NCT02719626

Brief Summary

Rutgers University will partner with the Meals on Wheels America (MOWA) and affiliated agencies in five states to conduct a study designed to improve food safety nutrition and emergency preparedness among homebound elderly recipients of home delivered meals (HDM). This population is at increased risk for food borne diseases, as a result of unique physiological and behavioral factors, and is particularly vulnerable to any disruptions in the food system because of their lack of mobility. A multi-method research approach will be used with a target sample of 1,000 MOWA homebound elderly clients. Methods include the use of a novel UPC scanning technology that quickly and comprehensively catalogues all of the food in the clients' homes, a home food safety audit, and a face-to-face interview. The goal of the study is to provide an improved understanding of the unique food safety threats to this at-risk population, suggest easy, cost-effective ways of reducing known food safety risk factors, and provide clear guidelines about the amount and types of food most needed by this population in emergency situations. Dissemination of research findings and recommendations will be done through a partnership with EDEN and MOWA, both of which have national constituencies poised to act on the recommendations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

7 active sites

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

Study Start

First participant enrolled

April 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

February 3, 2016

Last Update Submit

March 21, 2016

Conditions

Keywords

seniornutritionhome delivered mealsfood safetyemergency prep

Outcome Measures

Primary Outcomes (2)

  • Food Safety Kitchen Audit Score

    A 7-scale home food safety kitchen audit score was calculated by summing the affirmative responses to the audit questions was calculated for each household. Items on each scale ranged from 3-12 for total score of 0 to 43 and all were weighted equally.

    Day 1

  • Nutritional Adequacy Ratio (NAR)

    A household Nutrition Adequacy Ratio was calculated by summing nutrition values based on the daily values for a 2,000kcal diet for each food. NARs are ratios where 1 is recommended, \>1 is more than recommended and \<1 is inadequate.

    Day 1

Secondary Outcomes (1)

  • Nutritional Quality Score (QS)

    Day 1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Home delivered meal recipients for at least 6 months, who: live alone, are 60 or more years old, have no overt cognitive impairment, and are from 5 states (AR, CA, IA, NJ \& SC; one site per state).

You may qualify if:

  • or more years old
  • live alone
  • no overt cognitive impairment
  • receiving home delivered meals for at least 6 months prior to the in-home visit

You may not qualify if:

  • \< 60 years old
  • do not live alone
  • overt cognitive impairment
  • receiving home delivered meals for less than 6 months prior to the in-home visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CareLink

Little Rock, Arkansas, 72119-5988, United States

Location

St. Vincent's Meals on Wheels

Los Angeles, California, 90057, United States

Location

The Heritage Agency on Aging

Cedar Rapids, Iowa, 52404, United States

Location

Linden Meals on Wheels

Linden, New Jersey, 07036, United States

Location

Rutgers University

New Brunswick, New Jersey, 08902, United States

Location

Greenville Meals on Wheels

Greenville, South Carolina, 29605-1780, United States

Location

Meals on Wheels America

Arlington, Virginia, 22202, United States

Location

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Study Officials

  • William K Hallman, PhD

    Department of Human Ecology, Rutgers the State University of New Jersey

    PRINCIPAL INVESTIGATOR
  • Carol Byrd-Bredbenner, PhD, RD

    Department of Nutrition, Rutgers the State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

March 25, 2016

Study Start

April 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Aggregate results will be made available via website (in process).

Locations