NCT02214459

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2014

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

August 11, 2014

Last Update Submit

March 21, 2017

Conditions

Keywords

mHealthHypertensionMobilesmartphonedietlifestylebluetoothphysical acitvitybehavior changemotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • Blood pressure reduction

    3 Months

Study Arms (1)

mhealth counseling

EXPERIMENTAL

DASH Mobile mhealth enhanced coaching

Behavioral: DASH Mobile mhealth enhanced coaching

Interventions

Phone calls with a health coach that utilize the tracking data collected by the app and devices.

mhealth counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertension
  • prehypertension
  • smartphone
  • english speaking

You may not qualify if:

  • on more than 1 medicine for hypertension
  • live outside Boston metro area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 12, 2014

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations