Back to resultsA Culinary Intervention for Bone Health
Primary Purpose
Osteoporosis, Age-Related, Osteoporosis Risk
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Culinary Medicine Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis, Age-Related focused on measuring osteoporosis, fracture, culinary nutrition, culinary medicine, teaching kitchen, nutrition
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
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Culinary Medicine Intervention
Control
Arm Description
Participants will attend a 2-hour hands-on cooking class in additional to usual care.
Participants will receive usual care.
Outcomes
Primary Outcome Measures
Recruitment capacity
Proportion of total referrals who meet criteria for eligibility screening
Intervention reach
Proportion of eligible individuals who agree to participate in study
Intervention fidelity
Proportion of participants who complete study procedures
Intervention satisfaction
Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class
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
Secondary Outcome Measures
Readiness to change home cooking patterns
Proportion of participants who plan to make a change in home cooking patterns
Readiness to change diet
Proportion of participants who plan to make a change in diet
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)
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)
Nutrition education needs
Proportion of participants requesting additional education regarding nutrition and bone health
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05197244
Brief Title
A Culinary Intervention for Bone Health
Official Title
Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Age-Related, Osteoporosis Risk
Keywords
osteoporosis, fracture, culinary nutrition, culinary medicine, teaching kitchen, nutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Culinary Medicine Intervention
Arm Type
Experimental
Arm Description
Participants will attend a 2-hour hands-on cooking class in additional to usual care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Culinary Medicine Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment capacity
Description
Proportion of total referrals who meet criteria for eligibility screening
Time Frame
Baseline
Title
Intervention reach
Description
Proportion of eligible individuals who agree to participate in study
Time Frame
Baseline
Title
Intervention fidelity
Description
Proportion of participants who complete study procedures
Time Frame
3 months
Title
Intervention satisfaction
Description
Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class
Time Frame
3 months
Title
Intervention mode and dose
Description
Proportion of the intervention group who would have preferred to attend multiple hands-on culinary medicine sessions rather than a single session
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Readiness to change home cooking patterns
Description
Proportion of participants who plan to make a change in home cooking patterns
Time Frame
Immediately post-intervention
Title
Readiness to change diet
Description
Proportion of participants who plan to make a change in diet
Time Frame
Immediately post-intervention
Title
Confidence in ability to change home cooking patterns
Description
Confidence in ability to change home cooking patterns graded on a scale of 1 (not at all confident) to 10 (very confident)
Time Frame
Immediately post-intervention
Title
Confidence in ability to change diet
Description
Confidence in ability to change diet graded on a scale of 1 (not at all confident) to 10 (very confident)
Time Frame
Immediately post-intervention
Title
Nutrition education needs
Description
Proportion of participants requesting additional education regarding nutrition and bone health
Time Frame
Immediately post-intervention
Other Pre-specified Outcome Measures:
Title
Meals eaten at home
Description
Change in number of meals eaten each week that are prepared at home
Time Frame
3 months
Title
Home cooking behaviours
Description
Change in number of meals personally prepared by participant "from scratch" each week
Time Frame
3 months
Title
Dietary patterns
Description
Change in weekly intake of fruits, vegetables, dairy (including fermented dairy)
Time Frame
3 months
Title
Food skills
Description
Change in score on a modified food skills questionnaire (higher score means better food skills)
Time Frame
3 months
Title
Overall diet quality
Description
Change in overall diet quality (assessed using 24-hour food recall)
Time Frame
3 months
Title
Dietary calcium intake
Description
Change in daily dietary calcium intake (assessed via 24-hour dietary recall)
Time Frame
3 months
Title
Dietary vitamin D intake
Description
Change in daily dietary vitamin D intake (assessed via 24-hour dietary recall)
Time Frame
3 months
Title
Dietary protein intake
Description
Change in daily dietary protein intake (assessed via 24-hour dietary recall)
Time Frame
3 months
Title
Calcium supplement use
Description
Proportion of participants taking a calcium supplement
Time Frame
3 months
Title
Vitamin D supplement use
Description
Proportion of participants taking a vitamin D supplement
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emma O Billington, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Culinary Intervention for Bone Health
We'll reach out to this number within 24 hrs