NCT01995682

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

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

First Submitted

Initial submission to the registry

November 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 7, 2014

Status Verified

August 1, 2014

Enrollment Period

7 months

First QC Date

November 21, 2013

Last Update Submit

August 6, 2014

Conditions

Healthy

Keywords

Independent livingwalk with or without walking aids

Outcome Measures

Primary Outcomes (1)

  • NLA feasibility

    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.

    One day

Secondary Outcomes (1)

  • Evaluate the average time required for completing the NLA

    One day

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Independently living men and women at 65-90 years old who are able to walk with or without walking aid

You may qualify if:

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

You may not qualify if:

  • self reported restriction to exercise(by a physician or other).
  • unable to carry out performance tests and questionnaires correctly,
  • self reported lower or upper extremity surgery or fracture in the last 3 months
  • self-reported symptomatic coronary artery disease, myocardial infarction in last 6 months
  • self reported history of neurological disease (e.g., Parkinson disease, stroke) with residual impairment
  • uncontrolled hypertension (\>150/90 mm Hg)
  • self reported congestive heart failure
  • unable to communicate in English. Non-English speaking individuals will be excluded due to safety concerns in being able to understand testing instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University

Boston, Massachusetts, 02111, United States

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens are to be collected or retained.

Study Officials

  • Roger A Fielding, Ph.D.

    Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 26, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 7, 2014

Record last verified: 2014-08

Locations

US(1)