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

  • STATUS
    Recruiting
Updated on 23 November 2020
insulin
fasting
insulin resistance
heart disease
hemoglobin a1c

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 25-75 who:

  • Are overweight or obese
  • Live in certain areas near Washington, DC
  • Are pre-diabetic
  • 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.

 

Please visit our Patient Recruitment Page for more information.

 

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.

 

Please visit our Patient Recruitment Page for more information.

Details
Condition Obesity, Cardiovascular Health, Cardiovascular Disease, CVD
Clinical Study IdentifierTX218179
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals eligible for this protocol are overweight or obese (BMI greater than or equal to 25 kg/m^2)
African American women aged 25-75 years with evidence of insulin resistance based on fasting plasma glucose (FPG=100-125 mg/dL) or hemoglobin A1c (HgA1c=5.7% to 6.4%) 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
Self-directed exercise (walks around the block, climbing stairs) is acceptable for inclusion, with subjects encouraged to continue such activity throughout the program
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
Diagnosis of diabetes mellitus by self-report
Fasting blood glucose greater than or equal to 126 mg/dL in absence of prior diagnosis of diabetes mellitus
Heart disease as indicated by history of myocardial infarction, documented disease on coronary angiography, coronary artery stent placement, congestive heart failure, significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease)
Hyper- or hypothyroid by routine lab screening
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
Currently participating in a structured exercise or weight-loss program (e.g., Weight Watchers, NutriSystem, or fitness training)
Have undergone weight loss (bariatric) surgery
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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