A Culinary Intervention for Bone Health

Sponsor
University of Calgary (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05197244
Collaborator
(none)
40
2
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Culinary Medicine Intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-arm randomized controlled trialTwo-arm randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Culinary Medicine Intervention

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

Behavioral: 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.

No Intervention: Control

Participants will receive usual care.

Outcome Measures

Primary Outcome Measures

  1. Recruitment capacity [Baseline]

    Proportion of total referrals who meet criteria for eligibility screening

  2. Intervention reach [Baseline]

    Proportion of eligible individuals who agree to participate in study

  3. Intervention fidelity [3 months]

    Proportion of participants who complete study procedures

  4. Intervention satisfaction [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 [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 Outcome Measures

  1. Readiness to change home cooking patterns [Immediately post-intervention]

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

  2. Readiness to change diet [Immediately post-intervention]

    Proportion of participants who plan to make a change in diet

  3. Confidence in ability to change home cooking patterns [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 [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 [Immediately post-intervention]

    Proportion of participants requesting additional education regarding nutrition and bone health

Other Outcome Measures

  1. Meals eaten at home [3 months]

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

  2. Home cooking behaviours [3 months]

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

  3. Dietary patterns [3 months]

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

  4. Food skills [3 months]

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

  5. Overall diet quality [3 months]

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

  6. Dietary calcium intake [3 months]

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

  7. Dietary vitamin D intake [3 months]

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

  8. Dietary protein intake [3 months]

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

  9. Calcium supplement use [3 months]

    Proportion of participants taking a calcium supplement

  10. Vitamin D supplement use [3 months]

    Proportion of participants taking a vitamin D supplement

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Calgary

Investigators

  • Principal Investigator: Emma O Billington, MD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Calgary
ClinicalTrials.gov Identifier:
NCT05197244
Other Study ID Numbers:
  • REB21-1332
First Posted:
Jan 19, 2022
Last Update Posted:
Jan 19, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Calgary
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022