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Feasibility Clinical Study of NLA Tool-US (NLA)

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ClinicalTrials.gov Identifier: NCT01995682
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date November 21, 2013
First Posted Date November 26, 2013
Last Update Posted Date August 7, 2014
Study Start Date December 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2013)
NLA feasibility [ Time Frame: One day ]
Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 21, 2013)
Evaluate the average time required for completing the NLA [ Time Frame: One day ]
Measure the time required to complete the NLA.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasibility Clinical Study of NLA Tool-US
Official Title Evaluate the Feasibility of the NLA Tool, a Combined Assessment of Nutritional and Physical Functional Status, to Provide Personalized Advice for the Independence and Mobility of Elderly
Brief Summary The study is to evaluate the feasibility of the NLA tool, a combined assessment of nutritional and physical functional status, to provide personalized advice for the independence and mobility of elderly.
Detailed Description
  • Determining the proportion of elderly subjects who, according to the NLA result, would qualify for a personalized program to improve their nutritional and physical status;
  • Determining the segmentation (defined by cut-off criteria) of these elderly subjects stratified into 3 NLA subgroups according to strength and endurance performance (33% +/- 10% of target group)
Study Type Observational
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
No biospecimens are to be collected or retained.
Sampling Method Probability Sample
Study Population Independently living men and women at 65-90 years old who are able to walk with or without walking aid
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 6, 2014)
154
Original Estimated Enrollment
 (submitted: November 21, 2013)
250
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. aged between 65 and 90 years,
  2. able to walk with or without walking aid,
  3. having obtained the subject's written informed consent
  4. free of cognitive impairment (3MSE),

Exclusion Criteria:

  1. self reported restriction to exercise(by a physician or other).
  2. unable to carry out performance tests and questionnaires correctly,
  3. self reported lower or upper extremity surgery or fracture in the last 3 months
  4. self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
  5. self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
  6. uncontrolled hypertension (>150/90 mm Hg)
  7. self reported congestive heart failure
  8. unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01995682
Other Study ID Numbers 12.34.NRC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nestlé
Study Sponsor Nestlé
Collaborators Not Provided
Investigators
Principal Investigator: Roger A Fielding, Ph.D. Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
PRS Account Nestlé
Verification Date August 2014