NCT04245462

Brief Summary

This study sought to determine if the number of meals per day with an adequate protein content (defined as eating \>30 g protein or \>0.4 g protein/kg body mass each) is associated with presenting physical disability in Mexican adults aged 60 years and older. Physical disability was evaluated with self-reported questionnaires for different activities of daily living.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

January 27, 2020

Last Update Submit

January 27, 2020

Conditions

Keywords

Protein intakeOlder adultsPhysical disabilityMexican adults

Outcome Measures

Primary Outcomes (1)

  • Disability on Instrumental Activities of Daily Living

    Disability reported for each item of instrumental activities of daily living (assessed with Lawton questionnaire). This instrument assesses how well the subject performs some daily activities involving tools (e.g. handling finances, taking medication, using the telephone). The instrument consists of five items for men and eight for women, and each item is coded for 0 (disabled) or 1 (functional) depending on if subjects are capable to successfully complete the activity. We only used the five items that apply for both men and women.

    One day

Secondary Outcomes (1)

  • Disability on Activities of Daily Living

    One day

Study Arms (1)

Participants

Older aged (\>60 years) Mexican adults attending to the Geriatrics Department from the Western General Hospital (Zapopan, Jalisco, Mexico).

Other: No intervention

Interventions

Cross-sectional

Participants

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older aged Mexican adults attending to the Geriatrics Department at the Western General Hospital (Hospital General de Occidente) for their usual medical screening or first-time assessment.

You may qualify if:

  • Subjects able to stand up and walk independently or with walking sticks only.
  • Subjects able to answer questionnaires independently or with minimum caregivers' assistance.

You may not qualify if:

  • Subjects reporting any kind of hospitalization within the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte

Guadalajara, Jalisco, 44430, Mexico

Location

Study Officials

  • Alejandro Gaytán-González

    University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Institute of Applied Sciences for Physical Activity and Spor

Study Record Dates

First Submitted

January 27, 2020

First Posted

January 29, 2020

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

January 29, 2020

Record last verified: 2020-01

Locations