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ADAPT-Altering Diet for African American Populations to Treat Hypertension

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Hypertension

Treatments

Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet
Behavioral: Intervention with no dietary component - information regarding useful life skills

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00621569
F0408110045
U01HL079171 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of the study is to develop a culturally appropriate DASH intervention and test the effectiveness of the intervention lower blood pressure in a group of African American participants at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).

Full description

The effectiveness of the Dietary Approaches to Stop Hypertension (DASH) diet has shown to have limited impact on blood pressure control among African Americans, which might be explained by inappropriate adaptation to African American culture and tradition. Therefore, the adequate adaptation of the DASH diet would result in blood pressure control among African-Americans. Using the nominal group technique as a part of the formative assessment, this project proposes to identify key cultural variables that impact dietary patterns for African Americans. Based on those results, a modified behavioral intervention will be developed and tested in African Americans with pre-hypertension or stage I hypertension. Primary outcomes will include change in systolic and diastolic blood pressure at six months. It is expected that this project will contribute an additional tool for physicians, patients and health care systems to improve hypertension control amongst African Americans. The specific aims for this dietary intervention are: (1) to develop a modified DASH dietary pattern that is culturally appropriate for African-Americans by using principals of formative analysis and (2) to conduct a randomized, controlled trial to determine the effectiveness of the modified DASH dietary pattern in reducing blood pressure for a cohort of African-Americans with pre-hypertension or stage I hypertension to a usual care control group.

Enrollment

122 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Baseline SBP 120-159 mmHg and DBP 80-95 mmHg
  • Age 25 or older as of the initial screening visit
  • Willing and able to participate fully in all aspects of the intervention
  • Not on rigid diet
  • Provide informed consent
  • BMI 18.5-45 kg/m2

Exclusion criteria

  • Regular use of anti-hypertensive drugs or other drugs that raise or lower BP (any in previous three months)
  • Current use of insulin or oral hypoglycemic agents
  • Use of oral corticosteroids >5 days/month on average
  • Current use of medications for treatment of psychosis or manic-depressive illness
  • Use of oral breathing medications other than inhalers > 5 days/month on average
  • Use of weight-loss medications in previous 3 months

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

122 participants in 2 patient groups

1
Active Comparator group
Description:
Group intervention with no dietary focus
Treatment:
Behavioral: Intervention with no dietary component - information regarding useful life skills
2
Experimental group
Description:
DASH diet intervention
Treatment:
Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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