Cardiovascular Disease, Heart Disease, Stroke
Conditions
Keywords
Coronary heart disease, stroke, chocolate consumption, postmenopausal women, nutrition, dietary intake, epidemiology
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALchocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
OTHERphysician diagnosis of first occurrence of serious chronic disease
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Department of Health and Human Services
Brooklyn College of the City University of New York
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
1. Postmenopausal women 2. age between 50 and 79 years 3. enrolled in the Women's Health Initiative (WHI) Observational Study, or in the control arm of one or more overlapping WHI clinical trials.
Exclusion criteria
1. implausible energy intakes, defined as \<600 kcal/d or \>5,000 kcal/d; 2. implausible body mass indices (BMI) (\<15 or \>50 kg/m2) 3. implausible height\<122 cm (4 ft.) 4. self-reported preexisting serious chronic disease at baseline, including diabetes, angina, myocardial infarction (MI), stroke, heart failure, coronary artery bypass graft, percutaneous coronary intervention or cancer. 5. missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of heart disease | between the baseline survey (1993-8) & September 30, 2013, average 13.4 years | physician adjudicated first occurrence of, or death due to, heart disease |
| incidence of stroke | between the baseline survey (1993-8) & September 30, 2013, average 13.4 years | physician adjudicated first occurrence of, or death due to, stroke |
| incidence of heart disease or stroke | between the baseline survey (1993-8) & September 30, 2013, average 13.4 years | physician adjudicated first occurrence of, or death due to, heart disease or stroke |
| change in chocolate intake | time between the baseline and visit 3, average 3 years | change in chocolate intake between visit 1 and 3 |
| change in dietary energy intake | time between the baseline and year 3, average 3 years | change in dietary energy intake between visit 1 and 3 |
| change in dietary fat intake | time between the baseline and year 3, average 3 years | change in dietary fat intake between visit 1 and 3 |
| change in BMI | time between the baseline and year 3, average 3 years | change in BMI between visit 1 and 3 |
Outcome results
None listed