NCT04042987

Brief Summary

This study aims to assess the malnutrition prevalence of Colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused QIP implemented in a Colombian ambulatory care facility on healthcare utilization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

July 30, 2019

Last Update Submit

October 1, 2020

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Malnutrition

    Measured by the Mini Nutritional Assessment (MNA®) a maximum 30 point scale resulting in a single Malnutrition Indicator Score where lower number indicates malnutrition

    Change from Baseline to Week 10 post-QIP enrollment

Secondary Outcomes (1)

  • Healthcare Resource Utilization

    10-weeks follow-up period post enrollment from ambulatory care facility

Other Outcomes (6)

  • Body mass index (BMI)

    Baseline and Week 10 post-QIP enrollment

  • Calf Circumference (CC)

    Baseline and Week 10 post-QIP enrollment

  • Short Physical Performance Battery (SPPB)

    Baseline and Week 10 post-QIP enrollment

  • +3 more other outcomes

Study Arms (2)

Historical Control Group

Retrospective chart review

Prospective QIP Group

Participants that meet eligibility criteria will be prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sites will recruit patients for QIP group at discharge from hospital (after 3 months) or in ambulatory care facility.

You may qualify if:

  • Patient is screened as being malnourished or at risk for malnutrition
  • Patient can consumer beverages and food orally
  • Patients have a life expectancy of equal or greater than 90 days
  • Patient is literate and willing to voluntarily sign and date an Informed Consent Form (ICF) after it is explained

You may not qualify if:

  • Patient is pregnant
  • Patient is intubated, receiving tube feeding or parenteral nutrition
  • Patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with QIP study requirements and help with the completion of QIP study materials
  • Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures
  • Patient has an allergy or intolerance to any of the ONS ingredients
  • Patients does not want to participate or sign ICF
  • Patient is bedridden or confined in a wheelchair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatric Unit. Hospital Universitario San Ignacio, Aging Institute, Pontificia Universidad Javeriana

Bogotá, Colombia

Location

Related Publications (2)

  • Gomez G, Botero-Rodriguez F, Misas JD, Garcia-Cifuentes E, Sulo S, Brunton C, Venegas-Sanabria LC, Gracia DA, Cano Gutierrez CA. A nutritionally focused program for community-living older adults resulted in improved health and well-being. Clin Nutr. 2022 Jul;41(7):1549-1556. doi: 10.1016/j.clnu.2022.05.003. Epub 2022 May 13.

    PMID: 35667271DERIVED

  • Chavarro-Carvajal DA, Ayala AM, Venegas-Sanabria LC, Gomez G, Sulo S, Misas JD, Cano-Gutierrez C. Use of a nutrition-focused quality improvement program for community-living older adults at malnutrition risk is associated with better nutritional outcomes. Clin Nutr ESPEN. 2022 Apr;48:291-297. doi: 10.1016/j.clnesp.2022.01.032. Epub 2022 Feb 2.

    PMID: 35331504DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Suela Sulo, PhD, MSc

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 2, 2019

Study Start

September 10, 2019

Primary Completion

March 19, 2020

Study Completion

June 12, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

CO(1)