Study of Hispanics to Assess Risk Prevention in Prehypertension (SHARPP)
This study has been terminated.
(The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.)
Sponsor:
Florida Heart Research Institute
Information provided by (Responsible Party):
Maria Canossa Terris MD, Florida Heart Research Institute
ClinicalTrials.gov Identifier:
NCT01025323
First received: December 2, 2009
Last updated: March 12, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.
| Condition | Intervention |
|---|---|
|
Pre-Hypertension |
Behavioral: Lifestyle modification |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Lifestyle Intervention in Multinational Hispanics With Prehypertension |
Resource links provided by NLM:
Further study details as provided by Florida Heart Research Institute:
Primary Outcome Measures:
- To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 58 |
| Study Start Date: | December 2007 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Minimal Intervention Group
Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction.
|
Behavioral: Lifestyle modification
DASH diet and exercise advice
Other Name: MIG
|
|
Active Comparator: Enhanced Intervention Group
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.
|
Behavioral: Lifestyle modification
DASH diet, exercise with systematic instruction by a dietician and/or coordinator
Other Name: EIG
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025323
Locations
| United States, Florida | |
| Florida Heart Research Institute | |
| Miami, Florida, United States, 33137 | |
Sponsors and Collaborators
Florida Heart Research Institute
Investigators
| Principal Investigator: | Maria Canossa-Terris, MD | Florida Heart Research Institute |
More Information
No publications provided
| Responsible Party: | Maria Canossa Terris MD, Medical Director, Florida Heart Research Institute |
| ClinicalTrials.gov Identifier: | NCT01025323 History of Changes |
| Other Study ID Numbers: | FHRI 2007-02 |
| Study First Received: | December 2, 2009 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Florida Heart Research Institute:
|
Pre hypertension Lifestyle modification DASH diet |
Additional relevant MeSH terms:
|
Hypertension Prehypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013