Cardiovascular DiseasesPhase 3HHERNCT00860444
Cardiovascular Risk Reduction Program Aimed at African American Women (The HHER Lifestyle Program)
A Phase 3 study testing Basic Educational and Counseling Program and Comprehensive Educational and Counseling Program in people with Cardiovascular Diseases, run by The University of Texas Health Science Center at San Antonio.
Trial summary
Cardiovascular disease (CVD) is a serious health problem among African American women. This study will evaluate a health care center-based program that aims to encourage African American women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing CVD. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Basic Educational and Counseling Program and Comprehensive Educational and Counseling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Apr 2008
- Phase
- Phase 3
- 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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American women
- Able and willing to complete survey instruments and assessment procedures
Who cannot join
- Physical disability or orthopedic problem that limits physical activity
- Elevated blood pressure (i.e., greater than 160/95 mm Hg)
- Insulin-dependent diabetes
- Pregnant or planning to become pregnant during the study period
About this study
Official title: The Heart Healthy and Ethnically Relevant (HHER) Lifestyle Program for Cardiovascular Risk Reduction
Cardiovascular disease (CVD) is a serious health problem among African American women. This study will evaluate a health care center-based program that aims to encourage African American women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing CVD.
Read the detailed description
CVD is the leading cause of death for women in the United States. It affects African American women at a higher rate than it does white women. People at risk for CVD are encouraged to maintain a healthy weight, eat a healthy diet that is low in fat and cholesterol, and increase their physical activity. Heath care centers are excellent places to provide counseling to people on ways to reduce their risk of CVD. In this study, researchers will evaluate the effectiveness of a community health care center-based counseling program aimed at reducing CVD risk factors among African American women from financially disadvantaged backgrounds.
This study will enroll African American women. Participants will be randomly assigned to one of two groups-either a basic program or a comprehensive program. During a routine, scheduled visit with their health care providers, all participants will learn about the importance of increasing physical activity and eating a low fat diet. All participants will also receive educational materials and a community resource guide. In addition to this, participants in the comprehensive program will receive a pedometer and will be asked to keep a daily log of their physical activity and eating habits. Once a month, these same participants will receive telephone calls from a health counselor and a newsletter by mail that encourages them to maintain a healthy lifestyle. All participants will receive home visits from study staff at baseline and Months 6 and 12. During these visits, participants will undergo blood pressure, weight, height, and waist measurements and a blood collection. Participants will complete questionnaires to assess their medical history, diet, and physical activity habits. For 1 week after each visit, participants will wear a physical activity monitor and keep an activity diary.
- Conditions
- Cardiovascular Diseases
- Being tested
- Basic Educational and Counseling Program, Comprehensive Educational and Counseling Program
- Keywords
- Primary Care, Diet, Physical Activity
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basic Educational and Counseling ProgramBehavioural
Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.
Comprehensive Educational and Counseling ProgramBehavioural
Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting. They will also receive 12 months of telephone counseling and a monthly newsletter.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants will take part in the basic educational and counseling program through their community health care center. Receives: Behavioral: Basic Educational and Counseling Program |
| 2 | Experimental | Participants will take part in the comprehensive educational and counseling program through their community health care center. Receives: Behavioral: Comprehensive Educational and Counseling Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours per week in moderate and vigorous intensity physical activities (MVPA), as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire
Measured: Measured at baseline and Months 6 and 12
Weekly consumption frequency of dietary fat and cholesterol, as measured by the New Leaf Dietary Risk Assessment (DRA)
Measured: Measured at baseline and Months 6 and 12
Secondary outcomes (3)
Body mass index (weight [kg]/height [m2])
Measured: Measured at baseline and Months 6 and 12
Central adiposity (i.e., waist circumference in inches)
Measured: Measured at baseline and Months 6 and 12
Total cholesterol (mg/dL)
Measured: Measured at baseline and Months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Deborah Parra-Medina, The University of Texas Health Science Center at San Antonio
- Investigators
- Deborah Parra-Medina, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860444
- Sponsor's protocol ID
- 622
- Other IDs
- R01HL073001
- Acronym
- HHER
- Status last verified
- Jan 2014
- First submitted
- 10 Mar 2009
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parra-Medina D, Wilcox S, Wilson DK, Addy CL, Felton G, Poston MB. Heart Healthy and Ethnically Relevant (HHER) Lifestyle trial for improving diet and physical activity in underserved African American women. Contemp Clin Trials. 2010 Jan;31(1):92-104. doi: 10.1016/j.cct.2009.09.006. Epub 2009 Sep 22.
PubMed 19781665Parra-Medina D, Wilcox S, Salinas J, Addy C, Fore E, Poston M, Wilson DK. Results of the Heart Healthy and Ethnically Relevant Lifestyle trial: a cardiovascular risk reduction intervention for African American women attending community health centers. Am J Public Health. 2011 Oct;101(10):1914-21. doi: 10.2105/AJPH.2011.300151. Epub 2011 Aug 18.
PubMed 21852629Wilcox S, Parra-Medina D, Felton GM, Poston MB, McClain A. Adoption and implementation of physical activity and dietary counseling by community health center providers and nurses. J Phys Act Health. 2010 Sep;7(5):602-12. doi: 10.1123/jpah.7.5.602.
PubMed 20864755
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heart Healthy and Ethnically Relevant (HHER) Lifestyle Program for Cardiovascular Risk Reduction
- ClinicalTrials.gov ID
- NCT00860444
- Acronym / sponsor ID
- HHER / 622
- Conditions
- Cardiovascular Diseases
- Keywords
- Primary Care, Diet, Physical Activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Mar 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.
Cardiovascular disease (CVD) is a serious health problem among African American women. This study will evaluate a health care center-based program that aims to encourage African American women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing CVD.
Detailed description
CVD is the leading cause of death for women in the United States. It affects African American women at a higher rate than it does white women. People at risk for CVD are encouraged to maintain a healthy weight, eat a healthy diet that is low in fat and cholesterol, and increase their physical activity. Heath care centers are excellent places to provide counseling to people on ways to reduce their risk of CVD. In this study, researchers will evaluate the effectiveness of a community health care center-based counseling program aimed at reducing CVD risk factors among African American women from financially disadvantaged backgrounds.
This study will enroll African American women. Participants will be randomly assigned to one of two groups-either a basic program or a comprehensive program. During a routine, scheduled visit with their health care providers, all participants will learn about the importance of increasing physical activity and eating a low fat diet. All participants will also receive educational materials and a community resource guide. In addition to this, participants in the comprehensive program will receive a pedometer and will be asked to keep a daily log of their physical activity and eating habits. Once a month, these same participants will receive telephone calls from a health counselor and a newsletter by mail that encourages them to maintain a healthy lifestyle. All participants will receive home visits from study staff at baseline and Months 6 and 12. During these visits, participants will undergo blood pressure, weight, height, and waist measurements and a blood collection. Participants will complete questionnaires to assess their medical history, diet, and physical activity habits. For 1 week after each visit, participants will wear a physical activity monitor and keep an activity diary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Basic Educational and Counseling ProgramParticipants will take part in the basic educational and counseling program through their community health care center. |
| 2 | Experimental | Behavioral: Comprehensive Educational and Counseling ProgramParticipants will take part in the comprehensive educational and counseling program through their community health care center. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American women
- Able and willing to complete survey instruments and assessment procedures
Key exclusion criteria (4 listed)
- Physical disability or orthopedic problem that limits physical activity
- Elevated blood pressure (i.e., greater than 160/95 mm Hg)
- Insulin-dependent diabetes
- Pregnant or planning to become pregnant during the study period
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 |
|---|---|---|
| Basic Educational and Counseling ProgramParticipants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting. | Behavioural | 1 |
| Comprehensive Educational and Counseling ProgramParticipants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting. They will also receive 12 months of telephone counseling and a monthly newsletter. | Behavioural | 2 |
Primary outcome
Hours per week in moderate and vigorous intensity physical activities (MVPA), as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire
Time frame: Measured at baseline and Months 6 and 12
Weekly consumption frequency of dietary fat and cholesterol, as measured by the New Leaf Dietary Risk Assessment (DRA)
Time frame: Measured at baseline and Months 6 and 12
3 secondary outcomes
Body mass index (weight [kg]/height [m2])
Time frame: Measured at baseline and Months 6 and 12
Central adiposity (i.e., waist circumference in inches)
Time frame: Measured at baseline and Months 6 and 12
Total cholesterol (mg/dL)
Time frame: Measured at baseline and Months 6 and 12
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 7 Jan 2014.
- Background: PubMed 19781665Parra-Medina D, Wilcox S, Wilson DK, Addy CL, Felton G, Poston MB. Heart Healthy and Ethnically Relevant (HHER) Lifestyle trial for improving diet and physical activity in underserved African American women. Contemp Clin Trials. 2010 Jan;31(1):92-104. doi: 10.1016/j.cct.2009.09.006. Epub 2009 Sep 22.
- Results publication: PubMed 21852629Parra-Medina D, Wilcox S, Salinas J, Addy C, Fore E, Poston M, Wilson DK. Results of the Heart Healthy and Ethnically Relevant Lifestyle trial: a cardiovascular risk reduction intervention for African American women attending community health centers. Am J Public Health. 2011 Oct;101(10):1914-21. doi: 10.2105/AJPH.2011.300151. Epub 2011 Aug 18.
- Results publication: PubMed 20864755Wilcox S, Parra-Medina D, Felton GM, Poston MB, McClain A. Adoption and implementation of physical activity and dietary counseling by community health center providers and nurses. J Phys Act Health. 2010 Sep;7(5):602-12. doi: 10.1123/jpah.7.5.602.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Deborah Parra-Medina, PhD principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Basic Educational and Counseling Program and Comprehensive Educational and Counseling Program in people with Cardiovascular Diseases, run by The University of Texas Health Science Center at San Antonio.
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 2 inclusion and 4 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hours per week in moderate and vigorous intensity physical activities (MVPA), as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire (time frame: Measured at baseline and Months 6 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860444, which also lists 3 linked publications.
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 7 Jan 2014.