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

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT03288207
Collaborator
George Washington University (Other)
180
Enrollment
1
Location
42.3
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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

  • 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.

Condition or DiseaseIntervention/TreatmentPhase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    180 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jun 21, 2018
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    ArmIntervention/Treatment
    Mobile Health

    African-American female; age of 25-75 years oldMust be overweight or obese (Body Mass Index (BMI) greater than or equal to 25 kg/m^2)Must live in Washington DC Wards (5, 7, or 8)

    Outcome Measures

    Primary Outcome Measures

    1. to determine if there is a difference in 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 standar... [6 months]

      Reduction of obesity and improvement of cardiovascular health

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    • INCLUSION CRITERIA:

    Individuals eligible for this protocol are overweight or obese (BMI greater than or equal to 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 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.

    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1National Institutes of Health Clinical CenterBethesdaMarylandUnited States20892

    Sponsors and Collaborators

    • National Heart, Lung, and Blood Institute (NHLBI)
    • George Washington University

    Investigators

    • Principal Investigator: Tiffany M Powell-Wiley, M.D., National Heart, Lung, and Blood Institute (NHLBI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    National Heart, Lung, and Blood Institute (NHLBI)
    ClinicalTrials.gov Identifier:
    NCT03288207
    Other Study ID Numbers:
    • 170162
    • 17-H-0162
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Sep 8, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021