Recruiting

Mobile Health Technology

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT03288207

Conditions

Obesity

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

AMRA(r) Researcher Image reconstruction software

MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.)

MRI: Research pulse sequences (Device Manufacturer: NIH)

MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH)

Bluetooth-enabled glucometer

Study Details

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....

Conditions

Obesity

Study ID

NCT03288207

Start date

Jun 21, 2018

Status verified date

Sep 4, 2026

Completion date

Aug 4, 2027

Anticipated

Primary completion date

Aug 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Accepted

  • 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.

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.

Study Design

Enrollment

325 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: 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.

other: 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.

Interventions

AMRA(r) Researcher Image reconstruction software

Image reconstruction software

MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.)

radiofrequency coils

MRI: Research pulse sequences (Device Manufacturer: NIH)

pulse sequences

MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH)

Image Reconstruction and Analysis Software

Bluetooth-enabled glucometer

Bluetooth-enabled glucometer

Remote tailored-to-place coaching (TPC)

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.

Standard remote coaching (SRC)

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.

Run-in physical-activity monitoring

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.

Ambulatory blood-pressure monitor

Measures systolic and diastolic blood pressure and pulse over approximately 48 hours during usual daily activities.

Polysomnography equipment

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.

Primary outcome measure

  • Change in physical activity, measured as average steps per day [ Time Frame: Baseline/run-in through approximately 3 months after randomization ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Sep 16, 2026

Last verified

Sep 4, 2026

Keywords

  • Community-Based Participatory Research
  • Obesity
  • Cardiovascular Disease Risk
  • Social Determinants of Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-09-16.