Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00094263 |
| Other study ID # |
1273 |
| Secondary ID |
R21HL075259 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 15, 2004 |
| Last updated |
February 17, 2016 |
| Start date |
September 2004 |
| Est. completion date |
July 2007 |
Study information
| Verified date |
January 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To use existing longitudinal data from the Chicago Heart Association and Western Electric
Company studies to examine adiposity in relation to heart failure, multimorbidity and to
examine heart rate in relation to incident diabetes.
Description:
BACKGROUND:
Obesity is reaching epidemic proportions in the U.S. with over 50 percent of the adult
population either overweight or obese. Obesity has been studied extensively as a risk factor
for coronary heart disease and stroke, but has received less attention as a risk factor for
congestive heart failure (CHF). Another area of limited investigation is the study of risk
factors for multi morbidity, i.e. the occurrence of several morbid events at the same time,
which is very common in older adults. Other areas of investigation in this study are
possible associations between each of heart rate and dietary patterns with the development
of diabetes. The Chicago Heart Association Detection Project and the Western Electric
studies, both supported by the National Heart, Lung, and Blood Institute, are resources to
study the above associations. Multiple measures of obesity are available at several
different time points and follow-up data are available for 30-40 years which should increase
the power of the study.
Data to be used for this project include baseline data collected in 1967-73 from 39,522
subjects from the Chicago Heart Association Study (CHA) and baseline and annual follow-up
data from the Western Electric Study collected from 1957-1966 consisting of 2107 men, age
40-55 years in the Chicago area. Mortality follow-up for those 2 cohorts is accomplished via
the National Death Index. Morbidity follow-up is accomplished by record linkage with
Medicare files and to some extent by followup questionnaires for disease outcomes although
the follow-up rate for the latter approach is only about 60 percent.
DESIGN NARRATIVE:
The study uses extensive existing data from the Chicago Heart Association (CHA) [20,854 men
and 16,049 women aged 18-64 at baseline (1967-73)] and Western Electric (WE) [2,107 men aged
40- 55 at baseline (1957-58)] that include four comprehensive sources of outcomes: 1)
mortality data from long-term follow-up; 2) morbidity and other data from Medicare claims
for 19 years from 1984 to 2000; 3) multiple health questionnaires (CHA); and 4) repeated
measures of adiposity from 8 annual re-examinations after baseline (WE). The study addresses
the following specific aims: 1) to investigate in-depth the longitudinal associations of
adiposity as assessed by several indices (body mass index, weight gain, subscapular and
triceps skinfolds, and derived percent body fat) during young adulthood and middle age with
mortality and morbidity from congestive heart failure later in life; 2) to delineate the
relationships of adiposity assessed earlier in life with older-age multimorbidity, the
coexistence of multiple pathological conditions of varying severity -- a very common but
under-studied phenomenon among older adults; 3) to examine in-depth the associations of
heart rate and changes in heart rate with incident diabetes, stratified by obesity status at
baseline. As an exploratory aim, the study will assess whether a) higher fruit and vegetable
and lower sugar intake; and b) higher dairy and calcium intake are associated with lower
adiposity, smaller weight gain, and lower incidence of diabetes.
