Validation of a Revised Food Frequency Questionnaire (FFQ)

• ClinicalTrials.gov Identifier: NCT02693184
• Recruitment Status: Completed
• First Posted: February 26, 2016
• Last Update Posted: May 24, 2022
• Sponsor: University of Nebraska
• Information provided by (Responsible Party): Laura Armas MD, MS, University of Nebraska

Study Description

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.

Condition or disease	Intervention/treatment
Osteoporosis; Nutrition	Other: Full length Block 2014 Food Frequency Questionnaire; Other: Revised Calcium, Vitamin D and Protein Screener

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 31 participants
• Observational Model: Case-Crossover
• Time Perspective: Prospective
• Official Title: Validation of a Revised Food Frequency Questionnaire in a Population of Elderly Men and Women With Fragility Fractures and Correlation With Bone Mineral Density and Biochemical Markers
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: April 2018
• Actual Study Completion Date: June 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
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).	Other: 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.; Other: Revised Calcium, Vitamin D and Protein Screener; The food list includes 29 food items and 5 supplements

Outcome Measures

Primary Outcome Measures :

1. Agreement of the 2 FFQs on protein intake [ Time Frame: 1 year ]
   Protein intake will be assessed with 2 different methods
2. Agreement of the 2 FFQs on calcium intake [ Time Frame: 1 year ]
   Calcium intake will be assessed with 2 different methods
3. Agreement of the 2 FFQs on vitamin D intake [ Time Frame: 1 year ]
   Vitamin D intake will be assessed with 2 different methods

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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).

Contacts and Locations

Locations

United States, Nebraska

University of Nebraska

Omaha, Nebraska, United States

Sponsors and Collaborators

University of Nebraska

Investigators

• Principal Investigator: Laura AG Armas, MD,MS; University of Nebraska

More Information

• Responsible Party: Laura Armas MD, MS, Associate Professor, University of Nebraska
• ClinicalTrials.gov Identifier: NCT02693184
• Other Study ID Numbers: 117-16
• First Posted: February 26, 2016
• Last Update Posted: May 24, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The participant will be sent a letter at the end of study detailing their calcium, protein and vitamin D intake reported on the FFQ

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Vitamin D; Calcium; Vitamins; Micronutrients; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Bone Density Conservation Agents