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

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ClinicalTrials.gov Identifier: NCT03288207
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
George Washington University
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date September 19, 2017
First Posted Date September 20, 2017
Last Update Posted Date May 14, 2020
Actual Study Start Date June 21, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 1, 2018)
To determine if there is a difference in PA change (as measured by steps/day) by beginning an adaptive intervention w remote coaching tailored to neighborhood resources (referred to as "tailored-to-place coaching) vs beginning w standard remo... [ Time Frame: 6 months ]
Reduction of obesity and improvement of cardiovascular health
Original Primary Outcome Measures
 (submitted: September 19, 2017)
Steps per day as measured by the PA (physical activity) device [ Time Frame: 3 months and 6 months ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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
  • 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.

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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition Obesity
Intervention Not Provided
Study Groups/Cohorts 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 19, 2017)
180
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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:

  1. Medical condition, including recent unintentional weight loss, that might prohibit safe participation in the intervention
  2. Diagnosis of diabetes mellitus by self-report
  3. Fasting blood glucose greater than or equal to 126 mg/dL in absence of prior diagnosis of diabetes mellitus
  4. 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)
  5. Hyper- or hypothyroid by routine lab screening
  6. Physically unable to perform the physical activity for any reason
  7. Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise.
  8. Currently participating in a structured exercise or weight-loss program (e.g., Weight Watchers, NutriSystem, or fitness training)
  9. Have undergone weight loss (bariatric) surgery

Pilot Study INCLUSION CRITERIA:

Must be an African-American female

Must be within the age of 25-75 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

Must not have a history of bariatric surgery

Must not be enrolled in structured exercise or weight-loss program (e.g. Weight Watchers, NutriSystem, or regularly working with a fitness trainer) during the time of enrollment.

Sex/Gender
Sexes Eligible for Study: Female
Ages 25 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Valerie Morales-Mitchelll (301) 827-4981 valerie.mitchell@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03288207
Other Study ID Numbers 170162
17-H-0162
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators George Washington University
Investigators
Principal Investigator: Tiffany M Powell-Wiley, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 11, 2020