriers, personal preferences, and step data. Educational content is adapted from the Diabetes Prevention Program. Messaging encourages progression toward 10,000 steps/day.
Measures systolic and diastolic blood pressure and pulse over approximately 48 hours during usual daily activities.
Overnight monitoring using EEG, EOG, EMG, ECG, respiratory airflow and effort, oxygen saturation, body position, snoring, and leg-movement sensors to characterize sleep, including slow-wave sleep.
Image reconstruction software
Participants self-monitor activity during an approximately 2-week run-in period without receiving intervention messaging. Participants averaging 7,500 steps/day proceed to randomization.
Bluetooth-enabled glucometer
Image Reconstruction and Analysis Software
radiofrequency coils
Eligibility Criteria
You may qualify if:
- Individuals eligible for this protocol have overweight or obesity (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 have overweight or obesity (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
- Eligibility for Post-Menopausal Status for Sleep Sub-study:
- Eligibility is limited to post-menopausal women who have either completed or are currently enrolled in the main study. Confirmation of post-menopausal status will be determined by review of medical history prior to final eligibility assessment for the study. In patients with prior hysterectomy and retained ovaries, menopause cannot be diagnosed using menstrual criteria. Diagnosis will be made clinically based on age consistent with natural menopause ( \>=45) and the presence of menopausal symptoms, such as vasomotor or genitourinary symptoms.
- Additionally, participants will not be eligible for the optional Sleep Sub-study if:
- +7 more criteria
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, 2027
Study Completion (Estimated)
August 4, 2027
Last Updated
October 2, 2026
Record last verified: 2026-09-17