Using mobile health technology to help African American women reduce obesity and improve heart health
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments: A Multi-Level, Community-Based Physical Activity Intervention
This study is testing if using mobile health technology can help overweight African American women in Washington, DC, become more active and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 325 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | Female |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03288207 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of mobile health technology in increasing physical activity among overweight or obese African American women living in resource-limited neighborhoods near Washington, DC. Participants will engage in a community-based intervention that includes remote coaching and the use of wearable devices and mobile applications to track their physical activity. The study will assess various health metrics, including cardiometabolic measures, to determine the impact of increased physical activity on overall health. The research will also explore which adaptive interventions yield the best results over a six-month period.
Who should consider this trial
Good fit: Ideal candidates for this study are overweight or obese African American women aged 21-75 who live in specific neighborhoods near Washington, DC and have access to a compatible smartphone.
Not a fit: Patients with significant medical conditions that limit their ability to safely participate in physical activity, such as recent heart disease or physical limitations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular health and reduced obesity rates among African American women.
How similar studies have performed: Other studies have shown promise in using mobile health technology for increasing physical activity, but this specific approach targeting African American women in resource-limited environments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Tiffany M Powell-Wiley, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Marie Marah, R.N.
- Email: marie.marah@nih.gov
- Phone: (301) 640-1701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.