search
Back to results

B'More for a Peaceful Motherhood Hypertension Control Study

Primary Purpose

Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High blood pressure management education
Home blood pressure measurement
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Leonard E. Hicks Community Center
  • Furman L. Templeton Preparatory Academy
  • Pedestal Gardens Apartment Homes
  • Union Baptist Harvey Johnson Head Start Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Education, BP cuff & training

Education only

Arm Description

High blood pressure management education. Home blood pressure measurement

High blood pressure management education

Outcomes

Primary Outcome Measures

Blood pressure reduction
decrease in systolic and diastolic blood pressure by 10 points each

Secondary Outcome Measures

Stress
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.

Full Information

First Posted
November 12, 2018
Last Updated
April 9, 2021
Sponsor
University of Maryland, Baltimore
search

1. Study Identification

Unique Protocol Identification Number
NCT03741608
Brief Title
B'More for a Peaceful Motherhood Hypertension Control Study
Official Title
A Mindfulness and Behavioral Intervention for Reducing Hypertension Among Women of Childbearing Age
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID prevented us from continuing recruitment and interventions at community sites
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education, BP cuff & training
Arm Type
Active Comparator
Arm Description
High blood pressure management education. Home blood pressure measurement
Arm Title
Education only
Arm Type
Active Comparator
Arm Description
High blood pressure management education
Intervention Type
Behavioral
Intervention Name(s)
High blood pressure management education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home blood pressure measurement
Intervention Description
Participants will be taught to use an automated blood pressure cuff and will be asked to provide monthly blood pressure readings to study staff.
Primary Outcome Measure Information:
Title
Blood pressure reduction
Description
decrease in systolic and diastolic blood pressure by 10 points each
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Stress
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hypertension Age 18-44 African-American Female Exclusion Criteria: Male Age <18 or >44 Non-African American Not female Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy G Lane, MD, MPH
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leonard E. Hicks Community Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21216
Country
United States
Facility Name
Furman L. Templeton Preparatory Academy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21217
Country
United States
Facility Name
Pedestal Gardens Apartment Homes
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21217
Country
United States
Facility Name
Union Baptist Harvey Johnson Head Start Program
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21217
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will share blood pressure measurements and Perceived Stress Scale measurements upon request

Learn more about this trial

B'More for a Peaceful Motherhood Hypertension Control Study

We'll reach out to this number within 24 hrs