A Culinary Intervention for Bone Health

Osteoporosis Risk Clinical Trial

Official title:

Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197244
• Other study ID #: REB21-1332
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis Risk
• Osteoporosis, Age-Related

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Meals eaten at home	Change in number of meals eaten each week that are prepared at home	3 months
Other	Home cooking behaviours	Change in number of meals personally prepared by participant "from scratch" each week	3 months
Other	Dietary patterns	Change in weekly intake of fruits, vegetables, dairy (including fermented dairy)	3 months
Other	Food skills	Change in score on a modified food skills questionnaire (higher score means better food skills)	3 months
Other	Overall diet quality	Change in overall diet quality (assessed using 24-hour food recall)	3 months
Other	Dietary calcium intake	Change in daily dietary calcium intake (assessed via 24-hour dietary recall)	3 months
Other	Dietary vitamin D intake	Change in daily dietary vitamin D intake (assessed via 24-hour dietary recall)	3 months
Other	Dietary protein intake	Change in daily dietary protein intake (assessed via 24-hour dietary recall)	3 months
Other	Calcium supplement use	Proportion of participants taking a calcium supplement	3 months
Other	Vitamin D supplement use	Proportion of participants taking a vitamin D supplement	3 months
Primary	Recruitment capacity	Proportion of total referrals who meet criteria for eligibility screening	Baseline
Primary	Intervention reach	Proportion of eligible individuals who agree to participate in study	Baseline
Primary	Intervention fidelity	Proportion of participants who complete study procedures	3 months
Primary	Intervention satisfaction	Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class	3 months
Primary	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	Readiness to change home cooking patterns	Proportion of participants who plan to make a change in home cooking patterns	Immediately post-intervention
Secondary	Readiness to change diet	Proportion of participants who plan to make a change in diet	Immediately post-intervention
Secondary	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
Secondary	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
Secondary	Nutrition education needs	Proportion of participants requesting additional education regarding nutrition and bone health	Immediately post-intervention