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

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-75
SponsorNational Heart, Lung, and Blood Institute (NHLBI)

About this trial

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.

...

Eligibility criteria

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

325 Participants
are divided into 2 treatment groups

Sponsors and collaborators