Clinical trial NCT02719626: Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals
Official title: Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Safety
Nutritive Value
Homebound Persons
Frail Elderly
Keywords: senior
nutrition
home delivered meals
food safety
emergency prep
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 740
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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).

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.

Detailed description: 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:

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Food Safety Kitchen Audit Score
timeFrame: Day 1
measure: Nutritional Adequacy Ratio (NAR)
timeFrame: Day 1
Secondary outcomes:
measure: Nutritional Quality Score (QS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: CareLink
state: Arkansas
city: Los Angeles
country: United States
facility: St. Vincent's Meals on Wheels
state: California
city: Cedar Rapids
country: United States
facility: The Heritage Agency on Aging
state: Iowa
city: Linden
country: United States
facility: Linden Meals on Wheels
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
city: Greenville
country: United States
facility: Greenville Meals on Wheels
state: South Carolina
city: Arlington
country: United States
facility: Meals on Wheels America
state: Virginia
Study officials:
affiliation: Department of Human Ecology, Rutgers the State University of New Jersey
name: William K Hallman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition, Rutgers the State University of New Jersey
name: Carol Byrd-Bredbenner, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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