A Culinary Intervention for Bone Health

NCT ID: NCT05197244

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-04-30

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.

Conditions

Osteoporosis, Age-Related; Osteoporosis Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Culinary Medicine Intervention

Participants will attend a 2-hour hands-on cooking class in additional to usual care.

Group Type: EXPERIMENTAL

Culinary Medicine Intervention

Intervention Type: BEHAVIORAL

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.

Control

Participants will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emma O Billington, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

REB21-1332

Identifier Type: -

Identifier Source: org_study_id