B'More for a Peaceful Motherhood Hypertension Control Study

NCT03741608 | Terminated

• 1 other identifier: HP-00082822
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood pressure reduction

  decrease in systolic and diastolic blood pressure by 10 points each

  6 months

Secondary Outcomes (1)

• Stress

  6 months

Study Arms (2)

Education, BP cuff & training

ACTIVE COMPARATOR

High blood pressure management education. Home blood pressure measurement

Behavioral: High blood pressure management education; Behavioral: Home blood pressure measurement

Education only

ACTIVE COMPARATOR

High blood pressure management education

Behavioral: High blood pressure management education

Interventions

High blood pressure management education 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.

Education only; Education, BP cuff & training

Home blood pressure measurement 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, BP cuff & training

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (4)

Leonard E. Hicks Community Center

Baltimore, Maryland, 21216, United States

Location

Furman L. Templeton Preparatory Academy

Baltimore, Maryland, 21217, United States

Location

Pedestal Gardens Apartment Homes

Baltimore, Maryland, 21217, United States

Location

Union Baptist Harvey Johnson Head Start Program

Baltimore, Maryland, 21217, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wendy G Lane, MD, MPH

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: November 15, 2018
• Study Start: January 22, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)