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

  • Step it Up mobile app — DEVICE
    Step it Up mobile app
  • Global Positioning System (GPS) Device — DEVICE
    Global Positioning System (GPS) Device
  • Bluetooth-enabled scale — DEVICE
    Bluetooth-enabled scale
  • Bluetooth-enabled glucometer — DEVICE
    Bluetooth-enabled glucometer
  • MRI: Image Reconstruction and Analysis Software (Device Manufacturer: NIH) — DEVICE
    Image Reconstruction and Analysis Software
  • MRI: Research pulse sequences (Device Manufacturer: NIH) — DEVICE
    pulse sequences
  • MRI: radiofrequency coils (Device Manufacturer: Siemens Medical Solutions USA, Inc.) — DEVICE
    radiofrequency coils
  • AMRA Researcher Image reconstruction software — DEVICE
    Image reconstruction software

Study Details

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.

Key Dates

Start date
Jun 21, 2018
Status verified
Apr 2026
Primary completion
Aug 4, 2026
Completion
Aug 4, 2026

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

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 [ Time Frame: baseline, and up to 6 months ]

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

Find similar trials in Bethesda, MD

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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