Osteoporosis, Age-RelatedNCT05197244
A Culinary Intervention for Bone Health
A study testing Culinary Medicine Intervention in people with Osteoporosis, Age-Related and Osteoporosis Risk, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis, Age-Related, Osteoporosis Risk
- What is being tested?
- Culinary Medicine Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jul 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Pilot Study of 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.
Read the 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.
- Conditions
- Osteoporosis, Age-Related, Osteoporosis Risk
- Being tested
- Culinary Medicine Intervention
- Keywords
- osteoporosis, fracture, culinary nutrition, culinary medicine, teaching kitchen, nutrition
- Medical subject headings
- Osteoporosis, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culinary Medicine InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Culinary Medicine Intervention | Experimental | Participants will attend a 2-hour hands-on cooking class in additional to usual care. Receives: Behavioral: Culinary Medicine Intervention |
| Control | No intervention | Participants will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment capacity
Proportion of total referrals who meet criteria for eligibility screening
Measured: Baseline
Intervention reach
Proportion of eligible individuals who agree to participate in study
Measured: Baseline
Intervention fidelity
Proportion of participants who complete study procedures
Measured: 3 months
Intervention satisfaction
Proportion of the intervention group who indicate that they are satisfied with their experience in the culinary medicine class
Measured: 3 months
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
Measured: 3 months
Secondary outcomes (5)
Readiness to change home cooking patterns
Proportion of participants who plan to make a change in home cooking patterns
Measured: Immediately post-intervention
Readiness to change diet
Proportion of participants who plan to make a change in diet
Measured: Immediately post-intervention
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)
Measured: Immediately post-intervention
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)
Measured: Immediately post-intervention
Nutrition education needs
Proportion of participants requesting additional education regarding nutrition and bone health
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start15 Jul 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, Age-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emma O Billington, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197244
- Sponsor's protocol ID
- REB21-1332
- Status last verified
- May 2023
- First submitted
- 10 Dec 2021
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study of a Culinary Intervention for Bone Health
- ClinicalTrials.gov ID
- NCT05197244
- Acronym / sponsor ID
- REB21-1332
- Conditions
- Osteoporosis, Age-Related, Osteoporosis Risk
- Keywords
- osteoporosis, fracture, culinary nutrition, culinary medicine, teaching kitchen, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Culinary Medicine Intervention | Experimental | Behavioral: Culinary Medicine InterventionParticipants will attend a 2-hour hands-on cooking class in additional to usual care. |
| Control | No intervention | –Participants will receive usual care. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culinary Medicine InterventionA 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. | Behavioural | Culinary Medicine Intervention |
Primary outcome
Recruitment capacity
Time frame: Baseline
Proportion of total referrals who meet criteria for eligibility screening
Intervention reach
Time frame: Baseline
Proportion of eligible individuals who agree to participate in study
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
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
5 secondary outcomes
Readiness to change home cooking patterns
Time frame: Immediately post-intervention
Readiness to change diet
Time frame: Immediately post-intervention
Confidence in ability to change home cooking patterns
Time frame: Immediately post-intervention
Confidence in ability to change diet
Time frame: Immediately post-intervention
Nutrition education needs
Time frame: Immediately post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma O Billington, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culinary Medicine Intervention in people with Osteoporosis, Age-Related and Osteoporosis Risk, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment capacity (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.