Clinical trial NCT05197244: A Culinary Intervention for Bone Health
Official title: Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis, Age-Related
Osteoporosis Risk
Keywords: osteoporosis
fracture
culinary nutrition
culinary medicine
teaching kitchen
nutrition
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recruitment capacity
timeFrame: Baseline
measure: Intervention reach
timeFrame: Baseline
measure: Intervention fidelity
timeFrame: 3 months
measure: Intervention satisfaction
timeFrame: 3 months
measure: Intervention mode and dose
timeFrame: 3 months
Secondary outcomes:
measure: Readiness to change home cooking patterns
timeFrame: Immediately post-intervention
measure: Readiness to change diet
timeFrame: Immediately post-intervention
measure: Confidence in ability to change home cooking patterns
timeFrame: Immediately post-intervention
measure: Confidence in ability to change diet
timeFrame: Immediately post-intervention
measure: Nutrition education needs
timeFrame: Immediately post-intervention
Other outcomes:
measure: Meals eaten at home
timeFrame: 3 months
measure: Home cooking behaviours
timeFrame: 3 months
measure: Dietary patterns
timeFrame: 3 months
measure: Food skills
timeFrame: 3 months
measure: Overall diet quality
timeFrame: 3 months
measure: Dietary calcium intake
timeFrame: 3 months
measure: Dietary vitamin D intake
timeFrame: 3 months
measure: Dietary protein intake
timeFrame: 3 months
measure: Calcium supplement use
timeFrame: 3 months
measure: Vitamin D supplement use
timeFrame: 3 months
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Emma O Billington, MD
role: PRINCIPAL_INVESTIGATOR
References: