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

• ClinicalTrials.gov Identifier: NCT03288207
• Recruitment Status: Recruiting
• First Posted: September 20, 2017
• Last Update Posted: March 22, 2023
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Collaborator: George Washington University
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Device: Bluetooth-enabled glucometer; Device: Bluetooth-enabled scale; Device: Global Positioning System (GPS) Device; Device: Step it Up mobile app	Not Applicable

Detailed Description:

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 disparities.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 265 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: June 21, 2018
• Estimated Primary Completion Date: October 9, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Group 2 Label: PA monitor with standard remote coaching (SRC); African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.	Device: Bluetooth-enabled glucometer; Bluetooth-enabled glucometer; Device: Bluetooth-enabled scale; Bluetooth-enabled scale; Device: Global Positioning System (GPS) Device; Global Positioning System (GPS) Device; Device: Step it Up mobile app; Step it Up mobile app
Group 1 Label: PA monitor with remote coaching tailored to place; African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.	Device: Bluetooth-enabled glucometer; Bluetooth-enabled glucometer; Device: Bluetooth-enabled scale; Bluetooth-enabled scale; Device: Global Positioning System (GPS) Device; Global Positioning System (GPS) Device; Device: Step it Up mobile app; Step it Up mobile app

Outcome Measures

Primary Outcome Measures :

1. The difference in physical activity (PA) change between an adaptive intervention with remote coaching tailored to neighborhood resources (referred to as tailored-to-place coaching) versus beginning w/ standard remote coaching [ Time Frame: baseline, and up to 6 months ]
   The difference in physical activity (PA) change (as measured by steps/day) by beginning an adaptive intervention with remote coaching tailored to neighborhood resources (referred to as tailored-to-place coaching) versus beginning with standard remote coaching.

Secondary Outcome Measures :

1. Determine which embedded adaptive interventions produce the largest PA increase [ Time Frame: Up to 6 months ]
   Determine which of four embedded adaptive interventions produce the largest PA increase over six months
2. Examine the feasibility of incorporating methods for remote capture of CV health measures [ Time Frame: Up to 6 months ]
   Examine the feasibility of incorporating methods for remote capture of CV health measures (weight, blood pressure, blood glucose) in a target community-based population
3. Examine the effect of an adaptive community-based intervention targeting Physical Activity on Cardiovascular health measures [ Time Frame: Up to 6 months ]
   Examine the effect of an adaptive community-based intervention targeting Physical Activity on Cardiovascular health measures (BMI, blood pressure, fasting lipids, fasting plasma glucose, dietary intake, [self-reported minutes of moderate/vigorous PA, cigarette smoking)
4. Identify potential novel inflammatory pathways linked to cardiometabolic risk phenotypes [ Time Frame: Up to 6 months ]
   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
5. Examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health [ Time Frame: Up to 6 months ]
   Examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health, such as chronic stress and sedentary behavior/sleep
6. Measure exposure to COVID-19 and psychosocial stress caused by the pandemic [ Time Frame: Up to 6 months ]
   Measure exposure to COVID-19 and psychosocial stress caused by the pandemic as potential confounders of immunologic outcomes and psychosocial stressors

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

• INCLUSION CRITERIA:

Individuals eligible for this protocol are overweight or obese (BMI >= 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 obstructive coronary artery 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. Self-reported pregnancy status will be accepted.

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

Contacts and Locations

Contacts

Contact: Valerie Morales-Mitchelll; (301) 827-4981; valerie.mitchell@nih.gov

Contact: Tiffany M Powell-Wiley, M.D.; (301) 594-3735; powelltm2@mail.nih.gov

Locations

United States, Maryland

National Institutes of Health Clinical Center; Recruiting

Bethesda, Maryland, United States, 20892

Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

George Washington University

Investigators

• Principal Investigator: Tiffany M Powell-Wiley, M.D.; National Heart, Lung, and Blood Institute (NHLBI)

More Information

Additional Information:

NIH Clinical Center Detailed Web Page 

Publications:

Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez 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. No abstract available.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tamura K, Vijayakumar NP, Troendle JF, Curlin K, Neally SJ, Mitchell VM, Collins BS, Baumer Y, Gutierrez-Huerta CA, Islam R, Turner BS, Andrews MR, Ceasar JN, Claudel SE, Tippey KG, Giuliano S, McCoy R, Zahurak J, Lambert S, Moore PJ, Douglas-Brown M, Wallen GR, Dodge T, Powell-Wiley TM. Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity. BMJ Open. 2020 Dec 21;10(12):e040702. doi: 10.1136/bmjopen-2020-040702.

• Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
• ClinicalTrials.gov Identifier: NCT03288207
• Other Study ID Numbers: 170162; 17-H-0162
• First Posted: September 20, 2017
• Last Update Posted: March 22, 2023
• Last Verified: March 17, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):

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

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight