NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
| NCT ID | NCT03288207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 325 participants |
| Start Date | 2018-06-21 |
| Primary Completion | 2026-08-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 325 participants in total. It began in 2018-06-21 with a primary completion date of 2026-08-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
* 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.
Contact & Investigator
Tiffany M Powell-Wiley, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT03288207 clinical trial?
This trial is open to female participants only, aged 21 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03288207 currently recruiting?
Yes, NCT03288207 is actively recruiting participants. Contact the research team at marie.marah@nih.gov for enrollment information.
Where is the NCT03288207 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT03288207 clinical trial?
NCT03288207 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Tiffany M Powell-Wiley, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 325 participants.
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