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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03288207
• Other study ID #: 170162
• Secondary ID: 17-H-0162
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: March 28, 2026

Study information

• Verified date: May 30, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Marie Marah, R.N.
• Phone: (301) 640-1701
• Email: marie.marah[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Est. completion date: March 28, 2026
• Est. primary completion date: February 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 75 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• Bluetooth-enabled glucometer
Bluetooth-enabled glucometer
• Bluetooth-enabled scale
Bluetooth-enabled scale
• Global Positioning System (GPS) Device
Global Positioning System (GPS) Device
• Step it Up mobile app
Step it Up mobile app

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)	George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline, and up to 6 months
Secondary	Determine which embedded adaptive interventions produce the largest PA increase	Determine which of four embedded adaptive interventions produce the largest PA increase over six months	Up to 6 months
Secondary	Examine the feasibility of incorporating methods for remote capture of CV health measures	Examine the feasibility of incorporating methods for remote capture of CV health measures (weight, blood pressure, blood glucose) in a target community-based population	Up to 6 months
Secondary	Examine the effect of an adaptive community-based intervention targeting Physical Activity on Cardiovascular health measures	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)	Up to 6 months
Secondary	Identify potential novel inflammatory pathways linked to cardiometabolic risk phenotypes	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	Up to 6 months
Secondary	Examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health	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	Up to 6 months
Secondary	Measure exposure to COVID-19 and psychosocial stress caused by the pandemic	Measure exposure to COVID-19 and psychosocial stress caused by the pandemic as potential confounders of immunologic outcomes and psychosocial stressors	Up to 6 months

External Links

•   NIH Clinical Center Detailed Web Page