Cardiovascular DiseasesNCT00005437
Physical Activity and Cardiovascular Risk in Black Girls
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center, Houston.
Trial summary
To conduct a longitudinal study investigating the physical activity patterns, the psychosocial predictors of physical activity, and the effects of physical activity changes on blood pressure and body fatness in a cohort of African-American girls, ages 11-17. Read more about this study
- Who is it for?
- Ages 11 to 17 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 1992to Jan 1998
- Phase
- Observational
- 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 11 to 17 years
- Women only
- No healthy volunteers
- Child
No eligibility criteria
About this study
To conduct a longitudinal study investigating the physical activity patterns, the psychosocial predictors of physical activity, and the effects of physical activity changes on blood pressure and body fatness in a cohort of African-American girls, ages 11-17.
Read the detailed description
BACKGROUND:
The study contributed to an underdeveloped area of research. Physical activity is recommended as a nonpharmacological means to modify hypertension and obesity, two cardiovascular risk factors. African-American women have low levels of physical activity and high rates of obesity, hypertension, and mortality from coronary heart disease, diabetes, and hypertensive diseases. In 1992, there was an absence of longitudinal data about the physical activity habits of African-American girls even though a decline in physical activity during adolescence had been reported in other subpopulations.
DESIGN NARRATIVE:
Within the framework of puberty and maturation, the study: 1) described longitudinal patterns of physical activity; 2) assessed longitudinal changes in physical activity and concomitant changes in blood pressure and body fatness; and 3) determined psychosocial predictors of changes in physical activity. The investigators hypothesized that there would be a monotonic decrease in physical activity and that psychosocial variables would predict changes in physical activity. The study population consisted of 189 sixth grade, mostly African-American, girls in Fort Bend Independent School District, Missouri City, Texas. The girls were measured for four and a half years, ages 11 or 12 at entry of the study. Anthropometry, sexual maturation, blood pressure, physical activity habits and psychosocial predictors were measured twice a year for a total of nine examinations. Data on dietary, smoking and drinking habits were collected annually. Activity patterns, psychosocial predictors and other habits were assessed by interviews and questionnaires. Sexual maturation was assessed by menarche and the Tanner stages. Skinfold and circumference measures determined body fatness and body fat distribution.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startFeb 1992
- Study completionJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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, HoustonThe 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
- Observational
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Wedell Taylor, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005437
- Sponsor's protocol ID
- 4365
- Other IDs
- R29HL047659
- Status last verified
- Sep 2021
- First submitted
- 25 May 2000
- Last updated
- 1 Oct 2021
- Results posted
- No
Publications
Taylor WC, Yancey AK, Leslie J, Murray NG, Cummings SS, Sharkey SA, Wert C, James J, Miles O, McCarthy WJ. Physical activity among African American and Latino middle school girls: consistent beliefs, expectations, and experiences across two sites. Women Health. 1999;30(2):67-82. doi: 10.1300/j013v30n02_05.
PubMed 10881759Taylor WC, Chan W, Cummings SS, Simons-Morton BG, Day RS, Sangi-Haghpeykar H, Pivarnik JS, Mueller WH, Detry MA, Wei II, Johnson-Masotti AP, Hsu HA. Healthy Growth: project description and baseline findings. Ethn Dis. 2002 Fall;12(4):567-77.
PubMed 12477144
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Cardiovascular Risk in Black Girls
- ClinicalTrials.gov ID
- NCT00005437
- Acronym / sponsor ID
- 4365
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hypertension, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 1992
- Study completion
- Jan 1998
- First posted
- 26 May 2000 (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.
To conduct a longitudinal study investigating the physical activity patterns, the psychosocial predictors of physical activity, and the effects of physical activity changes on blood pressure and body fatness in a cohort of African-American girls, ages 11-17.
Detailed description
BACKGROUND:
The study contributed to an underdeveloped area of research. Physical activity is recommended as a nonpharmacological means to modify hypertension and obesity, two cardiovascular risk factors. African-American women have low levels of physical activity and high rates of obesity, hypertension, and mortality from coronary heart disease, diabetes, and hypertensive diseases. In 1992, there was an absence of longitudinal data about the physical activity habits of African-American girls even though a decline in physical activity during adolescence had been reported in other subpopulations.
DESIGN NARRATIVE:
Within the framework of puberty and maturation, the study: 1) described longitudinal patterns of physical activity; 2) assessed longitudinal changes in physical activity and concomitant changes in blood pressure and body fatness; and 3) determined psychosocial predictors of changes in physical activity. The investigators hypothesized that there would be a monotonic decrease in physical activity and that psychosocial variables would predict changes in physical activity. The study population consisted of 189 sixth grade, mostly African-American, girls in Fort Bend Independent School District, Missouri City, Texas. The girls were measured for four and a half years, ages 11 or 12 at entry of the study. Anthropometry, sexual maturation, blood pressure, physical activity habits and psychosocial predictors were measured twice a year for a total of nine examinations. Data on dietary, smoking and drinking habits were collected annually. Activity patterns, psychosocial predictors and other habits were assessed by interviews and questionnaires. Sexual maturation was assessed by menarche and the Tanner stages. Skinfold and circumference measures determined body fatness and body fat distribution.
Study design
Who may qualify
- Ages
- 11 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 1 Oct 2021.
- Background: PubMed 10881759Taylor WC, Yancey AK, Leslie J, Murray NG, Cummings SS, Sharkey SA, Wert C, James J, Miles O, McCarthy WJ. Physical activity among African American and Latino middle school girls: consistent beliefs, expectations, and experiences across two sites. Women Health. 1999;30(2):67-82. doi: 10.1300/j013v30n02_05.
- Background: PubMed 12477144Taylor WC, Chan W, Cummings SS, Simons-Morton BG, Day RS, Sangi-Haghpeykar H, Pivarnik JS, Mueller WH, Detry MA, Wei II, Johnson-Masotti AP, Hsu HA. Healthy Growth: project description and baseline findings. Ethn Dis. 2002 Fall;12(4):567-77.
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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.
Wedell Taylor
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Oct 2021. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005437, which also lists 2 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 1 Oct 2021.