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.
To find out if mobile health technology can increase physical activity.
African American women ages 18-75 who:
- Are overweight or obese
- Live in certain areas near Washington, DC
- Are pre-diabetic
- Have a smartphone that can use the study app
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.
Targeted, effective behavioral interventions are critically needed to ameliorate the
disproportionate prevalence of poor cardiometabolic health for African-American women. We
propose a sequential, multiple-assignment, randomized trial targeting physical activity (PA)
among at-risk African-American women in resource-limited, Washington, D.C. communities using
mobile health (mHealth) technology. We hypothesize that by beginning a community-based,
adaptive PA intervention with remote coaching tailored to neighborhood environment PA
resources, we will see greater increases in PA levels as compared to standard remote
coaching. In Aim 1, we will determine if beginning an adaptive intervention with remote
coaching tailored to neighborhood environment resources and delivered using mHealth
technology (wearables and mobile applications) will lead to a greater PA increase (as
measured by steps per day) as compared to standard remote coaching. In Aim 2, we will examine
which of four embedded adaptive interventions produce the largest PA increase over the
six-month study period. In Aim 3, we will evaluate the feasibility of remote capture of
cardiometabolic measures, including blood pressure, weight, and glucose, using mHealth
technology. We will also examine intervention effects on cardiometabolic health (adiposity,
blood pressure, fasting lipids/glucose, self-reported PA, dietary intake, cigarette smoking).
In Aim 4, we will characterize effects of increasing PA on integrated serologic
cytokine/chemokine and lipid inflammatory intermediates to identify potential novel
inflammatory pathways linked to cardiometabolic risk phenotypes most responsive to the
multi-level, community-based PA intervention. We will also determine the feasibility of
measuring behavioral and psychosocial mediating factors of the relationship between PA change
and cardiometabolic health in this intervention, including chronic
psychological/environmental stress and sedentary behavior/sleep. This project provides
fundamental knowledge towards the development of tailored, effective behavioral interventions
incorporating mHealth technology to promote health among populations most impacted by health
|Condition or disease
|First Submitted Date||September 19, 2017|
|Last Update Posted Date||February 23, 2018|
|Anticipated Start Date||March 01, 2018|
|Anticipated Completion Date||December 31, 2020|
|Anticipated Primary Completion Date||December 31, 2020|
|Results First Submitted Date||N/A|
|Received Results Disposit Date||N/A|
Current Primary Outcome Measures
Steps per day as measured by the PA (physical activity) device
[Time Frame: 3 months and 6 months]
Original Primary Outcome Measures
Current Secondary Outcome Measures
Original Secondary Outcome Measures
|Brief Title||Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments|
|Official Title||Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments: A Multi-Level, Community-Based Physical Activity Intervention|
|Target Follow-Up Duration|| N/A|
|Sampling Method||Non-Probability Sample|
|Study Population||We propose a sequential, multiple-assignment, randomized trial targeting physical activity
(PA) among at-risk African-American women in resource-limited, Washington, D.C. communities
using mobile health (mHealth) technology.|
targeting physical activity (PA) among at-risk African-American women in resource-limited, Washington, D.C. communities
|Recruitment Status:||Not yet recruiting|
|Completion Date||December 31, 2020|
- INCLUSION CRITERIA:|
Individuals eligible for this protocol are overweight or obese (BMI greater than or equal
to 25 kg/m^2) African American women aged 18-75 years with evidence of insulin resistance
based on fasting plasma glucose (FPG=100-125 mg/dL) or hemoglobin A1c (HgA1c=5.7% to 6.4%)
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. Self-directed exercise (walks
around the block, climbing stairs) is acceptable for inclusion, with subjects encouraged to
continue such activity throughout the program. Eligible participants must be able to
provide informed consent independently and also speak and read English at the 8th grade
1. Medical condition, including recent unintentional weight loss, that might prohibit
safe participation in the intervention
2. Diagnosis of diabetes mellitus by self-report
3. Fasting blood glucose greater than or equal to 126 mg/dL in absence of prior diagnosis
of diabetes mellitus
4. Heart disease as indicated by history of myocardial infarction, documented disease on
coronary angiography, coronary artery stent placement, congestive heart failure,
significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy,
valvular heart disease)
5. Hyper- or hypothyroid by routine lab screening
6. Physically unable to perform the physical activity for any reason
7. Pregnant women due to large hormonal changes during pregnancy that affect study
variables and potential pregnancy-related restrictions on exercise.
8. Currently participating in a structured exercise or weight-loss program (e.g., Weight
Watchers, NutriSystem, or fitness training)
9. Have undergone weight loss (bariatric) surgery
|Age||18 Years to 75 Years|
|Accepts Healthy Volunteers||No|
|Listed Location Countries
|Other Study ID Numbers
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
|IPD Sharing Statement
|Responsible Party||, |
Tiffany M Powell-Wiley, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, DesprÃ©s JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, JimÃ©nez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366.