Cardiovascular DiseasesNCT00005478
Precursors of CVD Risk Factors--Project Heartbeat
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To elucidate the changes in body size, composition, and configuration occurring in adolescence, because these are important precursors of change in blood pressure and blood lipids. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1996to Sep 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 8 to 14 years
- All sexes
- No healthy volunteers
- Child
No eligibility criteria
About this study
To elucidate the changes in body size, composition, and configuration occurring in adolescence, because these are important precursors of change in blood pressure and blood lipids.
Read the detailed description
BACKGROUND:
Project HeartBeat! was uniquely designed to investigate the course of change in cardiovascular disease risk factors and several categories of covariates, including the anthropometric indicators addressed in this study. The data pertained to the 678 participants who entered the Project in 1991-93 at ages 8, 11 or 14 years of age, of whom 49.1 percent were female and 20.1 percent were black. Of the 395 participants who became eligible for 10 or more 4-monthly examinations, 349 (88.4 percent) completed at least 10 occasions; 538 participants of 556 who were eligible for seven or more examinations (96.8 percent) completed at least seven. Multi-level (MLn) analytic methods previously tested with other data were utilized for this analysis.
DESIGN NARRATIVE:
Data from Project Heartbeat were analyzed. Hypotheses tested included: (1) the time patterns of change in several indicators of body size, composition and configuration over the period of observation; (2) the relations between the time patterns of change in these indicators and the corresponding patterns for change in selected endocrine factors; and (3) the explanatory contributions of energy intake and expenditure to variation between individuals in their observed time patterns of change in these indicators. The anthropometric indicators addressed were: weight (total mass), height, body mass index (BMI, wt/ht2), fat-free mass, fat mass, per cent body fat, and fat distribution (waist/hip ratio). Each of these indicators were examined first separately and then in relation to selected endocrinologic measures (testosterone, estradiol, and DHEAS) and to energy intake and expenditure (from interview histories of diet and physical activity). Existing data from up to twelve 4-monthly examinations over the age range from 8-17 years conducted in Project HeartBeat! were analyzed.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hypertension
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 startSep 1996
- Study completionSep 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- US National Institutes of Health
- Investigators
- Darwin Labarthe, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005478
- Sponsor's protocol ID
- 4962
- Other IDs
- R03HL057101
- Status last verified
- Mar 2004
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precursors of CVD Risk Factors--Project Heartbeat
- ClinicalTrials.gov ID
- NCT00005478
- Acronym / sponsor ID
- 4962
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Sep 1998 (actual)
- 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 elucidate the changes in body size, composition, and configuration occurring in adolescence, because these are important precursors of change in blood pressure and blood lipids.
Detailed description
BACKGROUND:
Project HeartBeat! was uniquely designed to investigate the course of change in cardiovascular disease risk factors and several categories of covariates, including the anthropometric indicators addressed in this study. The data pertained to the 678 participants who entered the Project in 1991-93 at ages 8, 11 or 14 years of age, of whom 49.1 percent were female and 20.1 percent were black. Of the 395 participants who became eligible for 10 or more 4-monthly examinations, 349 (88.4 percent) completed at least 10 occasions; 538 participants of 556 who were eligible for seven or more examinations (96.8 percent) completed at least seven. Multi-level (MLn) analytic methods previously tested with other data were utilized for this analysis.
DESIGN NARRATIVE:
Data from Project Heartbeat were analyzed. Hypotheses tested included: (1) the time patterns of change in several indicators of body size, composition and configuration over the period of observation; (2) the relations between the time patterns of change in these indicators and the corresponding patterns for change in selected endocrine factors; and (3) the explanatory contributions of energy intake and expenditure to variation between individuals in their observed time patterns of change in these indicators. The anthropometric indicators addressed were: weight (total mass), height, body mass index (BMI, wt/ht2), fat-free mass, fat mass, per cent body fat, and fat distribution (waist/hip ratio). Each of these indicators were examined first separately and then in relation to selected endocrinologic measures (testosterone, estradiol, and DHEAS) and to energy intake and expenditure (from interview histories of diet and physical activity). Existing data from up to twelve 4-monthly examinations over the age range from 8-17 years conducted in Project HeartBeat! were analyzed.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- 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 13 May 2016.
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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.
Darwin Labarthe
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 13 May 2016. 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?
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 May 2016.