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Protocol Details

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 currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

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)

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

Special Instructions

Currently Not Provided

Keywords

Community-Based Participatory Research;
Obesity;
Cardiovascular Disease Risk;
Social Determinants of Health;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Obesity

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood InstituteGeorge Washington University

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 25-75 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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Eligibility

INCLUSION CRITERIA:

Individuals eligible for this protocol are overweight or obese (BMI greater than or equal to 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 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.

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


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Citations:

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despr(SqrRoot)(Copyright)s JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jim(SqrRoot)(Copyright)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.

Boggs DA, Rosenberg L, Cozier YC, Wise LA, Coogan PF, Ruiz-Narvaez EA, Palmer JR. General and abdominal obesity and risk of death among black women. N Engl J Med. 2011 Sep 8;365(10):901-8. doi: 10.1056/NEJMoa1104119.

Lightwood J, Bibbins-Domingo K, Coxson P, Wang YC, Williams L, Goldman L. Forecasting the future economic burden of current adolescent overweight: an estimate of the coronary heart disease policy model. Am J Public Health. 2009 Dec;99(12):2230-7. doi: 10.2105/AJPH.2008.152595. Epub 2009 Oct 15.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Tiffany M. Powell-Wiley, M.D.
National Heart, Lung and Blood Institute (NHLBI)



Tiffany M. Powell-Wiley, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 5-3340
10 CENTER DR
BETHESDA MD 20814
(301) 594-3735
powelltm2@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03288207

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