Chocolate and CVD Risk in Postmenopausal Women

NCT03453073 | Completed

• 1 other identifier: 438347-3
• Study Type: observational
• Target: 83,310
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiovascular Disease; Heart Disease; Stroke

Keywords

Coronary heart disease; stroke; chocolate consumption; postmenopausal women; nutrition; dietary intake; epidemiology

Outcome Measures

Primary Outcomes (7)

• incidence of heart disease

  physician adjudicated first occurrence of, or death due to, heart disease

  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

  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

  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 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 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 between the baseline and year 3, average 3 years

• change in BMI

  change in BMI between visit 1 and 3

  time between the baseline and year 3, average 3 years

Study Arms (9)

chocolate consumption level referent

women who ate 1 oz. (28.35 g) of chocolate \<1 time/month

Behavioral: chocolate consumption level

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

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

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

chocolate consumption level 5

women who ate 1 oz. (28.35 g) of chocolate \>3 times/week

Behavioral: chocolate consumption level

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

Older

Age\>=65 years at follow-up baseline

Behavioral: chocolate consumption level

Interventions

chocolate consumption level BEHAVIORAL

level of consumption of 1 oz. of chocolate, as assessed at baseline

Older; Younger; chocolate consumption level 2; chocolate consumption level 3; chocolate consumption level 4; chocolate consumption level 5; chocolate consumption level referent

physician diagnosis of first occurrence of serious chronic disease OTHER

No physician diagnosis; Physician diagnosis

Eligibility Criteria

• Age: 55 Years - 79 Years
• Gender Eligibility Details: postmenopausal women 50-79 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community residents

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brooklyn College of the City University of New York: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Department of Health and Human Services: collaborator

Related Publications (1)

• 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.

  PMID: 29931040 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Stroke; Coronary Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Myocardial Ischemia

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2018
• First Posted: March 5, 2018
• Study Start: December 15, 2014
• Primary Completion: April 30, 2018
• Study Completion: July 1, 2018
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share