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Completed

NCT Number: NCT05197244

A Culinary Intervention for Bone Health

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culinary Medicine Intervention

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.

Primary outcomes

  1. Recruitment capacity

    Time frame: Baseline

    Proportion of total referrals who meet criteria for eligibility screening

  2. Intervention reach

    Time frame: Baseline

    Proportion of eligible individuals who agree to participate in study

  3. Intervention fidelity

    Time frame: 3 months

    Proportion of participants who complete study procedures

  4. 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

  5. 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

Secondary outcomes

  1. Readiness to change home cooking patterns

    Time frame: Immediately post-intervention

    Proportion of participants who plan to make a change in home cooking patterns

  2. Readiness to change diet

    Time frame: Immediately post-intervention

    Proportion of participants who plan to make a change in diet

  3. Confidence in ability to change home cooking patterns

    Time frame: Immediately post-intervention

    Confidence in ability to change home cooking patterns graded on a scale of 1 (not at all confident) to 10 (very confident)

  4. Confidence in ability to change diet

    Time frame: Immediately post-intervention

    Confidence in ability to change diet graded on a scale of 1 (not at all confident) to 10 (very confident)

  5. Nutrition education needs

    Time frame: Immediately post-intervention

    Proportion of participants requesting additional education regarding nutrition and bone health

Other outcomes

  1. Meals eaten at home

    Time frame: 3 months

    Change in number of meals eaten each week that are prepared at home

  2. Home cooking behaviours

    Time frame: 3 months

    Change in number of meals personally prepared by participant "from scratch" each week

  3. Dietary patterns

    Time frame: 3 months

    Change in weekly intake of fruits, vegetables, dairy (including fermented dairy)

  4. Food skills

    Time frame: 3 months

    Change in score on a modified food skills questionnaire (higher score means better food skills)

  5. Overall diet quality

    Time frame: 3 months

    Change in overall diet quality (assessed using 24-hour food recall)

  6. Dietary calcium intake

    Time frame: 3 months

    Change in daily dietary calcium intake (assessed via 24-hour dietary recall)

  7. Dietary vitamin D intake

    Time frame: 3 months

    Change in daily dietary vitamin D intake (assessed via 24-hour dietary recall)

  8. Dietary protein intake

    Time frame: 3 months

    Change in daily dietary protein intake (assessed via 24-hour dietary recall)

  9. Calcium supplement use

    Time frame: 3 months

    Proportion of participants taking a calcium supplement

  10. Vitamin D supplement use

    Time frame: 3 months

    Proportion of participants taking a vitamin D supplement

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2022
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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