Hypertension Clinical Trial
Official title:
Fight Hypertension in the Digital Age
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | August 2020 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont | Burlington | Vermont |
Lead Sponsor | Collaborator |
---|---|
University of Vermont |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change from baseline self-efficacy (sticking to it and making time for exercise) | Self-efficacy for exercise will be assessed at the baseline and post-intervention at 3 months.There are two scales of this survey, Sticking to it and Making time for exercise. The range of two scales are 1 to 5. Higher values represent better outcome. | The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention. | |
Secondary | Change from baseline self-regulation (time-management, goal-setting, relapse prevention, self-monitoring, reinforcement, and social support) | Six aspects of self-regulation are measured with the Physical Activity Self-Regulation instrument (PASR-12) including time-management, goal-setting, relapse prevention, self-monitoring, reinforcement, and social support. The instrument contains 12 measures on a 5 point Likert-type scale ranging from 1=never to 5=very often. The self-regulation score is calculated as the sum of the 12 responses. The minimum possible score is 12 and the maximum possible score is 60 with a higher score indicating more frequent use of self-regulation strategies for participation in physical activity. | The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention. | |
Secondary | Change from baseline social support (family participation, family rewards and punishment, and friend participation) | Social support for exercise will be measured using the "Social Support and Exercise Survey," a 13-item questionnaire to measure three factors: family participation, family rewards and punishment, and friend participation. Answers range from 1-5 representing none, rarely, a few times, often, and very often or "does not apply." The potential score ranges from 10-50 for both family participation and friend participation, and from 3-15 for family rewards and punishment for a total potential score of 23-115. | The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention. | |
Secondary | Change from baseline self-motivation | Self-motivation for exercise will be measure using 'Self-Motivation Inventory', a 40-item questionnaires with answers range from 1-5. The potential score ranges from 40-200, with a high score indicative of high self-motivation. | The secondary outcome will be measured twice, one at baseline and another one at the end of 3 months intervention. |
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