- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03288207
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie Marah, R.N.
- Phone Number: (301) 640-1701
- Email: marie.marah@nih.gov
Study Contact Backup
- Name: Tiffany M Powell-Wiley, M.D.
- Phone Number: (301) 594-3735
- Email: powelltm2@mail.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY8664111010 800-411-1222
- Email: prpl@cc.nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Group 2 Label: PA monitor with standard remote coaching (SRC)
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
|
Bluetooth-enabled glucometer
Bluetooth-enabled scale
Global Positioning System (GPS) Device
Step it Up mobile app
|
Other: Group 1 Label: PA monitor with remote coaching tailored to place
African American women who are at risk for cardiovascular outcomes in resource-limited communities in the Washington D.C. area.
|
Bluetooth-enabled glucometer
Bluetooth-enabled scale
Global Positioning System (GPS) Device
Step it Up mobile app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: baseline, and up to 6 months
|
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.
|
baseline, and up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine which embedded adaptive interventions produce the largest PA increase
Time Frame: Up to 6 months
|
Determine which of four embedded adaptive interventions produce the largest PA increase over six months
|
Up to 6 months
|
Examine the feasibility of incorporating methods for remote capture of CV health measures
Time Frame: Up to 6 months
|
Examine the feasibility of incorporating methods for remote capture of CV health measures (weight, blood pressure, blood glucose) in a target community-based population
|
Up to 6 months
|
Examine the effect of an adaptive community-based intervention targeting Physical Activity on Cardiovascular health measures
Time Frame: Up to 6 months
|
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)
|
Up to 6 months
|
Identify potential novel inflammatory pathways linked to cardiometabolic risk phenotypes
Time Frame: Up to 6 months
|
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
|
Up to 6 months
|
Examine the feasibility of measuring potential psychosocial and behavioral mediators of the relationship between PA change and CV health
Time Frame: Up to 6 months
|
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
|
Up to 6 months
|
Measure exposure to COVID-19 and psychosocial stress caused by the pandemic
Time Frame: Up to 6 months
|
Measure exposure to COVID-19 and psychosocial stress caused by the pandemic as potential confounders of immunologic outcomes and psychosocial stressors
|
Up to 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tiffany M Powell-Wiley, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170162
- 17-H-0162
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Bluetooth-enabled glucometer
-
Sunnybrook Health Sciences CentreBattlefords Tribal Council Indian Health Services; SaskTelCompletedHypertension | Diabetes MellitusCanada
-
Monash UniversitySegi UniversityCompletedDiabetes Mellitus, Non-Insulin-DependentMalaysia
-
Sheffield Teaching Hospitals NHS Foundation TrustCompleted
-
University of PittsburghNational Cancer Institute (NCI)CompletedSedentary Lifestyle | Colorectal Cancer | Peritoneal CancerUnited States
-
Sir Ganga Ram HospitalCompletedInflammatory Response | Surgical Injury | Music Therapy | Cholecystitis/CholelithiasisIndia
-
Mayo ClinicCompletedSmoking CessationUnited States
-
University of IowaCompletedOverweight | SedentaryUnited States
-
Minnesota HealthSolutionsChildren's Hospital of PhiladelphiaRecruiting
-
Taichung Veterans General HospitalUnknown
-
University Hospital Inselspital, BerneCochlear; Stiftung Besser HörenTerminatedHearing-ImpairmentSwitzerland