Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
83310 participants
OBSERVATIONAL
2014-12-15
2018-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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chocolate consumption level referent
women who ate 1 oz. (28.35 g) of chocolate \<1 time/month
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 2
women who ate 1 oz. (28.35 g) of chocolate between 1 and \<1.5 times/month
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 3
women who ate 1 oz. (28.35 g) of chocolate between 1.5 and \<3.5 times/month,
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 4
women who ate 1 oz. (28.35 g) of chocolate between 3.5 times/month and \<3 times/week
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
chocolate consumption level 5
women who ate 1 oz. (28.35 g) of chocolate \>3 times/week
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
No physician diagnosis
No incidence of serious chronic disease prior to visit 3
physician diagnosis of first occurrence of serious chronic disease
Physician diagnosis
Incidence of serious chronic disease prior to visit 3
physician diagnosis of first occurrence of serious chronic disease
Younger
Age\<65 years at follow-up baseline
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
Older
Age\>=65 years at follow-up baseline
chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
Interventions
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chocolate consumption level
level of consumption of 1 oz. of chocolate, as assessed at baseline
physician diagnosis of first occurrence of serious chronic disease
Eligibility Criteria
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Inclusion Criteria
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
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.
55 Years
79 Years
FEMALE
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Department of Health and Human Services
FED
Brooklyn College of the City University of New York
OTHER
Responsible Party
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James Greenberg
Associate Professor
References
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Greenberg JA, Manson JE, Neuhouser ML, Tinker L, Eaton C, Johnson KC, Shikany JM. Chocolate intake and heart disease and stroke in the Women's Health Initiative: a prospective analysis. Am J Clin Nutr. 2018 Jul 1;108(1):41-48. doi: 10.1093/ajcn/nqy073.
Other Identifiers
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438347-3
Identifier Type: -
Identifier Source: org_study_id