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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04245462
Other study ID # HGO-ICAAFYD18-4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date August 2017

Study information

Verified date January 2020
Source Centro Universitario de Ciencias de la Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 187
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
Cross-sectional

Locations

Country Name City State
Mexico Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte Guadalajara Jalisco

Sponsors (2)

Lead Sponsor Collaborator
Centro Universitario de Ciencias de la Salud, Mexico Hospital General de Occidente

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Disability on Activities of Daily Living 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
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