Maßgeschneiderte mobile Gesundheitstechnologie zur Reduzierung von Fettleibigkeit und Verbesserung der kardiovaskulären Gesundheit in Nachbarschaftsumgebungen mit begrenzten Ressourcen
Maßgeschneiderte mobile Gesundheitstechnologie zur Reduzierung von Fettleibigkeit und Verbesserung der kardiovaskulären Gesundheit in ressourcenbegrenzten Nachbarschaftsumgebungen: Eine mehrstufige, gemeinschaftsbasierte Intervention für körperliche Aktivität
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Gerät: AMRA(r) Researcher Image reconstruction software
- Gerät: MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.)
- Gerät: MRI: Research pulse sequences (Device Manufacturer: NIH)
- Gerät: MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH)
- Gerät: Bluetooth-enabled glucometer
- Gerät: Remote tailored-to-place coaching (TPC)
- Sonstiges: Standard remote coaching (SRC)
- Gerät: Run-in physical-activity monitoring
- Gerät: Ambulatory blood-pressure monitor
- Gerät: Polysomnography equipment
Detaillierte Beschreibung
Targeted, effective behavioral interventions are critically needed to ameliorate the disproportionate prevalence of poor cardiometabolic health for African American women. We propose a sequential, multiple-assignment, randomized trial targeting physical activity (PA) among at-risk African American women in resource-limited, Washington, D.C. communities using mobile health (mHealth) technology. We hypothesize that by beginning a community-based, adaptive PA intervention with remote coaching tailored to neighborhood environment PA resources, we will see greater increases in PA levels as compared to standard remote coaching. In Aim 1, we will determine if beginning an adaptive intervention with remote coaching tailored to neighborhood environment resources and delivered using mHealth technology (wearables and mobile applications) will lead to a greater PA increase (as measured by steps per day) as compared to standard remote coaching. In Aim 2, we will examine which of four embedded adaptive interventions produce the largest PA increase over the six-month study period. In Aim 3, we will evaluate the feasibility of remote capture of cardiometabolic measures, including blood pressure, weight, and glucose, using mHealth technology. We will also examine intervention effects on cardiometabolic health (adiposity, blood pressure, fasting lipids/glucose, self-reported PA, dietary intake, cigarette smoking). In Aim 4a, we will characterize effects of increasing PA on integrated serologic cytokine/chemokine and lipid inflammatory intermediates to identify potential novel inflammatory pathways linked to cardiometabolic risk phenotypes most responsive to the multi-level, community-based PA intervention. In Aim 4b, we examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health. In Aim 5, we will conduct iterative testing of the mobile health technology used in the protocol with a user-centered design approach. In Aim 6a & 6b, we will assess for changes in cardiac structure and function as well as body composition using MRI before and after the intervention. In Aim 7a and 7b, the intersection of common biological signatures of menopause, sleep disruption, and blood pressure as a marker of cardiometabolic risk in the setting of adverse social determinants of health will be investigated in the study population . We will also determine the feasibility of measuring behavioral and psychosocial mediating factors of the relationship between PA change and cardiometabolic health in this intervention, including chronic psychological/environmental stress and sedentary behavior/sleep. Also, since PA has the potential to improve sleep, vascular function, autonomic regulation, and inflammatory status, incorporating the sleep study and ambulatory blood pressure monitoring (ABPM) further provides more insights on how the behavioral changes from the Step-it-Up intervention translate into clinically meaningful physiological improvements in this population.
In addition, because of the COVID-19 pandemic in 2020, we will measure exposure to COVID-19 and psychosocial stress caused by the pandemic as potential confounders of immunologic outcomes and psychosocial stressors in this study. Finally, we will explore the relationships between PA, social determinants of health, and biological markers in this intervention cohort and compare them to other populations using available cohort data. This project provides fundamental knowledge towards the development of tailored, effective behavioral interventions incorporating mHealth technology to promote health among populations most impacted by health disparities.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Marie Marah, R.N.
- Telefonnummer: (301) 640-1701
- E-Mail: marie.marah@nih.gov
Studieren Sie die Kontaktsicherung
- Name: Tiffany M Powell-Wiley, M.D.
- Telefonnummer: (301) 496-5817
- E-Mail: powelltm2@mail.nih.gov
Studienorte
-
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Maryland
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Bethesda, Maryland, Vereinigte Staaten, 20892
- Rekrutierung
- National Institutes of Health Clinical Center
-
Kontakt:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Telefonnummer: TTY8664111010 800-411-1222
- E-Mail: prpl@cc.nih.gov
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
- 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.
- Cognitively impaired.
Pilot Study INCLUSION CRITERIA:
- 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.
In addition to the Step it Up Study's exclusion criteria, during the screening visit, which can happen by telephone or telehealth, participants will be asked for certain conditions such as bilateral arm deformity, significant peripheral vascular disease, lymphedema, an arteriovenous (AV) fistula or graft in the monitoring arm, severe skin conditions or wounds at the cuff site, inability to tolerate cuff inflation, severe blood disorder or coagulopathy, and any other condition deemed unsafe at the discretion of the principal investigator.
Additionally, participants will not be eligible for the optional Sleep Sub-study if:
- they are unwilling or unable to be evaluated and followed as clinically indicated (examples might include participants with severe behavioral problems who refuse physical examination).
- they do not have a primary healthcare provider or do not accept recommendations provided by study team for provider resources / referral networks.
- they have a chronic or acute medical condition severe enough to interfere with overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, ventilator dependency, or history of stroke or major neurologic insult.
- they work night shift.
- they have started any new medications that modify sleep within the last two weeks.
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: 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. |
Image reconstruction software radiofrequency coils pulse sequences Image Reconstruction and Analysis Software Bluetooth-enabled glucometer 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. 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. 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. |
|
Sonstiges: 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. |
Image reconstruction software radiofrequency coils pulse sequences Image Reconstruction and Analysis Software Bluetooth-enabled glucometer 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. 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. 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in physical activity, measured as average steps per day
Zeitfenster: Baseline/run-in through approximately 3 months after randomization
|
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cardiac structure, function, and perfusion
Zeitfenster: Optional CMR during the run-in/baseline period and again within the month-6 visit window
|
Assess changes in biventricular and left-ventricular structure and function, myocardial characteristics, and vasodilator stress perfusion using cardiovascular magnetic resonance in an optional subset. |
Optional CMR during the run-in/baseline period and again within the month-6 visit window
|
|
Mobile-health technology feasibility and acceptability
Zeitfenster: Pilot period of approximately 23 days; intervention period up to approximately 6.5 months
|
Evaluate usability, acceptability, functionality, engagement, message delivery, app use, wearable-device adherence, and completion of ecological momentary assessments and educational modules. |
Pilot period of approximately 23 days; intervention period up to approximately 6.5 months
|
|
Psychosocial and behavioral mediators
Zeitfenster: Baseline, approximately 3 months, and approximately 6 months
|
Assess chronic psychological and environmental stress, social support and isolation, perceived discrimination, neighborhood environment, sedentary behavior, sleep quality and duration, and other factors that may mediate or modify the relationship between physical activity and cardiovascular health. |
Baseline, approximately 3 months, and approximately 6 months
|
|
Inflammatory and immunometabolic biomarkers
Zeitfenster: Baseline, approximately 3 months, and approximately 6 months
|
Characterize changes associated with increasing physical activity in cytokines, chemokines, lipid inflammatory intermediates, vascular/endothelial markers, immune-cell measures, and related inflammatory pathways. |
Baseline, approximately 3 months, and approximately 6 months
|
|
Cardiometabolic health factors
Zeitfenster: Baseline, approximately 3 months, and approximately 6 months
|
Evaluate changes in BMI, weight, waist and hip circumference, blood pressure, fasting lipids, fasting glucose, hemoglobin A1c, insulin-resistance markers, dietary intake/DASH adherence, self-reported moderate-to-vigorous physical activity, and cigarette smoking. |
Baseline, approximately 3 months, and approximately 6 months
|
|
Feasibility of remote cardiometabolic monitoring
Zeitfenster: During the intervention, up to approximately 6 months
|
Assess participant use and data capture from wireless devices for blood pressure, weight/body fat percentage, and blood glucose. Feasibility measures include device use, data upload, and completeness of measurements. |
During the intervention, up to approximately 6 months
|
|
Physical activity response across adaptive interventions
Zeitfenster: Baseline/run-in, approximately 3 months, and approximately 6 months
|
Compare change in objectively measured steps per day across the four embedded adaptive intervention strategies, including continued coaching, tailored-to-place coaching, increased messaging, and virtual or face-to-face coaching. |
Baseline/run-in, approximately 3 months, and approximately 6 months
|
|
Body composition
Zeitfenster: Optional MRI at baseline or within the first month and again before or after the month-6 visit
|
Assess changes in visceral and subcutaneous adipose tissue, liver fat, intramuscular fat, muscle volume, and related body-composition measures using noncontrast MRI. |
Optional MRI at baseline or within the first month and again before or after the month-6 visit
|
|
Sleep and ambulatory blood pressure
Zeitfenster: Sleep sub-study: 48-hour ABPM and overnight polysomnography after enrollment or study completion
|
Examine relationships between sleep quality, sleep architecture particularly slow-wave sleep-and ambulatory systolic and diastolic blood pressure among postmenopausal participants. |
Sleep sub-study: 48-hour ABPM and overnight polysomnography after enrollment or study completion
|
|
Immunometabolic mediation of sleep blood-pressure relationships
Zeitfenster: Sleep sub-study visits, generally around the ABPM and polysomnography assessments
|
Determine whether cortisol, immune-cell function, and other immunometabolic markers mediate the association between sleep parameters and ambulatory blood pressure. |
Sleep sub-study visits, generally around the ABPM and polysomnography assessments
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Tiffany M Powell-Wiley, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
Nützliche Links
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Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 170162
- 17-H-0162
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