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Completed

NCT Number: NCT02719626

Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CareLink, Little Rock, Arkansas, United States

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About this study

Elderly homebound recipients of home delivered meals (HDM) are at increased risk for foodborne disease and particularly vulnerable to disruptions that might prevent the delivery or safe consumption of food. In addition, there is a great deal of variability in the cognitive and physical abilities of those within this population, as well as a range of access to financial resources and social support that may vary both individually and geographically. Moreover, the agencies serving this population depend heavily on the time and donations of volunteers to carry out their important work. Therefore, to ensure their implementation, interventions designed to address food safety issues within this population must be relatively simple, efficient, and cost effective.

To address these issues, a multi-method research approach will be used, incorporating Universal Product Code (UPC) scanning technology combined with a dynamically growing database of foods and their associated nutritional parameters to catalogue the in-home food supply, an extant home food safety audit form, modified for study use, and a computer-enhanced questionnaire administered during an in-home interview. This project will provide a useful understanding of the nutritional and food safety gaps in this at-risk population that will allow for the design and testing of interventions to improve the food safety of both the HDM and the in-home food available to the homebound elderly. It will also provide clear and useful guidelines about the amount and types of food most needed by this population in emergency situations. Dissemination of the resulting research findings and recommendations will be accomplished through a partnership with the Extension Disaster Education Network (EDEN) and MOWA, both of whom have national constituencies poised to act on the recommendations.

HDM agencies from 5 states (AR, CA, IA, NJ, SC) will be purposively selected because of the varied characteristics of their HDM clients, as identified in an analysis of HDM recipients by state. The purposive sample of states included at least one from each of four of the quintiles on the MOWA Senior Hunger state ranking, with two states from the top quintile. The chosen states also represented a range in terms of the percentage minority clients, with some high in minority population and one extremely low. Finally, the percentage of rural clients ranged from zero in one state to almost 70% in another. Each of the five agencies will be asked to complete the study protocol with 200 eligible HDM recipients drawn from those on their client rolls using random numbers generated by the study investigators. Sampling with replacement will be carried out until a quota of 200 participants is reached, or no additional eligible clients can be recruited within each agency. A targeted sample size of 200 participants for each agency was selected to provide an overall target sample of 1000 HDM recipients to yield an overall sampling error rate of ± 3.1%, based on a population of approximately 900,000 HDM recipients.

The study:

  • Will analyze the food safety and quality parameters of the home food environments of homebound elderly recipients of HDM, and identify specific barriers to safe food-handling and storage practices by members of this high risk population. Refrigerator/freezer temperatures will be taken and adjustment made as needed to ensure that refrigerated foods are stored below 40 °F and frozen foods below 0 °F.
  • Will estimate the nutrient density and adequacy of the home food supplies of homebound elderly recipients of HDM, and identify areas of nutrition in which this population is deficient and would benefit from specific supplemental nutrition, especially during emergencies.
  • Two interventions will be proposed to improve food safety in homebound elderly recipients of HDM: the implementation of dating labels on the meals to help prevent the consumption of potentially unsafe older foods; checking refrigerator/freezer temperatures to determine temperature adherence/ maintenance, with adjustment made as needed.
  • Will partner with nutritionists, emergency preparedness experts, MOWA, and the Extension Disaster Education Network (EDEN) to develop and disseminate food safety and emergency preparedness recommendations specifically tailored to the needs of the homebound elderly. Materials will be developed for emergency food providers, home delivery meal providers and the elderly themselves.

Rutgers will partner with the Meals on Wheels America (MOWA) and selected MOWA affiliated agencies in five states to conduct an in-depth study of this vulnerable population designed to improve the nutrition and safety of food consumed by homebound elderly recipients of HDM, and to strengthen the nation's food defense system by identifying and addressing the critical nutrition needs of this population, particularly during times of emergency.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 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

Exclusion criteria

  • < 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

Treatment and study plan

Primary outcomes

  1. Food Safety Kitchen Audit Score

    Time frame: Day 1

    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.

  2. Nutritional Adequacy Ratio (NAR)

    Time frame: Day 1

    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.

Secondary outcomes

  1. Nutritional Quality Score (QS)

    Time frame: Day 1

    A household summary nutrition quality score was calculated by summing up the NARs for 6 recommended nutrients and dividing the result by the NARs for the non-recommended nutrients in the home food supply for each household.

    Quality Score is a ratio where 1 is recommended, >1 is more than recommended and <1 is inadequate.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 25, 2016
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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