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B'More for a Peaceful Motherhood Hypertension Control Study

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ClinicalTrials.gov Identifier: NCT03741608
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Wendy Lane, University of Maryland, College Park

Brief Summary:
This study will assess whether an intervention including mindfulness, dietary education, and smoking cessation can help African-American women of childbearing age (age 18-44) with hypertension or high blood pressure to lower their blood pressure. The investigators propose to screen women of childbearing age for hypertension, and to invite women to participate in an intervention to reduce their blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: High blood pressure management education Behavioral: Home blood pressure measurement Not Applicable

Detailed Description:
Chronic and pregnancy-associated hypertension increase risk for poor birth outcomes, including higher rates of low birthweight and preterm birth. Mindfulness interventions, dietary education, and smoking cessation education have all been effectively employed to reduce hypertension, but have infrequently targeted women of childbearing age in community settings. This study will screen African-American women of childbearing age for hypertension, and invite women with hypertension to participate in a seven-session intervention to reduce blood pressure. The investigators will track their perceived stress and their blood pressure levels over the next 6 months. Half of the women who participate will be given a blood pressure cuff and taught to measure their own blood pressure. More frequent tracking of blood pressure will be done in these women.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups will both participate in the 7-part educational series to reduce high blood pressure. One of the two groups will also be given a blood pressure cuff and will be trained to check their own blood pressure. We will track blood pressure and stress level of both groups for 6 months
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Mindfulness and Behavioral Intervention for Reducing Hypertension Among Women of Childbearing Age
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Education, BP cuff & training
High blood pressure management education. Home blood pressure measurement
Behavioral: High blood pressure management education
The 7-part education series includes 5 sessions focused on mindfulness and breathing techniques for stress reduction. One session will focus on choosing healthy, low salt foods and will provide resources for smoking cessation. The final session will include a grocery store tour to teach participants how to read food labels and to purchase healthy food.

Behavioral: Home blood pressure measurement
Participants will be taught to use an automated blood pressure cuff and will be asked to provide monthly blood pressure readings to study staff.

Active Comparator: Education only
High blood pressure management education
Behavioral: High blood pressure management education
The 7-part education series includes 5 sessions focused on mindfulness and breathing techniques for stress reduction. One session will focus on choosing healthy, low salt foods and will provide resources for smoking cessation. The final session will include a grocery store tour to teach participants how to read food labels and to purchase healthy food.




Primary Outcome Measures :
  1. Blood pressure reduction [ Time Frame: 6 months ]
    decrease in systolic and diastolic blood pressure by 10 points each


Secondary Outcome Measures :
  1. Stress [ Time Frame: 6 months ]
    Score on Perceived Stress Scale. The Perceived Stress Scale (Cohen, S, 1994) is the most widely used psychological instrument for measuring the perception of stress. It is a 10-question survey asking to what degree certain stressors have been a problem in the past month. Responses are recorded on a 5-point Likert scale from 0 (never) to 4 (very often). The 6 negatively-stated items are scored as is, while the four positively stated items' scores are reversed. The total score may therefore range from 0 to 40. Higher scores indicate higher levels of stress (i.e. a worse outcome). There are no subscales.



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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hypertension
  • Age 18-44
  • African-American
  • Female

Exclusion Criteria:

  • Male
  • Age <18 or >44
  • Non-African American
  • Not female
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741608


Contacts
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Contact: Wendy G Lane, MD, MPH 4107067865 wlane@som.umaryland.edu
Contact: Stacey Stephens, MSW 4107066131 sstephens@ssw.umaryland.edu

Locations
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United States, Maryland
Leonard E. Hicks Community Center Recruiting
Baltimore, Maryland, United States, 21216
Contact: Sia Stevenson    410-669-1023    Lehcdc@gmail.com   
Furman L. Templeton Preparatory Academy Recruiting
Baltimore, Maryland, United States, 21217
Contact: Layotis Mackey       latoria.mackey@ssw.umaryland.edu   
Pedestal Gardens Apartment Homes Recruiting
Baltimore, Maryland, United States, 21217
Contact: Meloni Barber    443-790-6303    Meloni.harris.barber@TBCINC.ORG   
Union Baptist Harvey Johnson Head Start Program Recruiting
Baltimore, Maryland, United States, 21217
Contact: Kathleen McElroy    410-706-4804    mcelroy@umaryland.edu   
Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Principal Investigator: Wendy G Lane, MD, MPH University of Maryland, College Park

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Responsible Party: Wendy Lane, Associate Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT03741608     History of Changes
Other Study ID Numbers: HP-00082822
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share blood pressure measurements and Perceived Stress Scale measurements upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases