Precursors of CVD Risk Factors--Project Heartbeat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005478
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : May 13, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief 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.

Condition or disease
Cardiovascular Diseases Heart Diseases Hypercholesterolemia Hypertension

Detailed Description:


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.


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 Type : Observational
Study Start Date : September 1996
Actual Study Completion Date : September 1998

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005478

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Darwin Labarthe University of Texas Identifier: NCT00005478     History of Changes
Other Study ID Numbers: 4962
R03HL057101 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: March 2004

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Lipid Metabolism Disorders
Metabolic Diseases