B'More for a Peaceful Motherhood Hypertension Control Study

NCT ID: NCT03741608

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2020-04-01

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.

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Education, BP cuff & training

High blood pressure management education. Home blood pressure measurement

Group Type: ACTIVE_COMPARATOR

High blood pressure management education

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Education only

High blood pressure management education

Group Type: ACTIVE_COMPARATOR

High blood pressure management education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Wendy Lane

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wendy G Lane, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Leonard E. Hicks Community Center

Baltimore, Maryland, United States

Furman L. Templeton Preparatory Academy

Baltimore, Maryland, United States

Pedestal Gardens Apartment Homes

Baltimore, Maryland, United States

Union Baptist Harvey Johnson Head Start Program

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00082822

Identifier Type: -

Identifier Source: org_study_id