Phone apps aim to get women moving in underserved neighborhoods
NCT ID NCT03288207
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 25 times
Summary
This study tests whether mobile health technology, like smartphone apps and activity trackers, can help overweight or obese African American women increase their physical activity. Participants will wear a wrist device to track steps and sleep, use a study app, and may receive coaching or home health devices. The goal is to see if these tools can reduce obesity and improve cardiovascular health in communities with limited resources.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 325 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2018
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 75 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Individuals eligible for this protocol have overweight or obesity (BMI \>= 25 kg/m\^2) 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 heart failure, recent unintentional weight loss or physical limitation, that might prohibit safe participation in physical activity for any reason * Heart disease as indicated by history of myocardial infarction in past 1 year, documented obstructive coronary artery disease on coronary angiography, coronary artery stent placement within the last year significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy with EF \<35%, severe valvular heart disease) with evidence of decompensation. * Pregnant women due to large hormonal changes during pregnancy that affect study variables and potential pregnancy-related restrictions on exercise. All participants of childbearing potential will need to self-report a negative pregnancy at the screening visit, baseline visit, and at the three-month and six-month visits, unless the participant self-reports being postmenopausal, having had a tubal ligation, or having undergone a complete hysterectomy. Pilot Study INCLUSION CRITERIA: * Must be an African-American female * Must be within the age of 21-75 years old * Must have overweight or obesity (Body Mass Index (BMI) \>= 25 kg/m\^2) * 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 Eligibility for Post-Menopausal Status for Sleep Sub-study: Eligibility is limited to post-menopausal women who have either completed or are currently enrolled in the main study. Confirmation of post-menopausal status will be determined by review of medical history prior to final eligibility assessment for the study. In patients with prior hysterectomy and retained ovaries, menopause cannot be diagnosed using menstrual criteria. Diagnosis will be made clinically based on age consistent with natural menopause ( \>=45) and the presence of menopausal symptoms, such as vasomotor or genitourinary symptoms. In addition to the Step it Up Study's exclusion criteria, during the screening visit, which can happen by telephone or telehealth, participants will be asked for certain conditions such as bilateral arm deformity, significant peripheral vascular disease, lymphedema, an arteriovenous (AV) fistula or graft in the monitoring arm, severe skin conditions or wounds at the cuff site, inability to tolerate cuff inflation, severe blood disorder or coagulopathy, and any other condition deemed unsafe at the discretion of the principal investigator. Additionally, participants will not be eligible for the optional Sleep Sub-study if: * they are unwilling or unable to be evaluated and followed as clinically indicated (examples might include participants with severe behavioral problems who refuse physical examination). * they do not have a primary healthcare provider or do not accept recommendations provided by study team for provider resources / referral networks. * they have a chronic or acute medical condition severe enough to interfere with overnight sleep study acquisition, such as a tracheotomy, uncontrolled seizure disorder, ventilator dependency, or history of stroke or major neurologic insult. * they work night shift. * they have started any new medications that modify sleep within the last two weeks. Optional MRI Tests Subjects will be screened for implanted metal objects or devices that may be incompatible with MRI (i.e. cerebral aneurysm clip, cochlear implant, pacemaker, etc.) These subjects will be eligible to proceed with study enrollment but will not undergo the optional MRI study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obesity are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?
- Can a cold cloth on the neck calm Post-Surgery nausea?