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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments: A Multi-Level, Community-Based Physical Activity Intervention

Conditions
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Obesity

Intervention / Treatment
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* Device: Bluetooth-enabled glucometer
* Device: Bluetooth-enabled scale
* Device: Global Positioning System (GPS) Device
* Device: Step it Up mobile app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-Based Participatory Research, Obesity, Cardiovascular Disease Risk, Social Determinants of Health