CompletedNot Applicable

Chocolate and CVD Risk in Postmenopausal Women

83,310 participantsStarted 2014-12-15

Plain-language 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.

Who can participate

Age range

55 Years – 79 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

incidence of heart disease

Timeframe: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

incidence of stroke

Timeframe: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

incidence of heart disease or stroke

Timeframe: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

change in chocolate intake

Timeframe: time between the baseline and visit 3, average 3 years

change in dietary energy intake

Timeframe: time between the baseline and year 3, average 3 years

change in dietary fat intake

Timeframe: time between the baseline and year 3, average 3 years

change in BMI

Timeframe: time between the baseline and year 3, average 3 years

Trial details

NCT IDNCT03453073

SponsorBrooklyn College of the City University of New York

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-04-30

View on ClinicalTrials.gov More Cardiovascular Disease trials

Who can participate

Age range

55 Years – 79 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

incidence of heart disease

Timeframe: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

incidence of stroke

Timeframe: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

incidence of heart disease or stroke

Timeframe: between the baseline survey (1993-8) & September 30, 2013, average 13.4 years

change in chocolate intake

Timeframe: time between the baseline and visit 3, average 3 years

change in dietary energy intake

Timeframe: time between the baseline and year 3, average 3 years

change in dietary fat intake

Timeframe: time between the baseline and year 3, average 3 years

change in BMI

Timeframe: time between the baseline and year 3, average 3 years