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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 75 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months, 6 months
  • Procedures mentioned: MRI scans, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Evaluate changes in cardiac structure and function and body composition using optional cardiovascular and body-composition MRI."
  • "Conduct user-centered testing of the mobile application and wearable/mobile health technologies."
  • "MRI participation is optional and requires separate screening for MRI-incompatible implanted devices or metal and, when applicable, eligibility for gadolinium contrast."
  • "Steps will be measured with a wearable device, with assessments at baseline, three months, and six months."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether phone-app activity coaching based on nearby places to exercise helps women walk more than standard coaching. It is for African American women ages 21–75 with overweight or obesity who live in certain parts of Washington, D.C., or nearby Maryland.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be an African American woman age 21–75.
  • Have a BMI of 25 or higher. BMI is a measure of weight compared with height.
  • Live in Washington, D.C., Wards 5, 7, or 8, or nearby areas of Prince George’s County, Maryland.
  • Have access to a smartphone that works with the study app.
  • Be able to decide on your own to join and give consent. Speak and read English at about an eighth-grade level.
  • Finish a two-week starting period and average 7,500 steps a day or fewer to enter the coaching part of the study.
  • For the pilot study, agree to use the app on your own phone and wear a wrist activity tracker.
  • For the optional sleep study, be past menopause, as confirmed by medical history, and be in or have finished the main study.

Who can't join

  • Have a health problem that could make exercise unsafe, such as heart failure, recent weight loss without trying, or a physical limitation.
  • Have had a heart attack or heart artery stent in the past year, have confirmed blocked heart arteries, or have certain severe heart muscle or valve problems with worsening heart function.
  • Be pregnant.
  • For the optional sleep study: have arm, blood vessel, skin, bleeding, or other problems that make blood pressure cuff use unsafe or hard to tolerate.
  • For the optional sleep study: be unable or unwilling to have needed exams or follow-up care, or lack a primary care provider and not accept help finding one.
  • For the optional sleep study: have a serious condition that could prevent overnight sleep testing, such as uncontrolled seizures, needing a breathing machine, or a past stroke.
  • For the optional sleep study: work night shifts or have started a new medicine that affects sleep within the past two weeks.
  • For optional MRI scans only: have metal or an implanted device that is not safe for MRI. You may still join the main study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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. EXCLUSION CRITERIA: * 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.

Study sites (1)

MD