B'More for a Peaceful Motherhood Hypertension Control Study

Hypertension Clinical Trial

Official title:

A Mindfulness and Behavioral Intervention for Reducing Hypertension Among Women of Childbearing Age

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03741608
• Other study ID #: HP-00082822
• Status: Terminated
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2021
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Hypertension

• Age 18-44

• African-American

• Female

Exclusion Criteria:

• Male

• Age <18 or >44

• Non-African American

• Not female

• Pregnant

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Furman L. Templeton Preparatory Academy	Baltimore	Maryland
United States	Leonard E. Hicks Community Center	Baltimore	Maryland
United States	Pedestal Gardens Apartment Homes	Baltimore	Maryland
United States	Union Baptist Harvey Johnson Head Start Program	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure reduction	decrease in systolic and diastolic blood pressure by 10 points each	6 months
Secondary	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.	6 months