An observational study in Cardiovascular Disease, Heart Disease and Stroke, sponsored by Brooklyn College of the City University of New York. Completed. Open to female participants aged 55 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.
Sponsored by Brooklyn College of the City University of New York · Observational
The investigators will conduct an epidemiological analysis of data from the Women's Health Initiative to investigate the prospective association between chocolate intake and the risk of heart disease and stroke.
BACKGROUND: Three recent meta-analyses found significant prospective inverse associations between chocolate intake and cardiovascular disease risk. Evidence from these meta-analyses suggests that such inverse associations may only apply to elderly individuals or those with preexisting major chronic disease.
OBJECTIVE: The investigators will assess the association between habitual chocolate intake and subsequent incident coronary heart disease (CHD) and stroke, and the potential effect of modification by age.
DESIGN: The investigators will conduct multivariable Cox regression analyses using data from 83,310 postmenopausal women free of baseline preexisting major chronic disease in the prospective Women's Health Initiative cohort. Chocolate intake was assessed using a food frequency questionnaire. Physician adjudicated events or deaths were ascertained up to September 30, 2013.
community residents
Exclusion Criteria:
women who ate 1 oz. (28.35 g) of chocolate \<1 time/month
Behavioral: chocolate consumption level
women who ate 1 oz. (28.35 g) of chocolate between 1 and \<1.5 times/month
Behavioral: chocolate consumption level
women who ate 1 oz. (28.35 g) of chocolate between 1.5 and \<3.5 times/month,
Behavioral: chocolate consumption level
women who ate 1 oz. (28.35 g) of chocolate between 3.5 times/month and \<3 times/week
Behavioral: chocolate consumption level
women who ate 1 oz. (28.35 g) of chocolate \>3 times/week
Behavioral: chocolate consumption level
No incidence of serious chronic disease prior to visit 3
Other: physician diagnosis of first occurrence of serious chronic disease
Incidence of serious chronic disease prior to visit 3
Other: physician diagnosis of first occurrence of serious chronic disease
Age\<65 years at follow-up baseline
Behavioral: chocolate consumption level
Age\>=65 years at follow-up baseline
Behavioral: chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
incidence of heart disease
physician adjudicated first occurrence of, or death due to, heart disease
Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
incidence of stroke
physician adjudicated first occurrence of, or death due to, stroke
Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
incidence of heart disease or stroke
physician adjudicated first occurrence of, or death due to, heart disease or stroke
Time frame: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years
change in chocolate intake
change in chocolate intake between visit 1 and 3
Time frame: time between the baseline and visit 3, average 3 years
change in dietary energy intake
change in dietary energy intake between visit 1 and 3
Time frame: time between the baseline and year 3, average 3 years
change in dietary fat intake
change in dietary fat intake between visit 1 and 3
Time frame: time between the baseline and year 3, average 3 years
change in BMI
change in BMI between visit 1 and 3
Time frame: time between the baseline and year 3, average 3 years
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Brooklyn College of the City University of New York