This study is currently recruiting participants.
Number
17-H-0162
Sponsoring Institute
National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Female Min Age: 21 Years Max Age: 75 Years
Referral Letter Required
No
Population Exclusion(s)
Children;Male;Adults who are or may become unable to consent;Pregnant Women;Non-English Speaking;White;Native Hawaiian/Pacific Islander;Hispanic or Latino;Asian;American Indian or Alaskan Native
Keywords
Community-Based Participatory Research; Obesity; Cardiovascular Disease Risk; Social Determinants of Health
Recruitment Keyword(s)
None
Condition(s)
Obesity
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Device: Bluetooth-enabled glucometer Device: Bluetooth-enabled scale Device: Global Positioning System (GPS) Device Device: Step it Up mobile app
Supporting Site
National Heart, Lung, and Blood InstituteGeorge Washington University
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.
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INCLUSION CRITERIA: Individuals eligible for this protocol are overweight or obese (BMI >= 25 kg/m2) 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 recent unintentional weight loss, that might prohibit safe participation in the intervention -Heart disease as indicated by history of myocardial infarction, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement, congestive heart failure, significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) -Physically unable to perform the physical activity for any reason -Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. Self-reported pregnancy status will be accepted. Pilot Study INCLUSION CRITERIA: - Must be an African-American female - Must be within the age of 21-75 years old - Must be overweight or obese (Body Mass Index (BMI) greater than or equal to 25 kg/m <=) - 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
Individuals eligible for this protocol are overweight or obese (BMI >= 25 kg/m2) 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 recent unintentional weight loss, that might prohibit safe participation in the intervention
-Heart disease as indicated by history of myocardial infarction, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement, congestive heart failure, significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease)
-Physically unable to perform the physical activity for any reason
-Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. Self-reported pregnancy status will be accepted.
Pilot Study INCLUSION CRITERIA:
- Must be an African-American female
- Must be within the age of 21-75 years old
- Must be overweight or obese (Body Mass Index (BMI) greater than or equal to 25 kg/m <=)
- 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
Principal Investigator
Referral Contact
For more information: