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

Frail Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719626
• Other study ID #: 10-551Mx
• Secondary ID: USDA NIFSI # 201
• Status: Completed
• Phase: N/A
• First received: February 3, 2016
• Last updated: March 21, 2016
• Start date: April 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2016
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 740
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Food Safety
• Frail Elderly
• Homebound Persons
• Nutritive Value

Locations

Country	Name	City	State
United States	Meals on Wheels America	Arlington	Virginia
United States	The Heritage Agency on Aging	Cedar Rapids	Iowa
United States	Greenville Meals on Wheels	Greenville	South Carolina
United States	Linden Meals on Wheels	Linden	New Jersey
United States	CareLink	Little Rock	Arkansas
United States	St. Vincent's Meals on Wheels	Los Angeles	California
United States	Rutgers University	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

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* Note: There are 108 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Nutritional Quality Score (QS)	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.	Day 1	No