A Culinary Intervention for Bone Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health

Conditions
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Osteoporosis, Age-Related, Osteoporosis Risk

Intervention / Treatment
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* Behavioral: Culinary Medicine Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culinary Medicine Intervention<br>Participants will attend a 2-hour hands-on cooking class in additional to usual care. | Behavioral: Culinary Medicine Intervention<br>* 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.<br>|
| No Intervention: Control<br>Participants will receive usual care. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, fracture, culinary nutrition, culinary medicine, teaching kitchen, nutrition