NCT03871582

Brief Summary

The objective of this study was to analyze if the number of meals with adequate protein intake is associated with functionality in middle to older aged mexican adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

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

Click on a node to explore related trials.

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
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 9, 2019

Last Update Submit

March 19, 2019

Conditions

Keywords

Protein intakeOlder adultsMexican adultsFunctionality

Outcome Measures

Primary Outcomes (2)

  • Functionality on Instrumental Activities of Daily Living - Lawton questionnaire

    Functionality score for instrumental activities of daily living (assessed with Lawton questionnaire). This instrument assess how well the subject perform some daily activities involving tools (e.g. handling finances, taking medication, using the telephone). The instrument consists on five items for men and eight for women, and each item is coded for 0 or 1 depending on if subjects are capable to successfully complete the activity. Therefore, the score ranges from 0 to 5 in men and 0 to 8 in women, the higher the score, the more functional the subj

    One day

  • Functionality on Activities of Daily Living - Barthel questionnaire

    Functionality score for activities of daily living (assessed with Barthel questionnaire). This instrument assess how well the subject perform some daily activities (e.g. dressing, using stairs). The instrument consists on ten items for both men and women coded as 0 or multiples of 5 (i.e. 5, 10, 15) depending on if subjects are capable to successfully complete the activity. The score ranges from 0 to 100 for both men and women, the higher the score, the more functional the subject.

    One day

Study Arms (1)

Participants

Middle to older aged (\>50 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

Age50 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Middle to 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 Sport

Study Record Dates

First Submitted

March 9, 2019

First Posted

March 12, 2019

Study Start

January 1, 2017

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

March 21, 2019

Record last verified: 2019-03

Locations