Fight Hypertension in the Digital Age

NCT03659656 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-09-07

No results posted yet for this study

Summary

The estimated prevalence of hypertension is approximately 29.0% in the United States during 2015-2016. Hypertension remains an important public health challenge in the United States because it increases the risk for other health conditions such as cardiovascular disease. Strong evidence has indicated that physical activity is associated with reduced risk of hypertension. Lifestyle change programs, including physical activity promotion and dietary modification, have been shown to effectively reduce the cumulative incidence of hypertension for individuals at-risk. However, it is challenging to maintain a high-level program. Recently, the consumer marketplace has been flooded with an array of wearable activity monitors, such Fitbit and Apple Watch, designed to enhance real time self-assessment and activity behavior change. These devices provide potential to serve as more cost effective and appealing intervention means for behavior change applications. Studies have examined the accuracy of the devices but little has been done to examine the monitors' feasibility as a behavior change strategy in and of themselves or as an adjunct to traditional methods (e.g., education and goal setting through a health coach), among people with hypertension. The real-time physical activity monitoring also provides an opportunity to build customized physical activity biofeedback for behavior change. Thus, there is an increasing interest to investigate their application as a behavior change strategy in isolation or as a complement to a more traditional intervention. The current study will recruit participants with hypertension and pre-hypertension. A Fitbit Charge HR will be provided to use over the intervention to all participants. They will be randomly assigned into Fitbit only and Fitbit plus (adding weekly personalized report and health coach consulting) groups for 3-months.

Conditions

Interventions

BEHAVIORAL

Lifestyle coaching

Goal setting and behavior change barriers will be discussed through lifestyle behavioral change coaching. Personalized weekly physical activity achievement report will also be sending to participants in experimental group. The participants will also have a Fitbit to use for 3 months.

DEVICE

Fitbit usage

The participants will have a Fitbit to use for 3 months.

Sponsors & Collaborators

  • University of Vermont

    lead OTHER

Principal Investigators

  • Yang Bai, PhD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-12-31
Completion
2020-08-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03659656 on ClinicalTrials.gov