CLINICAL TRIAL

Alternative Lifestyle Interventions in Vulnerable Ethnic groups for Hypertension

Waitlist Available · 18+ · Female · Nashville, TN

Mobilizing Doulas to Empower Black Women in Post-partum Diabetes Prevention

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About the trial for Hypertension

Eligible Conditions
Type2 Diabetes · Eclampsia · Pregnancy Complications · Diabetes, Gestational · Essential Hypertension · Gestational Diabetes Mellitus (GDM) · Hypertension · Primary Hypertension After Pregnancy · Diabetes Mellitus · Pre-Eclampsia · Chronic Hypertension Complicating Pregnancy · Obesity

Treatment Groups

This trial involves 4 different treatments. Alternative Lifestyle Interventions In Vulnerable Ethnic Groups is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Diabetes Prevention Program (DPP) online + doula divas
BEHAVIORAL
Experimental Group 2
Alternative Lifestyle Interventions in Vulnerable Ethnic groups
BEHAVIORAL
Control Group 3
Diabetes Prevention Program (DPP) online
BEHAVIORAL
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Eligibility

This trial is for female patients aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You are fluent in English. show original
You are post-partum. show original
A clinical diagnosis of GDM is made using the Carpenter Coustan criteria. show original
access to smart phone technology Self identified Black race
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 years post-partum
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years post-partum
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 years post-partum.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Alternative Lifestyle Interventions in Vulnerable Ethnic groups will improve 1 primary outcome and 1 secondary outcome in patients with Hypertension. Measurement will happen over the course of Between 6 to 12 weeks post-partum.

Participants with gestational diabetes that complete the recommended screening for Type 2 Diabetes Mellitus (T2DM)
BETWEEN 6 TO 12 WEEKS POST-PARTUM
Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test
BETWEEN 6 TO 12 WEEKS POST-PARTUM
Participants with gestational diabetes who develop T2DM
2 YEARS POST-PARTUM
Participants diagnosed with Gestational Diabetes receive the T2DM screening is a 75 gram 2-hour glucose tolerance test
2 YEARS POST-PARTUM

Who is running the study

Principal Investigator
R. L.
Prof. Rolanda Lister, Assistant Professor, Obstetrics and Gynecology
Vanderbilt University Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get hypertension a year in the United States?

An estimated 9.9 million Americans have hypertension and another 9.4 million have high blood pressure but are unaware of it. More specifically, there are 1.9 million with hypertension and hypertension-related heart disease.

Anonymous Patient Answer

What causes hypertension?

A number of risk factors have been established, and it is difficult to predict what will come individually and for a family or cluster of families. The best thing to do to help prevent hypertension is to try to reduce the number of risk factors.

Anonymous Patient Answer

What are the signs of hypertension?

In hypertensive patients, arterial blood pressure should routinely be measured, since some patients feel dyspnea when blood pressure is >130/80 mm Hg, while others are asymptomatic. At a blood pressure of >130 mm Hg, it is extremely probable that at that point the atherosclerosis is already severely advanced; the patient therefore should be referred for coronary angiography to detect coronary artery disease (CAD). Also, the presence of heart failure or neurological signs warrants referral to a cardiologist to determine the necessity for immediate revascularization of the coronary arteries. In the present era of cardiology, angiography remains the gold standard for investigating CAD.

Anonymous Patient Answer

Can hypertension be cured?

The majority of patients who are able to stop their medication feel as if they cured their hypertension, despite evidence of a low-normal blood pressure. Some patients, however, were able to achieve and keep a low-normal blood pressure without medications. There is a discrepancy in these patients' perceptions of their treatment, with many of them believing they have cured their hypertension.

Anonymous Patient Answer

What is hypertension?

Hypertension (high blood pressure) causes the buildup of plaque in aorta and can lead to heart valve disease, diabetes, and stroke. Chronic hypertension can lead to heart attack and can increase the risk of stroke, with or without hemorrhage.

Anonymous Patient Answer

What are common treatments for hypertension?

There is an abundant evidence of the therapeutic effectiveness of lifestyle modification and behavioural programs for patients with hypertension. The use of antihypertensive medications such as thiazide diuretics and beta blockers is recommended especially in hypertensive patients over 60 years.

Anonymous Patient Answer

Have there been any new discoveries for treating hypertension?

In summary, the majority of the drugs used to treat hypertension are not used for hypertensive diseases related to the heart and the kidneys. The current medications and therapies are still not effective and continue to be an area of scientific and medical interest. This is demonstrated by the number of medications used, the different types of side effects, and by the lack of more randomized, placebo-controlled, and/or large clinical studies. Nonetheless, some promising therapies have been found to be more effective for treating hypertension than conventional medication. Further, it may prove to be beneficial to take a holistic approach to the management of hypertension and consider all aspects of the patient's wellbeing and lifestyle.

Anonymous Patient Answer

Is alternative lifestyle interventions in vulnerable ethnic groups typically used in combination with any other treatments?

The majority of patients who are treated with an alternative lifestyle intervention in combination with traditional treatments do not receive any other treatment in addition to standard therapy.

Anonymous Patient Answer

What is alternative lifestyle interventions in vulnerable ethnic groups?

Despite the lack of clinical evidence to support their usage, ALI continued to be applied to a wide population across all ethnic groups in the study community. The reasons for its increased use in these populations remain unclear, however. Clearly, intervention strategies that promote good adherence and compliance to lifestyle recommendations are required if effective interventions are to be developed.

Anonymous Patient Answer

What is the average age someone gets hypertension?

It is not clear now whether the age at which hypertension is diagnosed is increasing or whether the importance of timely diagnosis is being neglected. However, the mean age of diagnosis in women is lower than in men. Men tend to get hypertension at a later age.

Anonymous Patient Answer

Have there been other clinical trials involving alternative lifestyle interventions in vulnerable ethnic groups?

There is no evidence that any alternative lifestyle intervention have been studied systematically in ethnic minorities. In order to test for evidence of efficacy it would be necessary to perform large, systematic investigations into the lifestyle, health and social interventions of this particular ethnically targeted population. These would be a daunting task and there is no obvious candidate for the 'lead' role in such trials.

Anonymous Patient Answer

Who should consider clinical trials for hypertension?

Clinicians and their patients are currently the prime targets for enrollment in clinical trials as well as consumers of health care services for hypertension. However, given concerns about low health literacy, the availability of a simplified, portable version of the ECHI-R as a tool to enhance screening for hypertension, and research addressing how to enhance and improve provider-patient communication in order to increase the number of patients who participate in trials and reap the benefits of these trials, are potential enhancements that might increase the number of patients willing and eligible to participate in clinical trials for hypertension. ClinicalTrials.gov (U.S. National Library of Medicine, National Institutes of Health): NCT00918990.

Anonymous Patient Answer
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