HypertensionADAPTNCT00621569
ADAPT-Altering Diet for African American Populations to Treat Hypertension
A study testing Dietary Approaches to Stop Hypertension-The DASH diet and Intervention with no dietary component - information regarding useful life skills in people with Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Dietary Approaches to Stop Hypertension-The DASH diet and Intervention with no dietary component - information regarding useful life skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Department of Nutrition Sciences
Birmingham, Alabama, 35294-3360
About this study
Official title: A Culturally Appropriate Intervention in Hypertensive African-Americans Based on the DASH Diet-The ADAPT Hypertension Study = Altering Diet for African American Populations to Treat Hypertension
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).
Read the detailed 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.
- Conditions
- Hypertension
- Being tested
- Dietary Approaches to Stop Hypertension-The DASH diet, Intervention with no dietary component - information regarding useful life skills
- Keywords
- Blood Pressure, Dash Diet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Approaches to Stop Hypertension-The DASH dietBehavioural
The purpose of this study is to create a culturally appropriate diet to test the effectiveness of the intervention to lower blood pressure in a grou pof African American individuals at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I).
Intervention with no dietary component - information regarding useful life skillsBehavioural
Participants receive information regarding useful life skills in a group setting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Group intervention with no dietary focus Receives: Behavioral: Intervention with no dietary component - information regarding useful life skills |
| 2 | Experimental | DASH diet intervention Receives: Behavioral: Dietary Approaches to Stop Hypertension-The DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure with dietary intervention
Measured: 6 months
Secondary outcomes (1)
Change in weight
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2005
- Primary completionJul 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jamy Ard, MD, University of Alabama at Birmingham
- Investigators
- Jamy D Ard, MD, Principal investigator, University of Alabama at BirminghamCatarina Kiefe, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621569
- Sponsor's protocol ID
- F0408110045
- Other IDs
- U01HL079171
- Acronym
- ADAPT
- Status last verified
- Mar 2013
- First submitted
- 12 Feb 2008
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Appropriate Intervention in Hypertensive African-Americans Based on the DASH Diet-The ADAPT Hypertension Study = Altering Diet for African American Populations to Treat Hypertension
- ClinicalTrials.gov ID
- NCT00621569
- Acronym / sponsor ID
- ADAPT / F0408110045
- Conditions
- Hypertension
- Keywords
- Blood Pressure, Dash Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Intervention with no dietary component - information regarding useful life skillsGroup intervention with no dietary focus |
| 2 | Experimental | Behavioral: Dietary Approaches to Stop Hypertension-The DASH dietDASH diet intervention |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Approaches to Stop Hypertension-The DASH dietThe purpose of this study is to create a culturally appropriate diet to test the effectiveness of the intervention to lower blood pressure in a grou pof African American individuals at risk for developing hypertension (pre-hypertension) and those with mild hypertension (stage I). | Behavioural | 2 |
| Intervention with no dietary component - information regarding useful life skillsParticipants receive information regarding useful life skills in a group setting | Behavioural | 1 |
Primary outcome
Change in blood pressure with dietary intervention
Time frame: 6 months
1 secondary outcome
Change in weight
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
- Alabama Collaboration for Cardiovascular Equality (ACCE) is an initiative under the leadership of Drs. Catarina Kiefe and Sandral Hullett and is comprised of STORIES (NCT00101491), led by Dr. Thomas Houston, and ADAPT (NCT00621569), led by Dr. Jamy ArdLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamy D Ard, MD principal investigator
University of Alabama at Birmingham
Catarina Kiefe, MD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Approaches to Stop Hypertension-The DASH diet and Intervention with no dietary component - information regarding useful life skills in people with Hypertension, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure with dietary intervention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.