HypertensionNCT02694432
Minding GOALS: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
A study testing GOALS and Minding GOALS in people with Hypertension, run by University of Pittsburgh at 1 site in United States.
Trial summary
This pilot study will evaluate the feasibility of adding an online mind-body-behavior program to an existing behavioral self-management support platform that has been modified to promote achievement of blood pressure goals. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Hypertension
- What is being tested?
- GOALS and Minding GOALS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic blood pressure >/= 150 mmHg and/or
- Diastolic blood pressure >/= 90 mmHg and
- At least one other cardiovascular disease (CVD) risk factor (i.e., diabetes, dyslipidemia, family history of premature CVD, current smoking, obesity)
Who cannot join
- Known secondary hypertension of any etiology, malignant hypertension or hypertensive encephalopathy
- Severe edema
- A primary care physician (PCP) of the opinion that the patient is unable to safely undertake moderately intense unsupervised physical activity (equivalent of 30 minutes brisk walking)
- A PCP of the opinion that the patient has inadequate cognitive function to participate
- Previous participation in a mindfulness meditation program
- An inability to learn adequately from English language materials
Show all 9Show fewer
- Current pregnancy or planned pregnancy within the next year
- A prior diagnosis of post-traumatic stress disorder
- Prior use of GOALS
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research on Health Care, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
This pilot study will evaluate the feasibility of adding an online mind-body-behavior program to an existing behavioral self-management support platform that has been modified to promote achievement of blood pressure goals.
Read the detailed description
Efficacious hypertension therapies are well-documented, yet 40% of treated patients do not meet the blood pressure goals set by the Joint National Committee. This gap between scientific evidence and clinical outcomes in part reflects low patient adherence to lifestyle recommendations (e.g., physical activity, weight and diet), as well as medication non-adherence. Accordingly, growing attention is focused on the need to provide patients with effective self-management support tools. In addition to finding ways to help patients adhere to currently prescribed hypertension care, it is useful to consider the range of treatment options that are offered. Evidence-based reviews have identified stress reduction as an effective tool for reducing blood pressure, yet such approaches are typically not implemented in practice. This omission represents a chance to improve the quality of hypertension care by adding stress management self-management tools. Furthermore, since patients have demonstrated a clear interest in mindfulness, the incorporation of a holistic mind-body intervention is an innovative approach to inherently patient-centered care. Increasing data supports the use of mindfulness for treating health concerns. Its holistic nature may be particularly well-suited to developing and maintaining healthy lifestyles, since lifestyle impacts diverse aspects of physical and psychological health. Yet the potential for mindfulness in health self-management has not been realized.
Limited but promising data demonstrate the effectiveness of web-based counseling for behavior modification to improve common chronic disease risk factors. It is an ideal solution to provider time constraints and a potential solution to patient non-adherence to lifestyle recommendations. Health information technology provides a way to make self-management support affordable, convenient and feasible. The investigators have developed a convenient behavioral self-management support platform, "Goal-oriented Online Access to Lifestyle Support" (GOALS) for primary care patients, which has promoted weight loss and improved blood pressure control among primary care patients with weight-related cardiovascular risk factors. To maximize the ability of patients to achieve blood pressure goals, the investigators propose to add an online mind-body-behavior program to GOALS: "Minding GOALS." The investigators will evaluate the feasibility of using this program for self-management support, in coordination with primary care, in a group of 76 patients with uncontrolled hypertension. In preparation for a randomized clinical trial comparing the online tool to online traditional self-management support, the investigators will assess implementation and determine 1) the availability of eligible and willing subjects using the proposed recruitment methods, 2) the feasibility of delivering the proposed interventions in the population of interest, and 3) the viability of the proposed measurement protocols.
- Conditions
- Hypertension
- Being tested
- GOALS, Minding GOALS
- Keywords
- high blood pressure, systolic, diastolic, complementary therapies, meditation
- Medical subject headings
- Hypertension, Systolic Murmurs, Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOALSBehavioural
16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.
Minding GOALSBehavioural
Also called Stress reduction
16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support, coupled with a mind-body-behavior program to further enhance improvements in blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| GOALS | Active comparator | Participants will use for approximately four months an online platform, GOALS, consisting of weekly lessons designed to enhance blood pressure control. Recommended lifestyle changes for hypertension, including a low-sodium diet, physical activity, weight loss (if appropriate) and behavioral self-management skills will be offered. Attention to medication adherence and pharmacist support as well as that of a dedicated online health coach and ongoing collaboration with the primary care physician are also provided. Receives: Behavioral: GOALS |
| Minding GOALS | Experimental | Participants in this arm will also use the GOALS standard tools for blood pressure control. To further maximize success, they will receive additional online behavioral training throughout the 4-month intervention that focuses on mind-body approaches. Weekly topics, for example, will include meditation lessons, mindfulness-based stress reduction and mindfulness-based eating awareness. Receives: Behavioral: GOALS; Behavioral: Minding GOALS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure and diastolic blood pressure (mm Hg)
Change in blood pressure
Measured: Baseline, 4- and 12-months
Secondary outcomes (10)
Change in sodium excretion (mmol/24 hr.)
From 24-hr urine collection
Measured: Baseline and 12-months
Body weight (kg)
Measured: Baseline, 4- and 12-months
Body Mass Index (kg/m2)
Measured: Baseline, 4- and 12-months
Physical activity (steps/day)
Assessed by pedometer
Measured: Baseline, 4- and 12-months
Health-related quality of life
PROMIS (Patient Reported Outcomes Measurement Information System)-29 Profile v2.0
Measured: Baseline, 4- and 12-months
Perceived Stress Scale
Measured: Baseline, 4- and 12-months
PROMIS-29 Profile v2.0
Quality of Life
Measured: Baseline, 4- and 12-months
Mindful Attention Awareness Scale
Assesses a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
Measured: Baseline, 4- and 12-months
Self-reported medication adherence questions
Self-reported scale to measure medication adherence
Measured: Baseline, 4- and 12-months
Credibility/Expectancy Questionnaire
For measuring treatment expectancy and rationale credibility in clinical trials
Measured: Baseline, 4- and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startSep 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Natalia Morone, University of Pittsburgh
- Investigators
- Natalia Morone, MD, MS, Principal investigator, University of PittsburghKathleen M McTigue, MD, MS, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694432
- Sponsor's protocol ID
- PRO15120045
- Other IDs
- R34HL123500-01
- Status last verified
- Jul 2018
- First submitted
- 12 Jan 2016
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
McTigue KM, Conroy MB, Hess R, Bryce CL, Fiorillo AB, Fischer GS, Milas NC, Simkin-Silverman LR. Using the internet to translate an evidence-based lifestyle intervention into practice. Telemed J E Health. 2009 Nov;15(9):851-8. doi: 10.1089/tmj.2009.0036.
PubMed 19919191McTigue KM, Bhargava T, Bryce CL, Conroy M, Fischer GS, Hess R, Simkin-Silverman LR, Zickmund S. Patient perspectives on the integration of an intensive online behavioral weight loss intervention into primary care. Patient Educ Couns. 2011 May;83(2):261-4. doi: 10.1016/j.pec.2010.05.009. Epub 2010 Jun 17.
PubMed 21459256McTigue KM, Conroy MB. Use of the internet in the treatment of obesity and prevention of type 2 diabetes in primary care. Proc Nutr Soc. 2013 Feb;72(1):98-108. doi: 10.1017/S0029665112002777. Epub 2012 Oct 26.
PubMed 23098133Morone NE, Greco CM, Weiner DK. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study. Pain. 2008 Feb;134(3):310-319. doi: 10.1016/j.pain.2007.04.038. Epub 2007 Jun 1.
PubMed 17544212Morone NE, Lynch CS, Greco CM, Tindle HA, Weiner DK. "I felt like a new person." the effects of mindfulness meditation on older adults with chronic pain: qualitative narrative analysis of diary entries. J Pain. 2008 Sep;9(9):841-8. doi: 10.1016/j.jpain.2008.04.003. Epub 2008 Jun 12.
PubMed 18550444Simkin-Silverman LR, Conroy MB, Bhargava T, McTigue KM. Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Diabetes Educ. 2011 Mar-Apr;37(2):263-8. doi: 10.1177/0145721710396587.
PubMed 21421991Morone NE, Greco CM, Rollman BL, Moore CG, Lane B, Morrow L, Glynn NW, Delaney J, Albert SM, Weiner DK. The design and methods of the aging successfully with pain study. Contemp Clin Trials. 2012 Mar;33(2):417-25. doi: 10.1016/j.cct.2011.11.012. Epub 2011 Nov 15.
PubMed 22115971
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control
- ClinicalTrials.gov ID
- NCT02694432
- Acronym / sponsor ID
- PRO15120045
- Conditions
- Hypertension
- Keywords
- high blood pressure, systolic, diastolic, complementary therapies, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2016
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 29 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will evaluate the feasibility of adding an online mind-body-behavior program to an existing behavioral self-management support platform that has been modified to promote achievement of blood pressure goals.
Detailed description
Efficacious hypertension therapies are well-documented, yet 40% of treated patients do not meet the blood pressure goals set by the Joint National Committee. This gap between scientific evidence and clinical outcomes in part reflects low patient adherence to lifestyle recommendations (e.g., physical activity, weight and diet), as well as medication non-adherence. Accordingly, growing attention is focused on the need to provide patients with effective self-management support tools. In addition to finding ways to help patients adhere to currently prescribed hypertension care, it is useful to consider the range of treatment options that are offered. Evidence-based reviews have identified stress reduction as an effective tool for reducing blood pressure, yet such approaches are typically not implemented in practice. This omission represents a chance to improve the quality of hypertension care by adding stress management self-management tools. Furthermore, since patients have demonstrated a clear interest in mindfulness, the incorporation of a holistic mind-body intervention is an innovative approach to inherently patient-centered care. Increasing data supports the use of mindfulness for treating health concerns. Its holistic nature may be particularly well-suited to developing and maintaining healthy lifestyles, since lifestyle impacts diverse aspects of physical and psychological health. Yet the potential for mindfulness in health self-management has not been realized.
Limited but promising data demonstrate the effectiveness of web-based counseling for behavior modification to improve common chronic disease risk factors. It is an ideal solution to provider time constraints and a potential solution to patient non-adherence to lifestyle recommendations. Health information technology provides a way to make self-management support affordable, convenient and feasible. The investigators have developed a convenient behavioral self-management support platform, "Goal-oriented Online Access to Lifestyle Support" (GOALS) for primary care patients, which has promoted weight loss and improved blood pressure control among primary care patients with weight-related cardiovascular risk factors. To maximize the ability of patients to achieve blood pressure goals, the investigators propose to add an online mind-body-behavior program to GOALS: "Minding GOALS." The investigators will evaluate the feasibility of using this program for self-management support, in coordination with primary care, in a group of 76 patients with uncontrolled hypertension. In preparation for a randomized clinical trial comparing the online tool to online traditional self-management support, the investigators will assess implementation and determine 1) the availability of eligible and willing subjects using the proposed recruitment methods, 2) the feasibility of delivering the proposed interventions in the population of interest, and 3) the viability of the proposed measurement protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GOALS | Active comparator | Behavioral: GOALSParticipants will use for approximately four months an online platform, GOALS, consisting of weekly lessons designed to enhance blood pressure control. Recommended lifestyle changes for hypertension, including a low-sodium diet, physical activity, weight loss (if appropriate) and behavioral self-management skills will be offered. Attention to medication adherence and pharmacist support as well as that of a dedicated online health coach and ongoing collaboration with the primary care physician are also provided. |
| Minding GOALS | Experimental | Behavioral: GOALS, Behavioral: Minding GOALSParticipants in this arm will also use the GOALS standard tools for blood pressure control. To further maximize success, they will receive additional online behavioral training throughout the 4-month intervention that focuses on mind-body approaches. Weekly topics, for example, will include meditation lessons, mindfulness-based stress reduction and mindfulness-based eating awareness. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Systolic blood pressure >/= 150 mmHg and/or
- Diastolic blood pressure >/= 90 mmHg and
- At least one other cardiovascular disease (CVD) risk factor (i.e., diabetes, dyslipidemia, family history of premature CVD, current smoking, obesity)
Key exclusion criteria (9 listed)
- Known secondary hypertension of any etiology, malignant hypertension or hypertensive encephalopathy
- Severe edema
- A primary care physician (PCP) of the opinion that the patient is unable to safely undertake moderately intense unsupervised physical activity (equivalent of 30 minutes brisk walking)
- A PCP of the opinion that the patient has inadequate cognitive function to participate
- Previous participation in a mindfulness meditation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOALS16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support. | Behavioural | GOALS, Minding GOALS |
| Minding GOALSAlso: Stress reduction16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support, coupled with a mind-body-behavior program to further enhance improvements in blood pressure. | Behavioural | Minding GOALS |
Primary outcome
Change in systolic blood pressure and diastolic blood pressure (mm Hg)
Time frame: Baseline, 4- and 12-months
Change in blood pressure
10 secondary outcomes
Change in sodium excretion (mmol/24 hr.)
Time frame: Baseline and 12-months
Body weight (kg)
Time frame: Baseline, 4- and 12-months
Body Mass Index (kg/m2)
Time frame: Baseline, 4- and 12-months
Physical activity (steps/day)
Time frame: Baseline, 4- and 12-months
Health-related quality of life
Time frame: Baseline, 4- and 12-months
Perceived Stress Scale
Time frame: Baseline, 4- and 12-months
PROMIS-29 Profile v2.0
Time frame: Baseline, 4- and 12-months
Mindful Attention Awareness Scale
Time frame: Baseline, 4- and 12-months
Self-reported medication adherence questions
Time frame: Baseline, 4- and 12-months
Credibility/Expectancy Questionnaire
Time frame: Baseline, 4- and 12-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 19919191McTigue KM, Conroy MB, Hess R, Bryce CL, Fiorillo AB, Fischer GS, Milas NC, Simkin-Silverman LR. Using the internet to translate an evidence-based lifestyle intervention into practice. Telemed J E Health. 2009 Nov;15(9):851-8. doi: 10.1089/tmj.2009.0036.
- Background: PubMed 21459256McTigue KM, Bhargava T, Bryce CL, Conroy M, Fischer GS, Hess R, Simkin-Silverman LR, Zickmund S. Patient perspectives on the integration of an intensive online behavioral weight loss intervention into primary care. Patient Educ Couns. 2011 May;83(2):261-4. doi: 10.1016/j.pec.2010.05.009. Epub 2010 Jun 17.
- Background: PubMed 23098133McTigue KM, Conroy MB. Use of the internet in the treatment of obesity and prevention of type 2 diabetes in primary care. Proc Nutr Soc. 2013 Feb;72(1):98-108. doi: 10.1017/S0029665112002777. Epub 2012 Oct 26.
- Background: PubMed 17544212Morone NE, Greco CM, Weiner DK. Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study. Pain. 2008 Feb;134(3):310-319. doi: 10.1016/j.pain.2007.04.038. Epub 2007 Jun 1.
- Background: PubMed 18550444Morone NE, Lynch CS, Greco CM, Tindle HA, Weiner DK. "I felt like a new person." the effects of mindfulness meditation on older adults with chronic pain: qualitative narrative analysis of diary entries. J Pain. 2008 Sep;9(9):841-8. doi: 10.1016/j.jpain.2008.04.003. Epub 2008 Jun 12.
- Background: PubMed 21421991Simkin-Silverman LR, Conroy MB, Bhargava T, McTigue KM. Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Diabetes Educ. 2011 Mar-Apr;37(2):263-8. doi: 10.1177/0145721710396587.
- Background: PubMed 22115971Morone NE, Greco CM, Rollman BL, Moore CG, Lane B, Morrow L, Glynn NW, Delaney J, Albert SM, Weiner DK. The design and methods of the aging successfully with pain study. Contemp Clin Trials. 2012 Mar;33(2):417-25. doi: 10.1016/j.cct.2011.11.012. Epub 2011 Nov 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Morone, MD, MS principal investigator
University of Pittsburgh
Kathleen M McTigue, MD, MS, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOALS and Minding GOALS in people with Hypertension, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure and diastolic blood pressure (mm Hg) (time frame: Baseline, 4- and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02694432, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.