Validation of a Revised Food Frequency Questionnaire

NCT ID: NCT02693184

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-25
• Study Completion Date: 2018-06-01

Brief Summary

The purpose of this study is to validate a revised food frequency questionnaire that is designed to capture vitamin D, calcium and protein intake in a population of elderly men and women with fragility fractures. Protein, calcium and protein intake will be correlated with biochemical measures and bone mineral density measured by DXA.

Detailed Description

The purpose of this study is to validate a revised food frequency questionnaire that is designed to capture vitamin D, calcium and protein intake in a population of elderly men and women with fragility fractures. Protein, calcium and protein intake will be correlated with biochemical measures and bone mineral density measured by DXA.

Eligibility Criteria) Forty-five eligible participants will be recruited from the endocrine referrals for osteoporosis/fracture. They will be men and women, age >65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less). They will be English speaking. They will need to have the mental capacity to recall events, (MMSE score ³24).11 They will need to have a telephone and the ability to answer questions over a phone. They will not have secondary causes of fragility fracture such as malabsorption (celiac disease, bariatric surgery), liver disease, organ transplant, hyperparathyroidism, multiple myeloma, current cancer diagnosis, or alcoholism. They will not have renal disease requiring dialysis (as the dietary requirement of these patients is quite different from the general elderly population). They will not be on tubefeeds of any kind (although supplemental food such as Ensure is allowed). Interventions and Evaluations) The evaluations will include a history and physical exam, and a mini mental status exam. Two telephone interviews will be conducted ~ 4 weeks apart during which the Block 2014 questionnaire will be given and the revised screener will be given. The order that the questionnaires are given will be randomized. As part of the standard of care workup for osteoporosis, a biochemical workup including 25-hydroxyvitamin D, comprehensive metabolic profile, bone specific alkaline phosphatase (a bone remodeling marker), phosphorus and transglutaminase IgA (to rule out celiac disease), and DXA scan for bone mineral density (BMD) measurement will be done. The BMD by DXA and 25-hydroxyvitamin D will be correlated to protein, calcium and vitamin D intake obtained by the Block 2014.

Conditions

Osteoporosis; Nutrition

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Fragility Fracture Case

Men and women, age \>65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less).

Full length Block 2014 Food Frequency Questionnaire

Intervention Type: OTHER

The food and beverage list includes 127 items, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.

Revised Calcium, Vitamin D and Protein Screener

Intervention Type: OTHER

The food list includes 29 food items and 5 supplements

Interventions

Full length Block 2014 Food Frequency Questionnaire

The food and beverage list includes 127 items, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.

Intervention Type: OTHER

Revised Calcium, Vitamin D and Protein Screener

The food list includes 29 food items and 5 supplements

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• They will be men and women, age >65 years with a fragility fracture (defined as a fracture sustained after a fall from a standing height or less). They will be English speaking. They will need to have the mental capacity to recall events, (MMSE score >24).11 They will need to have a telephone and the ability to answer questions over a phone.

Exclusion Criteria

• They will not have secondary causes of fragility fracture such as malabsorption (celiac disease, bariatric surgery), liver disease, organ transplant, hyperparathyroidism, multiple myeloma, current cancer diagnosis, or alcoholism. They will not have renal disease requiring dialysis (as the dietary requirement of these patients is quite different from the general elderly population). They will not be on tubefeeds of any kind (although supplemental food such as Ensure is allowed).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura AG Armas, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0117-16-EP

Identifier Type: -

Identifier Source: org_study_id