- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04245462
Adequate Protein Intake Per Meal and Physical Disability in Mexican Adults Aged 60 Years and Older
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44430
- Instituto de Ciencias Aplicadas a la Actividad Física y al Deporte
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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).
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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
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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