Diet and Hip Fracture Risk in the United Kingdom Women's Cohort
NCT ID: NCT05081466
Last Updated: 2022-09-23
Study Results
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Basic Information
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COMPLETED
35372 participants
OBSERVATIONAL
1995-01-15
2022-07-31
Brief Summary
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Detailed Description
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Research plan and methods: The investigators will utilise dietary and lifestyle data from the United Kingdom Women's Cohort which recruited 35,372 middle-aged women between 1995-1998. This data has been linked with Hospital Episode Statistics to provide hip fracture data of participants.
Cox regression models will be applied to explore potential associations between dietary factors and hip fracture incidence. Dietary factors will be modelled both as categorical and continuous so that models can be fit comparing the risk of hip fracture between categories of intakes and per increment increase in exposure intake (linear dose-response). Cubic splines will be used to model non-linear associations for dietary intake of fruits, vegetables, tea, and coffee since previous research has suggested possible non-linear associations for these variables.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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United Kingdom Women's Cohort
United Kingdom Women's Cohort Study. No interventions are to be administered in this observational prospective cohort study.
Dietary pattern
(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)
Fruit and vegetable intake
Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire
Meat intake
Red meat, poultry, processed meat from food frequency questionnaire
Fish intake
Intake of fish from food frequency questionnaire
Egg intake
Intake of eggs from food frequency questionnaire
Dairy intake
Intake of dairy products from food frequency questionnaire
Tea intake
Intake of tea (drink) from food frequency questionnaire
Coffee intake
Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire
Tea and coffee intake
Combined intake of tea and coffee from food frequency questionnaire
Protein intake
Estimated intake of protein, derived from food frequency questionnaire
Calcium intake
Estimated intake of calcium, derived from food frequency questionnaire
Vitamin D intake
Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake
Interventions
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Dietary pattern
(regular meat-eater, occasional meat-eater, fish-eater, vegetarian, and vegan)
Fruit and vegetable intake
Intake of fruits, vegetables, fruits and vegetables combined from food frequency questionnaire
Meat intake
Red meat, poultry, processed meat from food frequency questionnaire
Fish intake
Intake of fish from food frequency questionnaire
Egg intake
Intake of eggs from food frequency questionnaire
Dairy intake
Intake of dairy products from food frequency questionnaire
Tea intake
Intake of tea (drink) from food frequency questionnaire
Coffee intake
Intake of coffee (caffeinated or decaffeinated) from food frequency questionnaire
Tea and coffee intake
Combined intake of tea and coffee from food frequency questionnaire
Protein intake
Estimated intake of protein, derived from food frequency questionnaire
Calcium intake
Estimated intake of calcium, derived from food frequency questionnaire
Vitamin D intake
Estimated intake of vitamin D, derived from food frequency questionnaire and any recorded supplemental intake
Eligibility Criteria
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Inclusion Criteria
* Ages 35 - 69 years at time of recruitment
* Able to provide informed consent
Exclusion Criteria
* Not a resident of England
* Unable to link dietary and lifestyle data with hospital episode data
* Missing covariate data
* Hip fracture or osteoporosis prevalence before or on the date of recruitment
36 Years
69 Years
FEMALE
Yes
Sponsors
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University of Leeds
OTHER
Responsible Party
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Darren Greenwood
Senior Lecturer in Biostatistics
Locations
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University of Leeds
Leeds, West Yorkshire, United Kingdom
Countries
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References
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Webster J, Greenwood DC, Cade JE. Risk of hip fracture in meat-eaters, pescatarians, and vegetarians: results from the UK Women's Cohort Study. BMC Med. 2022 Aug 11;20(1):275. doi: 10.1186/s12916-022-02468-0.
Webster J, Greenwood DC, Cade JE. Foods, nutrients and hip fracture risk: A prospective study of middle-aged women. Clin Nutr. 2022 Dec;41(12):2825-2832. doi: 10.1016/j.clnu.2022.11.008. Epub 2022 Nov 9.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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HRA 17/YH/0144
Identifier Type: -
Identifier Source: org_study_id
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