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Clinical Trials/NCT05197244
NCT05197244
Completed
Not Applicable

Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health

University of Calgary1 site in 1 country40 target enrollmentJuly 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis, Age-Related
Sponsor
University of Calgary
Enrollment
40
Locations
1
Primary Endpoint
Intervention reach
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Intervention reach

Time Frame: Baseline

Proportion of eligible individuals who agree to participate in study

Intervention mode and dose

Time Frame: 3 months

Proportion of the intervention group who would have preferred to attend multiple hands-on culinary medicine sessions rather than a single session

Recruitment capacity

Time Frame: Baseline

Proportion of total referrals who meet criteria for eligibility screening

Intervention fidelity

Time Frame: 3 months

Proportion of participants who complete study procedures

Intervention satisfaction

Time Frame: 3 months

Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class

Secondary Outcomes

  • Confidence in ability to change home cooking patterns(Immediately post-intervention)
  • Readiness to change home cooking patterns(Immediately post-intervention)
  • Readiness to change diet(Immediately post-intervention)
  • Confidence in ability to change diet(Immediately post-intervention)
  • Nutrition education needs(Immediately post-intervention)

Study Sites (1)

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