A Culinary Intervention for Bone Health

Not Applicable

Completed

• Conditions: Osteoporosis, Age-Related; Osteoporosis Risk
• Interventions: Behavioral: Culinary Medicine Intervention

• Registration Number: NCT05197244
• Lead Sponsor: University of Calgary

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-19
• Study Start: 2022-07-15
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culinary Medicine Intervention	Culinary Medicine Intervention	Participants will attend a 2-hour hands-on cooking class in additional to usual care.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada