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

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Sep 19, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring how mobile health technology, like smartphone apps and activity monitors, can help increase physical activity and reduce obesity among African American women living in certain neighborhoods around Washington, DC. The goal is to see if these tools can help participants exercise more, which may lower their risk of heart disease.

To be eligible for the study, participants must be African American women between the ages of 21 and 75 who are overweight or obese, live in specific areas of Washington, DC, or nearby Prince George’s County, and have a smartphone that can use the study app. Once enrolled, participants will answer some questions about their health, wear a device that tracks their activity and sleep, and receive encouragement to exercise through the app. They may also receive additional support, like coaching or devices to monitor their weight and blood pressure, and will have follow-up visits over six months to see how they are doing.

Gender

FEMALE

Eligibility criteria

• * INCLUSION CRITERIA:
• • Individuals eligible for this protocol are overweight or obese (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 be overweight or obese (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
• • 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.