MalnutritionM3NCT02800291
Making the Most of Mealtimes Determinants of Food Intake
An observational study of Malnutrition, run by University of Waterloo.
Trial summary
M3 is a multi-site cross sectional study. Data were collected form 640 residents in 32 homes in Canada. The primary purpose of this study was to identify food intake in residents and compare this to recommendations, as well as determine influential determinants of food intake. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 640 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Participants were residents in long term care. Eligible residents were medically stable, living in the selected units from the participating homes. They had to be reside in the home for more than 1 month and not be on tube feeding or be considered at the end of life.
Who may be able to join
- medically stable living in selected units, residing in home for more than one month consent to participate
Who cannot join
- considered end of life by staff; tube feeding
About this study
Official title: Making the Most of Mealtimes (M3): Determinants of Food Intake in Long Term Care
M3 is a multi-site cross sectional study. Data were collected form 640 residents in 32 homes in Canada. The primary purpose of this study was to identify food intake in residents and compare this to recommendations, as well as determine influential determinants of food intake.
Read the detailed description
This cross-sectional study has collected in-depth data at the resident, dining room, staff, and home level, focused on determinants of food intake. Dietary intake is based on three non-consecutive days of weighed and estimated food intake. Oral health and dyshphagia risk are assessed. Person directed care practices, mealtime environments and home level variables of food cost, production and delivery are ascertained.
- Conditions
- Malnutrition
- Keywords
- food intake
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Malnutrition
Subjective Global Assessment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta, University of Manitoba, Universite de Moncton
- Responsible party
- Principal investigator, Heather Keller, University of Waterloo
- Investigators
- Heather Keller, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800291
- Sponsor's protocol ID
- 20056
- Acronym
- M3
- Status last verified
- Feb 2019
- First submitted
- 7 Jun 2016
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vucea V, Keller HH, Morrison JM, Duncan AM, Duizer LM, Carrier N, Lengyel CO, Slaughter SE. Nutritional quality of regular and pureed menus in Canadian long term care homes: an analysis of the Making the Most of Mealtimes (M3) project. BMC Nutr. 2017 Oct 23;3:80. doi: 10.1186/s40795-017-0198-3. eCollection 2017.
PubMed 32153857Vucea V, Keller HH, Morrison JM, Duizer LM, Duncan AM, Steele CM. Prevalence and Characteristics Associated with Modified Texture Food Use in Long Term Care: An Analysis of Making the Most of Mealtimes (M3) Project. Can J Diet Pract Res. 2019 Sep 1;80(3):104-110. doi: 10.3148/cjdpr-2018-045. Epub 2019 Feb 7.
PubMed 30724101Iuglio S, Keller H, Chaudhury H, Slaughter SE, Lengyel C, Morrison J, Boscart V, Carrier N. Construct validity of the Dining Environment Audit Protocol: a secondary data analysis of the Making Most of Mealtimes (M3) study. BMC Geriatr. 2018 Jan 22;18(1):20. doi: 10.1186/s12877-018-0708-4.
PubMed 29357821Keller HH, Carrier N, Slaughter S, Lengyel C, Steele CM, Duizer L, Brown KS, Chaudhury H, Yoon MN, Duncan AM, Boscart VM, Heckman G, Villalon L. Making the Most of Mealtimes (M3): protocol of a multi-centre cross-sectional study of food intake and its determinants in older adults living in long term care homes. BMC Geriatr. 2017 Jan 13;17(1):15. doi: 10.1186/s12877-016-0401-4.
PubMed 28086754
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making the Most of Mealtimes (M3): Determinants of Food Intake in Long Term Care
- ClinicalTrials.gov ID
- NCT02800291
- Acronym / sponsor ID
- M3 / 20056
- Conditions
- Malnutrition
- Keywords
- food intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta, University of Manitoba, Universite de Moncton
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jun 2016 (estimated)
- 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.
M3 is a multi-site cross sectional study. Data were collected form 640 residents in 32 homes in Canada. The primary purpose of this study was to identify food intake in residents and compare this to recommendations, as well as determine influential determinants of food intake.
Detailed description
This cross-sectional study has collected in-depth data at the resident, dining room, staff, and home level, focused on determinants of food intake. Dietary intake is based on three non-consecutive days of weighed and estimated food intake. Oral health and dyshphagia risk are assessed. Person directed care practices, mealtime environments and home level variables of food cost, production and delivery are ascertained.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants were residents in long term care. Eligible residents were medically stable, living in the selected units from the participating homes. They had to be reside in the home for more than 1 month and not be on tube feeding or be considered at the end of life.
Key inclusion criteria (1 listed)
- medically stable living in selected units, residing in home for more than one month consent to participate
Key exclusion criteria (1 listed)
- considered end of life by staff; tube feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malnutrition
Time frame: 1 month
Subjective Global Assessment
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 5 Feb 2019.
- Derived from this study: PubMed 32153857Vucea V, Keller HH, Morrison JM, Duncan AM, Duizer LM, Carrier N, Lengyel CO, Slaughter SE. Nutritional quality of regular and pureed menus in Canadian long term care homes: an analysis of the Making the Most of Mealtimes (M3) project. BMC Nutr. 2017 Oct 23;3:80. doi: 10.1186/s40795-017-0198-3. eCollection 2017.
- Derived from this study: PubMed 30724101Vucea V, Keller HH, Morrison JM, Duizer LM, Duncan AM, Steele CM. Prevalence and Characteristics Associated with Modified Texture Food Use in Long Term Care: An Analysis of Making the Most of Mealtimes (M3) Project. Can J Diet Pract Res. 2019 Sep 1;80(3):104-110. doi: 10.3148/cjdpr-2018-045. Epub 2019 Feb 7.
- Derived from this study: PubMed 29357821Iuglio S, Keller H, Chaudhury H, Slaughter SE, Lengyel C, Morrison J, Boscart V, Carrier N. Construct validity of the Dining Environment Audit Protocol: a secondary data analysis of the Making Most of Mealtimes (M3) study. BMC Geriatr. 2018 Jan 22;18(1):20. doi: 10.1186/s12877-018-0708-4.
- Derived from this study: PubMed 28086754Keller HH, Carrier N, Slaughter S, Lengyel C, Steele CM, Duizer L, Brown KS, Chaudhury H, Yoon MN, Duncan AM, Boscart VM, Heckman G, Villalon L. Making the Most of Mealtimes (M3): protocol of a multi-centre cross-sectional study of food intake and its determinants in older adults living in long term care homes. BMC Geriatr. 2017 Jan 13;17(1):15. doi: 10.1186/s12877-016-0401-4.
- Primary analysis results on determinants of food intakeLink provided by the sponsor.
- Primary analysis results on determinants of fluid intakeLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Malnutrition
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Recruiting
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Diabetes Mellitus, Type 2, Nutrition Poor
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
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.
Heather Keller, PhD principal investigator
University of Waterloo
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by University of Waterloo.
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 1 inclusion and 1 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Malnutrition (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800291, which also lists 4 linked publications.
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 5 Feb 2019.