Minding GOALS: An Internet-Assisted Mind-Body-Behavior Program for Blood Pressure Control

NCT02694432 | Completed

• 2 other identifiers: PRO15120045R34HL123500-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

high blood pressure, systolic, diastolic; complementary therapies, meditation

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure and diastolic blood pressure (mm Hg)

  Change in blood pressure

  Baseline, 4- and 12-months

Secondary Outcomes (10)

• Change in sodium excretion (mmol/24 hr.)

  Baseline and 12-months

• Body weight (kg)

  Baseline, 4- and 12-months

• Body Mass Index (kg/m2)

  Baseline, 4- and 12-months

• Physical activity (steps/day)

  Baseline, 4- and 12-months

• Health-related quality of life

  Baseline, 4- and 12-months

Study Arms (2)

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.

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.

Behavioral: GOALS; Behavioral: Minding GOALS

Interventions

GOALS BEHAVIORAL

16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.

GOALS; Minding GOALS

Minding GOALS BEHAVIORAL

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.

Also known as: Stress reduction

Minding GOALS

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Current pregnancy or planned pregnancy within the next year
• A prior diagnosis of post-traumatic stress disorder
• Prior use of GOALS

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Center for Research on Health Care, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

• 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.

  PMID: 19919191 BACKGROUND

• McTigue 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.

  PMID: 21459256 BACKGROUND

• McTigue 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.

  PMID: 23098133 BACKGROUND

• Morone 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.

  PMID: 17544212 BACKGROUND

• Morone 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.

  PMID: 18550444 BACKGROUND

• Simkin-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.

  PMID: 21421991 BACKGROUND

• Morone 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.

  PMID: 22115971 BACKGROUND

MeSH Terms

Conditions

Hypertension; Systolic Murmurs; Heart Murmurs

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Natalia Morone, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Kathleen M McTigue, MD, MS, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine & Clinical and Translational Science

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: February 29, 2016
• Study Start: September 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)