Chocolate and CVD Risk in Postmenopausal Women

Sponsor

Brooklyn College of the City University of New York (Other)

Overall Status

Completed

CT.gov ID

NCT03453073

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), Department of Health and Human Services (U.S. Fed)

83,310

Enrollment

42.5

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Heart Disease Stroke	Behavioral: chocolate consumption level Other: physician diagnosis of first occurrence of serious chronic disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

83310 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

Chocolate Intake and Heart Disease and Stroke in the Women's Health Initiative: a Prospective Analysis

Actual Study Start Date :

Dec 15, 2014

Actual Primary Completion Date :

Apr 30, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
chocolate consumption level referent women who ate 1 oz. (28.35 g) of chocolate <1 time/month	Behavioral: 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	Behavioral: 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,	Behavioral: 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	Behavioral: 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	Behavioral: 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	Other: physician diagnosis of first occurrence of serious chronic disease
Physician diagnosis Incidence of serious chronic disease prior to visit 3	Other: physician diagnosis of first occurrence of serious chronic disease
Younger Age<65 years at follow-up baseline	Behavioral: chocolate consumption level level of consumption of 1 oz. of chocolate, as assessed at baseline
Older Age>=65 years at follow-up baseline	Behavioral: chocolate consumption level level of consumption of 1 oz. of chocolate, as assessed at baseline

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 79 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Postmenopausal women
age between 50 and 79 years
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:

implausible energy intakes, defined as <600 kcal/d or >5,000 kcal/d;
implausible body mass indices (BMI) (<15 or >50 kg/m2)
implausible height<122 cm (4 ft.)
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.
missing data on preexisting major chronic disease or any exposure, outcome or confounder variables.