B'More for a Peaceful Motherhood Hypertension Control Study

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Terminated

CT.gov ID

NCT03741608

Collaborator

(none)

Enrollment

Locations

Arms

14.3

Actual Duration (Months)

5.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Behavioral: High blood pressure management education Behavioral: Home blood pressure measurement	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 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 monthsTwo 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 :

Jan 22, 2019

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Blood pressure reduction [6 months]
decrease in systolic and diastolic blood pressure by 10 points each

Secondary Outcome Measures

Stress [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 44 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Hypertension
Age 18-44
African-American
Female

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leonard E. Hicks Community Center	Baltimore	Maryland	United States	21216
2	Furman L. Templeton Preparatory Academy	Baltimore	Maryland	United States	21217
3	Pedestal Gardens Apartment Homes	Baltimore	Maryland	United States	21217
4	Union Baptist Harvey Johnson Head Start Program	Baltimore	Maryland	United States	21217

Sponsors and Collaborators

University of Maryland, Baltimore

Investigators

Principal Investigator: Wendy G Lane, MD, MPH, University of Maryland, College Park

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wendy Lane, Associate Professor, University of Maryland, Baltimore

ClinicalTrials.gov Identifier:

NCT03741608

Other Study ID Numbers:

HP-00082822

First Posted:

Nov 15, 2018

Last Update Posted:

Apr 14, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypertension

Study Results

No Results Posted as of Apr 14, 2021