HypertensionDASH MobileNCT02214459
Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot
A study testing DASH Mobile mhealth enhanced coaching in people with Hypertension, run by Boston University at 1 site in United States.
Trial summary
The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk interventions. The DASH program of diet and exercise based lifestyle change is the most well-established, evidence-based behavioral intervention to control HTN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- DASH Mobile mhealth enhanced coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypertension
- prehypertension
- smartphone
- english speaking
Who cannot join
- on more than 1 medicine for hypertension
- live outside Boston metro area
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk interventions. The DASH program of diet and exercise based lifestyle change is the most well-established, evidence-based behavioral intervention to control HTN. Its recommendations are central to HTN control national guidelines and consumer health products aimed at behavioral management of HTN. However, translating these recommendations into population-wide, inexpensive, sustainable programs have to date proven largely unrealized. The objective of the proposed study is to determine the efficacy of a HTN intervention behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about the DASH diet, physical activity and HTN related behaviors from health coaches trained in evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity and 2) a web-based coaching portal through which health coaches view and respond to patients' behavioral data and assist them in setting goals for changing behaviors consistent with their HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine improvement from baseline to 3-month follow-up in physiological (blood pressure, weight); behavioral (diet \& physical activity); and psychological (e.g., quality of life) measures over a 3-month intervention. Completing this research will result in preliminary feasibility and efficacy data for a larger randomized efficacy trial.
- Conditions
- Hypertension
- Being tested
- DASH Mobile mhealth enhanced coaching
- Keywords
- mHealth, Hypertension, Mobile, smartphone, diet, lifestyle, bluetooth, physical acitvity, behavior change, motivational interviewing
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH Mobile mhealth enhanced coachingBehavioural
Phone calls with a health coach that utilize the tracking data collected by the app and devices.
| Study group | Role | What they receive |
|---|---|---|
| mhealth counseling | Experimental | DASH Mobile mhealth enhanced coaching Receives: Behavioral: DASH Mobile mhealth enhanced coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure reduction
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214459
- Sponsor's protocol ID
- H-32775
- Acronym
- DASH Mobile
- Status last verified
- Mar 2017
- First submitted
- 11 Aug 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot
- ClinicalTrials.gov ID
- NCT02214459
- Acronym / sponsor ID
- DASH Mobile / H-32775
- Conditions
- Hypertension
- Keywords
- mHealth, Hypertension, Mobile, smartphone, diet, lifestyle, bluetooth, physical acitvity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk interventions. The DASH program of diet and exercise based lifestyle change is the most well-established, evidence-based behavioral intervention to control HTN. Its recommendations are central to HTN control national guidelines and consumer health products aimed at behavioral management of HTN. However, translating these recommendations into population-wide, inexpensive, sustainable programs have to date proven largely unrealized. The objective of the proposed study is to determine the efficacy of a HTN intervention behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about the DASH diet, physical activity and HTN related behaviors from health coaches trained in evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity and 2) a web-based coaching portal through which health coaches view and respond to patients' behavioral data and assist them in setting goals for changing behaviors consistent with their HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine improvement from baseline to 3-month follow-up in physiological (blood pressure, weight); behavioral (diet \& physical activity); and psychological (e.g., quality of life) measures over a 3-month intervention. Completing this research will result in preliminary feasibility and efficacy data for a larger randomized efficacy trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mhealth counseling | Experimental | Behavioral: DASH Mobile mhealth enhanced coachingDASH Mobile mhealth enhanced coaching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hypertension
- prehypertension
- smartphone
- english speaking
Key exclusion criteria (2 listed)
- on more than 1 medicine for hypertension
- live outside Boston metro area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH Mobile mhealth enhanced coachingPhone calls with a health coach that utilize the tracking data collected by the app and devices. | Behavioural | mhealth counseling |
Primary outcome
Blood pressure reduction
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH Mobile mhealth enhanced coaching in people with Hypertension, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure reduction (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.