Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT03288207
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AMRA(r) Researcher Image reconstruction software — DEVICE
    Image reconstruction software
  • MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.) — DEVICE
    radiofrequency coils
  • MRI: Research pulse sequences (Device Manufacturer: NIH) — DEVICE
    pulse sequences
  • MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH) — DEVICE
    Image Reconstruction and Analysis Software
  • Bluetooth-enabled glucometer — DEVICE
    Bluetooth-enabled glucometer
  • Remote tailored-to-place coaching (TPC) — DEVICE
    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) — OTHER
    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 — DEVICE
    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 — DEVICE
    Measures systolic and diastolic blood pressure and pulse over approximately 48 hours during usual daily activities.
  • Polysomnography equipment — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Sep 20, 2017
Start date
Jun 21, 2018
Status verified
Sep 2026
Primary completion
Aug 4, 2027
Completion
Aug 4, 2027

Study Design

Enrollment
325 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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