Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot

NCT ID: NCT02214459

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-08-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mhealth counseling

DASH Mobile mhealth enhanced coaching

Group Type: EXPERIMENTAL

DASH Mobile mhealth enhanced coaching

Intervention Type: BEHAVIORAL

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

Interventions

DASH Mobile mhealth enhanced coaching

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• hypertension
• prehypertension
• smartphone
• english speaking

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boston University Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-32775

Identifier Type: -

Identifier Source: org_study_id