A Culinary Intervention for Bone Health

May 9, 2023 updated by: University of Calgary

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • University Of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Participants will receive usual care.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment capacity
Time Frame: Baseline
Proportion of total referrals who meet criteria for eligibility screening
Baseline
Intervention reach
Time Frame: Baseline
Proportion of eligible individuals who agree to participate in study
Baseline
Intervention fidelity
Time Frame: 3 months
Proportion of participants who complete study procedures
3 months
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
3 months
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
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Readiness to change home cooking patterns
Time Frame: Immediately post-intervention
Proportion of participants who plan to make a change in home cooking patterns
Immediately post-intervention
Readiness to change diet
Time Frame: Immediately post-intervention
Proportion of participants who plan to make a change in diet
Immediately post-intervention
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)
Immediately post-intervention
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)
Immediately post-intervention
Nutrition education needs
Time Frame: Immediately post-intervention
Proportion of participants requesting additional education regarding nutrition and bone health
Immediately post-intervention

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Meals eaten at home
Time Frame: 3 months
Change in number of meals eaten each week that are prepared at home
3 months
Home cooking behaviours
Time Frame: 3 months
Change in number of meals personally prepared by participant "from scratch" each week
3 months
Dietary patterns
Time Frame: 3 months
Change in weekly intake of fruits, vegetables, dairy (including fermented dairy)
3 months
Food skills
Time Frame: 3 months
Change in score on a modified food skills questionnaire (higher score means better food skills)
3 months
Overall diet quality
Time Frame: 3 months
Change in overall diet quality (assessed using 24-hour food recall)
3 months
Dietary calcium intake
Time Frame: 3 months
Change in daily dietary calcium intake (assessed via 24-hour dietary recall)
3 months
Dietary vitamin D intake
Time Frame: 3 months
Change in daily dietary vitamin D intake (assessed via 24-hour dietary recall)
3 months
Dietary protein intake
Time Frame: 3 months
Change in daily dietary protein intake (assessed via 24-hour dietary recall)
3 months
Calcium supplement use
Time Frame: 3 months
Proportion of participants taking a calcium supplement
3 months
Vitamin D supplement use
Time Frame: 3 months
Proportion of participants taking a vitamin D supplement
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Calgary

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emma O Billington, MD, University Of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB21-1332

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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