Adequate Protein Intake Per Meal and Physical Disability in Mexican Adults Aged 60 Years and Older

January 27, 2020 updated by: Juan Ricardo Lopez y Taylor, Centro Universitario de Ciencias de la Salud, Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Detailed dietary information was obtained for each participant to estimate dietary protein intake per meal (breakfast, lunch, dinner). One meal was considered with adequate protein content if it contained >30 g or >0.4 g/kg. Then, the number of meals with an adequate protein content was counted and classified as Zero meals, One meal, or Two or Three meals.

Physical disability was assessed with two validated questionnaires. One for instrumental activities of daily living (Lawton) and another for activities of daily living (Barthel). Disability was classified for each questionnaire item according to the authors' scales. Most items considered a physical disability if the participant reported any difficulty performing that task.

To analyze the association between the number of meals with adequate protein content (predictive variable) and physical disability (outcome variable), we used binomial logistic regression for each item. For the number of meals, we set the group of Zero meals as the reference. The analyses were adjusted for age, BMI categories, number of diagnosed diseases, sex, and inadequate protein intake per day (<1.2 g/kg/d).

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44430
        • Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants
Older aged (>60 years) Mexican adults attending to the Geriatrics Department from the Western General Hospital (Zapopan, Jalisco, Mexico).
Cross-sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability on Instrumental Activities of Daily Living
Time Frame: One day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability on Activities of Daily Living
Time Frame: One day
Disability reported for each item of activities of daily living (assessed with Barthel questionnaire). This instrument assesses how well the subject performs some daily activities (e.g. dressing, using stairs). The instrument consists of 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. When the subject performs the activity without difficulty (the highest score) he/she is deemed as functional, and any other difficulty as a disability.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

July 1, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

January 27, 2020

First Posted (ACTUAL)

January 29, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • HGO-ICAAFYD18-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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