Fight Hypertension in the Digital Age

NCT03659656 | Unknown DMC

• 1 other identifier: 19-0051
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Pre Hypertension; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline daily steps and moderate and vigorous physical activity minutes at 3 months

  Daily steps and moderate and vigorous physical activity minutes will be measured by ActiGraph GT3X+ for 7 days at the baseline and post-intervention at 3 months.

  The primary outcome will be measured twice, one at baseline and another one at approximately one week prior to the final visit (~3 months after the start of the intervention).

Secondary Outcomes (4)

• Change from baseline self-efficacy (sticking to it and making time for exercise)

  The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention.

• Change from baseline self-regulation (time-management, goal-setting, relapse prevention, self-monitoring, reinforcement, and social support)

  The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention.

• Change from baseline social support (family participation, family rewards and punishment, and friend participation)

  The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention.

• Change from baseline self-motivation

  The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention.

Study Arms (2)

Fitbit (FB)

OTHER

The Fitbit only (FB) group will receive the Fitbit monitor to use for 3 months.

Device: Fitbit usage

Fitbit + Health coaching (FB+)

EXPERIMENTAL

The Fitbit + Health coaching (FB+) group will receive a Fitbit, weekly personalized physical activity report and health coaching by phone. The 3-month intervention will be delivered through health coaching (1-time per week for month 1, 1-time every other week for month 2 and 1 time for month 3) and use of a Fitbit activity monitor.

Behavioral: Lifestyle coaching; Device: Fitbit usage

Interventions

Lifestyle coaching BEHAVIORAL

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.

Also known as: Fitbit Charge HR

Fitbit + Health coaching (FB+)

Fitbit usage DEVICE

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

Fitbit (FB); Fitbit + Health coaching (FB+)

Eligibility Criteria

• Age: 24 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between the ages of 24-60.
• Willing to wear a Fitbit monitor for a period of 3 months.
• Able to read and speak English.
• Have a computer and/or smartphone and internet access to be able to make use of the Fitbit.
• Pre- and/or hypertension: systolic blood pressure \>120mmHg or diastolic blood pressure \>80mmHg. Not taking medication: If an individual has systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg they will not be allowed to participate without approval from their physician. Currently taking medication: they will need to provide a physician's note to participate.
• Inactive: less than 150 min/week of exercise over the past 3 months and not currently participating in a structured exercise program.

You may not qualify if:

• Individuals who are currently using a Fitbit or similar monitoring device to track their physical activity.
• Individuals with injuries or conditions that prevent them from safely participating in physical activity
• cardiovascular or cerebrovascular disease
• Cancer, requiring treatment in the past 5 years
• Other medical condition that is life-threatening or can interfere with or be aggravated by participating in physical activity

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yang Bai, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Bai, PhD

CONTACT

802-656-8146; Yang.Bai@med.uvm.edu

Nancy Gell, PhD

CONTACT

802-656-9265; Nancy.Gell@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 6, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: August 1, 2020
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (1)