Fight Hypertension in the Digital Age
| Status: | Not yet recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 24 - 60 |
| Updated: | 9/9/2018 |
| Start Date: | October 2018 |
| End Date: | August 2020 |
| Contact: | Yang Bai, PhD |
| Email: | Yang.Bai@med.uvm.edu |
| Phone: | 802-656-8146 |
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.
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.
After potential participants contact the research team, the research team will schedule a
phone screening with them to make sure they meet the criteria. If they pass the phone
screening, visit 1 will be scheduled. If they fail the phone screening, their contact
information and response to the phone screening questions will be destroyed. If an individual
agrees to participate, they will complete the informed consent and they will be assigned a
unique ID number. Eligibility will be first checked. Blood pressure will be measured three
times using an automated blood pressure cuff after participants have been seated and rested
for at least 10 minutes for an accurate reading. For participants who do not take medication
that managing blood pressure, if they have systolic blood pressure <120mmHg or diastolic
blood pressure <80mmHg they will not be allowed to participate. 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. If they are diagnosed with
pre-hypertension or hypertension and are currently taking medication, they will need to
provide a physician's note to participate. They will also be asked to complete a physical
activity measure, the International Physical Activity Questionnaire (IPAQ) to assess their
activity over the last week. If they accumulated more than 150 minutes of moderate and
vigorous physical activity per week, they will not be eligible to participate. This will be
checked by a member of the research team to ensure that they are eligible to participate. If
the person meets criteria (other inclusion and exclusion criteria information is listed below
separately in Inclusion/Exclusion section), they will be provided with additional information
about the study and be guided through the Visit 1 data collection protocol and be informed
about plans for Visit 2 (1 week later) and Visit 3 (approximately 3 months later). The visits
will last about 60 minutes each, with Visit 2 being up to 90 minutes for participants
randomly assigned to the Fitbit + Behavior Change Strategies (FB+) condition described below.
Visit 1. Visit 1 will include baseline measurements and providing participants with
information about the monitors that they will wear to assess physical activity and sedentary
behaviors at baseline and at the end of the intervention. They will schedule a time to come
back the following week for their second study visit.
Visit 2. At the beginning of Visit 2, participants will be block randomized to their
experimental condition and informed of their condition assignment. Randomization will occur
in blocks of 5 to ensure that groups are experiencing similar environmental (e.g. weather)
variations that may influence physical activity behaviors. Randomization will be done using a
random number generator. Conditions are: use of the Fitbit alone (FB) or use of the Fitbit in
combination with behavior change strategies (FB+). Descriptions of conditions are below.
Regardless of condition, all participants will receive information about the Fitbit and will
be given a guided tour of the device itself and the associated software. Participants will be
given a username and password to be used with the software and will be encouraged to utilize
the software over the next 3 months to assist them in becoming more physically active.
Participants assigned to the FB condition will use their Fitbit on their own for the duration
of 3-month intervention, similar to the experience of participants buying the device
off-the-shelf. Those assigned to the FB+ condition will discuss their perceived benefits and
barriers of becoming more physically active with health coach. Participants will also be
encouraged to set a goal of their choosing related to using their Fitbit to increase their
physical activity. Weekly progress reports will be sent to participants through Email on
Monday. Participants assigned to this group will also receive weekly (first month),
semi-monthly (second month), monthly (third month) phone contact from the health coach to
follow-up on the achievement from previous week(s) and re-evaluate their goals based on their
current behaviors.
Regardless of group assignment, during the 3-month intervention all participants will receive
periodic (~monthly) contacts (via email or phone) from the research team asking how they are
using their Fitbits. For participants in the FB+ group, this contact can be at the same time
as their check-ins. During this monthly contact, participants will be asked open-ended
questions regarding how frequently the Fitbits are being worn, how often participants are
looking at their data, and what aspects of the monitors and associated software/apps are
particularly useful and/or motivating for them. They will be also asked about their physical
health and well beings related to participate in the study as a safety check.
Approximately one week prior to the final visit (~3 months after the start of the
intervention), participants will be asked to come to the lab for a brief visit to pick up an
objective activity monitor (ActiGraph) and to wear them for the next week in order to assess
physical activity and sedentary time at the end of the intervention. At this time,
participants will also be scheduled to return for their final study visit.
Visit 3 will be completed at the end of the 3-month trial. During this visit, participants
will complete the same anthropomorphic, cardiovascular, and psychosocial measures assessed at
baseline. They will be given the opportunity to complete an optional semi-structured
interview with a member of the study team. This brief interview could be done during this
visit or at another time that is convenient for the participant. The purpose of the interview
would be to gather qualitative information from participants regarding their use of the
monitors and factors that facilitated and/or impeded behavior change.
Twelve weeks after the intervention the investigator's will ask participants to complete the
physical activity questionnaire once again to assess for long term changes in self-reported
physical activity and secondary outcome measures.
phone screening with them to make sure they meet the criteria. If they pass the phone
screening, visit 1 will be scheduled. If they fail the phone screening, their contact
information and response to the phone screening questions will be destroyed. If an individual
agrees to participate, they will complete the informed consent and they will be assigned a
unique ID number. Eligibility will be first checked. Blood pressure will be measured three
times using an automated blood pressure cuff after participants have been seated and rested
for at least 10 minutes for an accurate reading. For participants who do not take medication
that managing blood pressure, if they have systolic blood pressure <120mmHg or diastolic
blood pressure <80mmHg they will not be allowed to participate. 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. If they are diagnosed with
pre-hypertension or hypertension and are currently taking medication, they will need to
provide a physician's note to participate. They will also be asked to complete a physical
activity measure, the International Physical Activity Questionnaire (IPAQ) to assess their
activity over the last week. If they accumulated more than 150 minutes of moderate and
vigorous physical activity per week, they will not be eligible to participate. This will be
checked by a member of the research team to ensure that they are eligible to participate. If
the person meets criteria (other inclusion and exclusion criteria information is listed below
separately in Inclusion/Exclusion section), they will be provided with additional information
about the study and be guided through the Visit 1 data collection protocol and be informed
about plans for Visit 2 (1 week later) and Visit 3 (approximately 3 months later). The visits
will last about 60 minutes each, with Visit 2 being up to 90 minutes for participants
randomly assigned to the Fitbit + Behavior Change Strategies (FB+) condition described below.
Visit 1. Visit 1 will include baseline measurements and providing participants with
information about the monitors that they will wear to assess physical activity and sedentary
behaviors at baseline and at the end of the intervention. They will schedule a time to come
back the following week for their second study visit.
Visit 2. At the beginning of Visit 2, participants will be block randomized to their
experimental condition and informed of their condition assignment. Randomization will occur
in blocks of 5 to ensure that groups are experiencing similar environmental (e.g. weather)
variations that may influence physical activity behaviors. Randomization will be done using a
random number generator. Conditions are: use of the Fitbit alone (FB) or use of the Fitbit in
combination with behavior change strategies (FB+). Descriptions of conditions are below.
Regardless of condition, all participants will receive information about the Fitbit and will
be given a guided tour of the device itself and the associated software. Participants will be
given a username and password to be used with the software and will be encouraged to utilize
the software over the next 3 months to assist them in becoming more physically active.
Participants assigned to the FB condition will use their Fitbit on their own for the duration
of 3-month intervention, similar to the experience of participants buying the device
off-the-shelf. Those assigned to the FB+ condition will discuss their perceived benefits and
barriers of becoming more physically active with health coach. Participants will also be
encouraged to set a goal of their choosing related to using their Fitbit to increase their
physical activity. Weekly progress reports will be sent to participants through Email on
Monday. Participants assigned to this group will also receive weekly (first month),
semi-monthly (second month), monthly (third month) phone contact from the health coach to
follow-up on the achievement from previous week(s) and re-evaluate their goals based on their
current behaviors.
Regardless of group assignment, during the 3-month intervention all participants will receive
periodic (~monthly) contacts (via email or phone) from the research team asking how they are
using their Fitbits. For participants in the FB+ group, this contact can be at the same time
as their check-ins. During this monthly contact, participants will be asked open-ended
questions regarding how frequently the Fitbits are being worn, how often participants are
looking at their data, and what aspects of the monitors and associated software/apps are
particularly useful and/or motivating for them. They will be also asked about their physical
health and well beings related to participate in the study as a safety check.
Approximately one week prior to the final visit (~3 months after the start of the
intervention), participants will be asked to come to the lab for a brief visit to pick up an
objective activity monitor (ActiGraph) and to wear them for the next week in order to assess
physical activity and sedentary time at the end of the intervention. At this time,
participants will also be scheduled to return for their final study visit.
Visit 3 will be completed at the end of the 3-month trial. During this visit, participants
will complete the same anthropomorphic, cardiovascular, and psychosocial measures assessed at
baseline. They will be given the opportunity to complete an optional semi-structured
interview with a member of the study team. This brief interview could be done during this
visit or at another time that is convenient for the participant. The purpose of the interview
would be to gather qualitative information from participants regarding their use of the
monitors and factors that facilitated and/or impeded behavior change.
Twelve weeks after the intervention the investigator's will ask participants to complete the
physical activity questionnaire once again to assess for long term changes in self-reported
physical activity and secondary outcome measures.
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
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