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N/A N=203 Randomized Prevention

Interactive Web Program and Health Coaching for Prehypertensive Adults

Weight · Blood Pressure

Enrolled (actual)
203
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Systolic Blood Pressure — 128.99; 131.4; 131.21; 127.45 mm Hg

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
BlipHub mobile-web app (Behavioral); BlipHub mobile-web app + health coaching (Behavioral); Usual care (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oregon Center for Applied Science, Inc.
Primary completion
Mar 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Systolic Blood Pressure
128.99; 131.4; 131.21; 127.45; 130.40; 130.00
PRIMARY
Diastolic Blood Pressure
76.95; 80.48; 77.83; 75.78; 76.80; 77.55
PRIMARY
Body Weight
187.21; 196.65; 187.60; 187.61; 194.58; 194.05
PRIMARY
Heart-healthy Dietary Intake (Number of Fruit/Vegetable Servings, White Meat Servings, Low-fat Dairy Servings)
5.98; 6.10; 5.85; 5.22; 6.22; 4.87
PRIMARY
Heart-unhealthy Dietary Intake (Self-reported Number of Fat Servings, Red Meat Servings, Dairy Fat Servings)
4.94; 4.54; 5.15; 4.33; 3.70; 4.12
SECONDARY
Self-reported Lifestyle Change Preparation Behaviors
2.70; 2.52; 2.48; 2.78; 2.88; 2.48
SECONDARY
Self-reported Self-efficacy for Lifestyle Behaviors
4.06; 4.10; 3.97; 3.67; 3.87; 3.65

Summary

This project will develop and evaluate an interactive blood pressure self-management program for adults with prehypertension. The program will target blood pressure self-monitoring and the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and alcohol consumption. The multi-modal program uses a combination of brief motivational health coaching, periodic engagement emails, and a robust interactive website to motivate people to take charge of their blood pressure management before they require medication. All program components were designed to conform to the underlying principles of motivational interviewing. Key program components include the use of email and Web-based social networking, personal stories, and a brief motivational coaching session to engage participants and encourage intrinsically motivated behavior changes. Self-assessment and tracking tools are combined with educational content to help participants align their daily lifestyle choices with their personal goals. The Phase I prototype program promoted moderate physical activity and eating fruits and vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in physical activity. Participants gave the online program high ratings on satisfaction and usability, and reported improvements in confidence, readiness, clarity, change strategies, and interest in visiting the Website as a result of the coaching session. The fully developed Phase II product will be evaluated in a large randomized trial (N = 450) with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month follow-up period. The Phase II trial is expected to show reductions in blood pressure and improvements in JNC-recommended health behaviors. These changes in the outcome measures are expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral intention, motivation, and patient activation.

Eligibility Criteria

Inclusion Criteria

  • Blood pressure in the JNC-7-defined prehypertension range (SBP 120-139 and/or DBP 80-89)
  • Must be at least 18 years old
  • Must be employed at least part time
  • Must have access to the internet through a WIFI connection in a place where subject was willing to take BP and weight measurements
  • Must be the only participant per household in the study

Exclusion Criteria

  • Female subjects must not be pregnant or planning to get pregnant over the course of study
  • Must not have experienced a stroke, heart attack, or heart disease diagnosis in the prior six months
  • Must not be taking antihypertensive medications for any reason
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02637063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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