临床试验/NCT03288207

NCT03288207招募中不适用

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

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点分布在 1 个国家目标入组 325 人开始时间: 2018年6月21日最近更新: 2026年9月16日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方: National Heart, Lung, and Blood Institute (NHLBI)
入组人数: 325
试验地点: 1
主要终点: 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

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Background

Obesity and physical inactivity contribute substantially to cardiovascular disease risk, diabetes, hypertension, and dyslipidemia. African American women experience disproportionately high rates of obesity and have among the lowest levels of physical activity and greatest sedentary time in the United States. Resource-limited neighborhoods may further constrain physical activity through limited access to safe parks, recreation facilities, walking routes, and other health-promoting resources.

This protocol builds on prior community-based work in Washington, D.C., which demonstrated the feasibility of wearable activity monitoring among predominantly African American women in faith-based, lower-resource communities. It uses community-based participatory research principles and mobile health technology to deliver physical-activity coaching tailored either to individual factors or to available neighborhood resources.

Objectives

Primary objective

To determine whether initiating an adaptive physical-activity intervention with remote, mobile-app coaching tailored to neighborhood physical-activity resources "tailored-to-place" coaching-produces a greater increase in steps per day over approximately three months than standard remote coaching.

Secondary objectives

The study will also:

Compare four embedded adaptive intervention strategies over approximately six months.

Assess the feasibility of remotely measuring weight, blood pressure, and blood glucose using connected devices.

Evaluate effects on cardiometabolic measures, including BMI, blood pressure, lipids, glucose, dietary intake, self-reported physical activity, and smoking.

Examine inflammatory, lipid, immunometabolic, psychosocial, behavioral, and social-determinants-of-health pathways related to physical-activity change.

Evaluate changes in cardiac structure and function and body composition using optional cardiovascular and body-composition MRI.

Assess relationships among sleep, ambulatory blood pressure, menopause-related factors, and immunometabolic markers in a postmenopausal sleep sub-study.

Conduct user-centered testing of the mobile application and wearable/mobile health technologies.

Explore COVID-19 exposure and pandemic-related psychosocial stress as potential confounders of immunologic and psychosocial outcomes.

Eligibility: Inclusion Criteria

Participants must:

Be African American women aged 21-75 years.

Have overweight or obesity, defined as BMI >=25 kg/m^2

Live in Washington, D.C., Wards 5, 7, or 8, or in neighboring areas of Prince George's County, Maryland.

Have access to a smartphone compatible with the study application.

Be able to provide informed consent independently.

Speak and read English at approximately an eighth-grade level.

Participants enter a two-week run-in period. Those averaging 7,500 steps per day or fewer and who complete the run-in are eligible for randomization into the intervention.

Main study exclusion criteria

Potential participants are excluded for conditions that could make increased physical activity unsafe or interfere with study assessments, including:

Medical conditions or physical limitations that prohibit safe participation in physical activity.

Recent myocardial infarction, documented obstructive coronary artery disease, recent coronary stenting, or significant decompensated structural heart disease.

Pregnancy; pregnancy status is assessed as applicable during study visits.

Other conditions determined by the investigator to make participation unsafe.

Sleep sub-study eligibility

The optional sleep sub-study is limited to postmenopausal women who are enrolled in or have completed the main study. Additional exclusions include night-shift work, conditions that interfere with overnight polysomnography, recent initiation of sleep-modifying medications, inability to tolerate ambulatory blood-pressure monitoring, and certain arm, vascular, skin, bleeding, or neurologic conditions.

MRI participation is optional and requires separate screening for MRI-incompatible implanted devices or metal and, when applicable, eligibility for gadolinium contrast.

Study design

A six-month adaptive randomized trial will enroll overweight or obese African American women. After a two-week run-in, participants averaging <=7,500 steps/day will receive either standard mobile-app coaching or coaching tailored to neighborhood physical-activity resources. At three months, nonresponders will be reassigned to intensified coaching. Steps will be measured with a wearable device, with assessments at baseline, three months, and six months. Optional monitoring and MRI/sleep sub-studies will assess cardiometabolic outcomes....

详细描述

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 4a, 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. In Aim 4b, we examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health. In Aim 5, we will conduct iterative testing of the mobile health technology used in the protocol with a user-centered design approach. In Aim 6a and 6b, we will assess for changes in cardiac structure and function as well as body composition using MRI before and after the intervention. In Aim 7a and 7b, the intersection of common biological signatures of menopause, sleep disruption, and blood pressure as a marker of cardiometabolic risk in the setting of adverse social determinants of health will be investigated in the study population. 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. Also, since PA has the potential to improve sleep, vascular function, autonomic regulation, and inflammatory status, incorporating the sleep study and ambulatory blood pressure monitoring (ABPM) further provides more insights on how the behavioral changes from the Step-it-Up intervention translate into clinically meaningful physiological improvements in this population.

In addition, because of the COVID-19 pandemic in 2020, we will measure exposure to COVID-19 and psychosocial stress caused by the pandemic as potential confounders of immunologic outcomes and psychosocial stressors in this study. Finally, we will explore the relationships between PA, social determinants of health, and biological markers in this intervention cohort and compare them to other populations using available cohort data. 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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Basic Science
盲法: Single (Participant)

入排标准

年龄范围: 21 Years 至 75 Years（Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•INCLUSION CRITERIA:
•Individuals eligible for this protocol have overweight or obesity (BMI >= 25 kg/m^2) 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.

排除标准

•Medical condition, including heart failure, recent unintentional weight loss or physical limitation, that might prohibit safe participation in physical activity for any reason
•Heart disease as indicated by history of myocardial infarction in past 1 year, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement within the last year significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy with EF <35%, severe valvular heart disease) with evidence of decompensation.
•Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. All participants of childbearing potential will need to self-report a negative pregnancy at the screening visit, baseline visit, and at the three-month and six-month visits, unless the participant self-reports being postmenopausal, having had a tubal ligation, or having undergone a complete hysterectomy.
•Pilot Study INCLUSION CRITERIA:
•Must be an African-American female
•Must be within the age of 21-75 years old
•Must have overweight or obesity (Body Mass Index (BMI) >= 25 kg/m^2)
•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
•Eligibility for Post-Menopausal Status for Sleep Sub-study:
•Eligibility is limited to post-menopausal women who have either completed or are currently enrolled in the main study. Confirmation of post-menopausal status will be determined by review of medical history prior to final eligibility assessment for the study. In patients with prior hysterectomy and retained ovaries, menopause cannot be diagnosed using menstrual criteria. Diagnosis will be made clinically based on age consistent with natural menopause ( >=45) and the presence of menopausal symptoms, such as vasomotor or genitourinary symptoms.
•In addition to the Step it Up Study's exclusion criteria, during the screening visit, which can happen by telephone or telehealth, participants will be asked for certain conditions such as bilateral arm deformity, significant peripheral vascular disease, lymphedema, an arteriovenous (AV) fistula or graft in the monitoring arm, severe skin conditions or wounds at the cuff site, inability to tolerate cuff inflation, severe blood disorder or coagulopathy, and any other condition deemed unsafe at the discretion of the principal investigator.
•Additionally, participants will not be eligible for the optional Sleep Sub-study if:
•they are unwilling or unable to be evaluated and followed as clinically indicated (examples might include participants with severe behavioral problems who refuse physical examination).
•they do not have a primary healthcare provider or do not accept recommendations provided by study team for provider resources / referral networks.
•they have a chronic or acute medical condition severe enough to interfere with overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, ventilator dependency, or history of stroke or major neurologic insult.
•they work night shift.
•they have started any new medications that modify sleep within the last two weeks.
•Optional MRI Tests
•Subjects will be screened for implanted metal objects or devices that may be incompatible with MRI (i.e. cerebral aneurysm clip, cochlear implant, pacemaker, etc.) These subjects will be eligible to proceed with study enrollment but will not undergo the optional MRI study.