Skip to content

B'More for a Peaceful Motherhood Hypertension Control Study

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03741608
Enrollment
23
Registered
2018-11-15
Start date
2019-01-22
Completion date
2020-04-01
Last updated
2021-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

BEHAVIORALHigh 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.

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

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure reduction6 monthsdecrease in systolic and diastolic blood pressure by 10 points each

Secondary

MeasureTime frameDescription
Stress6 monthsScore 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026