A Culinary Intervention for Bone Health

Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health

This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass.

Study Overview

• Status: Completed
• Conditions: Osteoporosis Risk; Osteoporosis, Age-Related
• Intervention / Treatment: Behavioral: Culinary Medicine Intervention

Detailed Description

This is a randomized, controlled pilot study to evaluate the feasibility and acceptability of a single 2-hour culinary medicine intervention for bone health among individuals with age-associated low bone mass. A total of 40 individuals referred to a tertiary osteoporosis centre for age-associated low bone mass will be will be recruited and randomized 1:1 to attend either: 1) a 2-hour hands-on culinary medicine program at a hospital-based teaching kitchen followed by three monthly virtual group meetings, each lasting 30 minutes and led by the facilitator of the culinary nutrition program (intervention group), or, 2) not to attend the culinary nutrition program (control group). Baseline data will be collected at the time of recruitment, and both the intervention and control group will be followed for 3 months.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults referred to local tertiary osteoporosis centre for assessment of age-associated low bone mass or assessment of fracture risk
• Women must be postmenopausal (i.e. documented history of surgical menopause, or at least 12 months since last menstrual period), men must be age ≥45 years
• Self-determined ability to learn in classroom and kitchen environments and a virtual (video) learning environment
• Reliable access to hardware, software, and internet connection required to participate in an interactive virtual (video) conference
• Ability to attend local hospital-based teaching kitchen for culinary medicine intervention
• Willing to participate in a culinary medicine intervention and provide informed consent

Exclusion Criteria:

• Complex metabolic bone disease or on dialysis for end-stage kidney disease
• Exclusion on the basis of other active health conditions which may present a contraindication to intake of whole and calcium-rich foods will be determined by the medical team on a case-by-case basis
• Deemed by research team to be unable to learn in a group classroom or kitchen environment
• Unable to communicate in English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will receive usual care.
Experimental: Culinary Medicine Intervention; Participants will attend a 2-hour hands-on cooking class in additional to usual care.	Behavioral: Culinary Medicine Intervention; A 2-hour practical culinary medicine program facilitated by a culinary dietitian at a hospital-based teaching kitchen, followed by 3 virtual group follow-up sessions occurring monthly, each lasting approximately 30 minutes. The follow-up sessions will be facilitated by a culinary dietitian and will be conducted using a secure telephone/video conference platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment capacity	Proportion of total referrals who meet criteria for eligibility screening	Baseline
Intervention reach	Proportion of eligible individuals who agree to participate in study	Baseline
Intervention fidelity	Proportion of participants who complete study procedures	3 months
Intervention satisfaction	Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class	3 months
Intervention mode and dose	Proportion of the intervention group who would have preferred to attend multiple hands-on culinary medicine sessions rather than a single session	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness to change home cooking patterns	Proportion of participants who plan to make a change in home cooking patterns	Immediately post-intervention
Readiness to change diet	Proportion of participants who plan to make a change in diet	Immediately post-intervention
Confidence in ability to change home cooking patterns	Confidence in ability to change home cooking patterns graded on a scale of 1 (not at all confident) to 10 (very confident)	Immediately post-intervention
Confidence in ability to change diet	Confidence in ability to change diet graded on a scale of 1 (not at all confident) to 10 (very confident)	Immediately post-intervention
Nutrition education needs	Proportion of participants requesting additional education regarding nutrition and bone health	Immediately post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meals eaten at home	Change in number of meals eaten each week that are prepared at home	3 months
Home cooking behaviours	Change in number of meals personally prepared by participant "from scratch" each week	3 months
Dietary patterns	Change in weekly intake of fruits, vegetables, dairy (including fermented dairy)	3 months
Food skills	Change in score on a modified food skills questionnaire (higher score means better food skills)	3 months
Overall diet quality	Change in overall diet quality (assessed using 24-hour food recall)	3 months
Dietary calcium intake	Change in daily dietary calcium intake (assessed via 24-hour dietary recall)	3 months
Dietary vitamin D intake	Change in daily dietary vitamin D intake (assessed via 24-hour dietary recall)	3 months
Dietary protein intake	Change in daily dietary protein intake (assessed via 24-hour dietary recall)	3 months
Calcium supplement use	Proportion of participants taking a calcium supplement	3 months
Vitamin D supplement use	Proportion of participants taking a vitamin D supplement	3 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Emma O Billington, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: nutrition; osteoporosis; fracture; teaching kitchen; culinary medicine; culinary nutrition
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: REB21-1332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No