Pre-HypertensionSHARPPNCT01025323
Study of Hispanics to Assess Risk Prevention in Prehypertension
A study testing Lifestyle modification in people with Pre-Hypertension, run by Florida Heart Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pre-Hypertension
- What is being tested?
- Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Mar 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hispanic men and women age 18 or older
- Mean baseline SBP 130-139 mmHg and DBP 85-89 mmHg on screening visits 1\&2
- Subjects who have access to a telephone
- Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study
- Subjects who are willing and capable of complying with the requirements of the study
Who cannot join
- BMI > 35
- Pregnant or breast feeding
- Currently taking any anti-hypertensive medications
- History of cardiovascular disease (Stroke, MI, PCI, CABG)
- Current symptoms of angina or peripheral vascular disease by Rose questionnaire
- Fasting glucose ≥ 126mg/dl) or a history of diabetes and use of antidiabetic medication
Show all 16Show fewer
- Use of oral corticosteroids > 5days/month on average
- Consumption of more than 21 alcoholic drinks per week or consumption of 6 or more drinks on one occasion twice or more per week in the past 3 months prior to screening visit
- Use of weight loss medications (prescription or over the counter) in the past 3 months prior to screening visit 1 or body weight change > 15 pounds in the 3 months prior to screening visit
- Currently undergoing or planning to undergo treatment for a neoplastic disease
- Clinical significant laboratory test results that are indicative of a serious medical condition
- Renal Insufficiency (GFR<60ml/min as estimated using Cockcroft -Gault formula)
- Any orthopedic or rheumatologic problems that might limit a subject's ability to participate in the physical activity component of the intervention
- Any medical condition which in the judgment of the Investigator places the subject at risk due to his/her participation in the study, is likely to prevent the subject from complying with the requirements of the study or completing the study or which may jeopardize the evaluation of efficacy or safety
- Planning to leave area prior to the anticipated end of participation
- Current participation in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Heart Research Institute
Miami, Florida, 33137
About this study
Official title: Lifestyle Intervention in Multinational Hispanics With Prehypertension
The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.
Read the detailed description
In this study participants (who have prehypertension as defined as systolic blood pressure - the upper number- 130-139 mmHg and diastolic blood pressure 85-89mmHg- the lower number-) are randomly assigned to one of two groups:
the Minimal Intervention Group- participants receive advice and printed guidelines only but no counseling or personalized instruction, or the Enhanced Intervention Group- participants receive advice and the same printed guidelines as the minimal intervention group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and personalized instructions.
- Conditions
- Pre-Hypertension
- Being tested
- Lifestyle modification
- Keywords
- Pre hypertension, Lifestyle modification, DASH diet
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle modificationBehavioural
Also called MIG
DASH diet and exercise advice
Lifestyle modificationBehavioural
Also called EIG
DASH diet, exercise with systematic instruction by a dietician and/or coordinator
| Study group | Role | What they receive |
|---|---|---|
| Minimal Intervention Group | Active comparator | Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction. Receives: Behavioral: Lifestyle modification |
| Enhanced Intervention Group | Active comparator | Participants in this group receive advice and the same printed guidelines as the Minimal Intervention Group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and systematic instruction. Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group
Measured: 6 months
Secondary outcomes (1)
The test the effect on systolic and diastolic blood pressure,lipid profile, glucose level, c-reactive protein and body mass index of the Enhanced Intervention Group in comparison to the Minimal Intervention Group
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startDec 2007
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-HypertensionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Heart Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Canossa Terris MD, Florida Heart Research Institute
- Investigators
- Maria Canossa-Terris, MD, Principal investigator, Florida Heart Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025323
- Sponsor's protocol ID
- FHRI 2007-02
- Acronym
- SHARPP
- Status last verified
- Mar 2013
- First submitted
- 2 Dec 2009
- Last updated
- 13 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention in Multinational Hispanics With Prehypertension
- ClinicalTrials.gov ID
- NCT01025323
- Acronym / sponsor ID
- SHARPP / FHRI 2007-02
- Conditions
- Pre-Hypertension
- Keywords
- Pre hypertension, Lifestyle modification, DASH diet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Florida Heart Research InstituteUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Dec 2009 (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 this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.
Detailed description
In this study participants (who have prehypertension as defined as systolic blood pressure - the upper number- 130-139 mmHg and diastolic blood pressure 85-89mmHg- the lower number-) are randomly assigned to one of two groups:
the Minimal Intervention Group- participants receive advice and printed guidelines only but no counseling or personalized instruction, or the Enhanced Intervention Group- participants receive advice and the same printed guidelines as the minimal intervention group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and personalized instructions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Intervention Group | Active comparator | Behavioral: Lifestyle modificationParticipants in this arm receive advice and printed guidelines but no counseling or systematic instruction. |
| Enhanced Intervention Group | Active comparator | Behavioral: Lifestyle modificationParticipants in this group receive advice and the same printed guidelines as the Minimal Intervention Group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and systematic instruction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hispanic men and women age 18 or older
- Mean baseline SBP 130-139 mmHg and DBP 85-89 mmHg on screening visits 1\&2
- Subjects who have access to a telephone
- Subjects who have read, signed and received a copy of the informed consent form prior to the initiation of any study procedures and who agree to participate in all aspects of the study
- Subjects who are willing and capable of complying with the requirements of the study
Key exclusion criteria (16 listed)
- BMI > 35
- Pregnant or breast feeding
- Currently taking any anti-hypertensive medications
- History of cardiovascular disease (Stroke, MI, PCI, CABG)
- Current symptoms of angina or peripheral vascular disease by Rose questionnaire
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 |
|---|---|---|
| Lifestyle modificationAlso: MIGDASH diet and exercise advice | Behavioural | Minimal Intervention Group |
| Lifestyle modificationAlso: EIGDASH diet, exercise with systematic instruction by a dietician and/or coordinator | Behavioural | Enhanced Intervention Group |
Primary outcome
To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group
Time frame: 6 months
1 secondary outcome
The test the effect on systolic and diastolic blood pressure,lipid profile, glucose level, c-reactive protein and body mass index of the Enhanced Intervention Group in comparison to the Minimal Intervention Group
Time frame: 6, 12 and 18 months
Results and safety
The study was stopped early (reason given: The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
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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.
Maria Canossa-Terris, MD principal investigator
Florida Heart Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle modification in people with Pre-Hypertension, run by Florida Heart Research Institute 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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 13 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 was stopped early (reason given: The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.). Results are not available in the source record.
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?
To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group (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 13 Mar 2013.