Making the Most of Mealtimes Determinants of Food Intake | NCT02800291

Studies
Making the Most of Mealtimes Determinants of Food Intake

NCT02800291

Sponsor

University of Waterloo

Status

Completed

Last Update Posted

Feb 5, 2019Actual

Enrollment

640Actual

Phase

Not provided

Conditions

Malnutrition

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jun 7, 2016

First Submission Date that Met QC Criteria

Jun 9, 2016

First Posted Date

Jun 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heather Keller, Research Chair, Nutrition & Aging, University of WaterlooPrincipal Investigator

Lead Sponsor

University of WaterlooOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
University of Alberta	OTHER
University of Manitoba	OTHER
Universite de Moncton

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

640Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Malnutrition	Subjective Global Assessment	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

medically stable living in selected units, residing in home for more than one month consent to participate

Exclusion Criteria:

considered end of life by staff; tube feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Heather Keller, PhD	University of Waterloo	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32153857	Derived	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.
30724101	Derived

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases