Clinical trial NCT03741608: 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
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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 months
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Blood pressure reduction
timeFrame: 6 months
Secondary outcomes:
measure: Stress
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Leonard E. Hicks Community Center
state: Maryland
city: Baltimore
country: United States
facility: Furman L. Templeton Preparatory Academy
state: Maryland
city: Baltimore
country: United States
facility: Pedestal Gardens Apartment Homes
state: Maryland
city: Baltimore
country: United States
facility: Union Baptist Harvey Johnson Head Start Program
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Wendy G Lane, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: