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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bluetooth-enabled glucometer
Bluetooth-enabled scale
Global Positioning System (GPS) Device
Step it Up mobile app
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Community-Based Participatory Research, Obesity, Cardiovascular Disease Risk, Social Determinants of Health

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers
  • 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 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

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 2 Label: PA monitor with standard remote coaching (SRC)

Group 1 Label: PA monitor with remote coaching tailored to place

Arm Description

African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.

African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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)
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
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
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

Full Information

First Posted
September 19, 2017
Last Updated
October 20, 2023
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT03288207
Brief Title
Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 29, 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
February 9, 2025 (Anticipated)
Study Completion Date
March 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborators
George Washington University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Community-Based Participatory Research, Obesity, Cardiovascular Disease Risk, Social Determinants of Health

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
265 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 2 Label: PA monitor with standard remote coaching (SRC)
Arm Type
Other
Arm Description
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Arm Title
Group 1 Label: PA monitor with remote coaching tailored to place
Arm Type
Other
Arm Description
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
Intervention Type
Device
Intervention Name(s)
Bluetooth-enabled glucometer
Intervention Description
Bluetooth-enabled glucometer
Intervention Type
Device
Intervention Name(s)
Bluetooth-enabled scale
Intervention Description
Bluetooth-enabled scale
Intervention Type
Device
Intervention Name(s)
Global Positioning System (GPS) Device
Intervention Description
Global Positioning System (GPS) Device
Intervention Type
Device
Intervention Name(s)
Step it Up mobile app
Intervention Description
Step it Up mobile app
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
baseline, and up to 6 months
Secondary Outcome Measure Information:
Title
Determine which embedded adaptive interventions produce the largest PA increase
Description
Determine which of four embedded adaptive interventions produce the largest PA increase over six months
Time Frame
Up to 6 months
Title
Examine the feasibility of incorporating methods for remote capture of CV health measures
Description
Examine the feasibility of incorporating methods for remote capture of CV health measures (weight, blood pressure, blood glucose) in a target community-based population
Time Frame
Up to 6 months
Title
Examine the effect of an adaptive community-based intervention targeting Physical Activity on Cardiovascular health measures
Description
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)
Time Frame
Up to 6 months
Title
Identify potential novel inflammatory pathways linked to cardiometabolic risk phenotypes
Description
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
Time Frame
Up to 6 months
Title
Examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health
Description
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
Time Frame
Up to 6 months
Title
Measure exposure to COVID-19 and psychosocial stress caused by the pandemic
Description
Measure exposure to COVID-19 and psychosocial stress caused by the pandemic as potential confounders of immunologic outcomes and psychosocial stressors
Time Frame
Up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Morales-Mitchelll
Phone
(301) 827-4981
Email
valerie.mitchell@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Tiffany M Powell-Wiley, M.D.
Phone
(301) 594-3735
Email
powelltm2@mail.nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany M Powell-Wiley, M.D.
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY8664111010
Email
prpl@cc.nih.gov

12. IPD Sharing Statement

Citations:
PubMed Identifier
26811276
Citation
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
Results Reference
background
PubMed Identifier
21899451
Citation
Boggs DA, Rosenberg L, Cozier YC, Wise LA, Coogan PF, Ruiz-Narvaez EA, Palmer JR. General and abdominal obesity and risk of death among black women. N Engl J Med. 2011 Sep 8;365(10):901-8. doi: 10.1056/NEJMoa1104119.
Results Reference
background
PubMed Identifier
19833999
Citation
Lightwood J, Bibbins-Domingo K, Coxson P, Wang YC, Williams L, Goldman L. Forecasting the future economic burden of current adolescent overweight: an estimate of the coronary heart disease policy model. Am J Public Health. 2009 Dec;99(12):2230-7. doi: 10.2105/AJPH.2008.152595. Epub 2009 Oct 15.
Results Reference
background
PubMed Identifier
33371027
Citation
Tamura K, Vijayakumar NP, Troendle JF, Curlin K, Neally SJ, Mitchell VM, Collins BS, Baumer Y, Gutierrez-Huerta CA, Islam R, Turner BS, Andrews MR, Ceasar JN, Claudel SE, Tippey KG, Giuliano S, McCoy R, Zahurak J, Lambert S, Moore PJ, Douglas-Brown M, Wallen GR, Dodge T, Powell-Wiley TM. Multilevel mobile health approach to improve cardiovascular health in resource-limited communities with Step It Up: a randomised controlled trial protocol targeting physical activity. BMJ Open. 2020 Dec 21;10(12):e040702. doi: 10.1136/bmjopen-2020-040702.
Results Reference
derived
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-H-0162.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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