Food SafetyNCT02719626
Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals
An observational study of Food Safety and Nutritive Value, run by Rutgers, The State University of New Jersey at 7 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Food Safety, Nutritive Value, Homebound Persons
- How many people
- 740 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- < 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Meals on Wheels America
Arlington, Virginia, 22202
The Heritage Agency on Aging
Cedar Rapids, Iowa, 52404
Greenville Meals on Wheels
Greenville, South Carolina, 29605-1780
Linden Meals on Wheels
Linden, New Jersey, 07036
CareLink
Little Rock, Arkansas, 72119-5988
St. Vincent's Meals on Wheels
Los Angeles, California, 90057
Rutgers University
New Brunswick, New Jersey, 08902
About this study
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.
Read the 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:
- 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.
- Conditions
- Food Safety, Nutritive Value, Homebound Persons, Frail Elderly
- Keywords
- senior, nutrition, home delivered meals, food safety, emergency prep
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startApr 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (108)Papers the sponsor has linked to this study.
- Other trials for Food SafetyStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William K Hallman, PhD, Principal investigator, Department of Human Ecology, Rutgers the State University of New JerseyCarol Byrd-Bredbenner, PhD, RD, Principal investigator, Department of Nutrition, Rutgers the State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719626
- Sponsor's protocol ID
- 10-551Mx
- Other IDs
- USDA NIFSI # 2010-51110-21078
- Status last verified
- Feb 2016
- First submitted
- 3 Feb 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate results will be made available via website (in process).
Publications
Albertson AM, Wold AC, Joshi N. Ready-to-Eat Cereal Consumption Patterns: The Relationship to Nutrient Intake, Whole Grain Intake, and Body Mass Index in an Older American Population. J Aging Res. 2012;2012:631310. doi: 10.1155/2012/631310. Epub 2012 Oct 10.
PubMed 23094158Aldrich N, Benson WF. Disaster preparedness and the chronic disease needs of vulnerable older adults. Prev Chronic Dis. 2008 Jan;5(1):A27. Epub 2007 Dec 15.
PubMed 18082016Anderson AL, Verrill LA, Sahyoun NR. Food safety perceptions and practices of older adults. Public Health Rep. 2011 Mar-Apr;126(2):220-7. doi: 10.1177/003335491112600213.
PubMed 21387952Almanza BA, Namkung Y, Ismail JA, Nelson DC. Clients' safe food-handling knowledge and risk behavior in a home-delivered meal program. J Am Diet Assoc. 2007 May;107(5):816-21. doi: 10.1016/j.jada.2007.02.043.
PubMed 17467379Altshuler, N & Schimmel, J. USDHHS, Administration on Aging. Aging in Place: Do Older Americans Act Title III Services Reach Those Most Likely to Enter Nursing Homes? Research Brief Number 1, 2010. Available at: http://www.aoa.gov/aoaroot/program_results/docs/2010/AoA1_NursingHomes_012011.pdf Accessed on 06/23/14.
Barile JP, Thompson WW, Zack MM, Krahn GL, Horner-Johnson W, Bowen SE. Multiple chronic medical conditions and health-related quality of life in older adults, 2004-2006. Prev Chronic Dis. 2013 Sep 26;10:E162. doi: 10.5888/pcd10.120282.
PubMed 24070034Barrett, A & Schimmel, J. USDHHS, Administration on Aging. OAA Title III Services Target the Most Vulnerable Elderly in the United States. Research Brief Number 2, 2010. Available at: http://www.aoa.gov/Program_Results/docs/2010/AoA_2_HealthStatus_041311.pdf Accessed on 06/23/2014.
Blackburn ML, Bruhn CM, Miller LS, Ganthavorn C, Ober BA. Seniors, and their food handlers and caregivers, need food safety and nutrition education. Calif Agric. 2014;68(1):30-37. DOI: 10.3733/ca.v068n01p30.
Bouillon K, Kivimaki M, Hamer M, Shipley MJ, Akbaraly TN, Tabak A, Singh-Manoux A, Batty GD. Diabetes risk factors, diabetes risk algorithms, and the prediction of future frailty: the Whitehall II prospective cohort study. J Am Med Dir Assoc. 2013 Nov;14(11):851.e1-6. doi: 10.1016/j.jamda.2013.08.016. Epub 2013 Oct 6.
PubMed 24103860Buzby JC. Older adults at risk of complications from microbial foodborne illness. Food Review. 2002;25(2):30-35.
Byrd-Bredbenner C, Maurer J, Wheatley V, Cottone E, Clancy M. Food safety hazards lurk in the kitchens of young adults. J Food Prot. 2007 Apr;70(4):991-6. doi: 10.4315/0362-028x-70.4.991.
PubMed 17477272Byrd-Bredbenner C, Abbot JM, Cussler E. Nutrient profile of household food supplies of families with young children. J Am Diet Assoc. 2009 Dec;109(12):2057-62. doi: 10.1016/j.jada.2009.09.006.
PubMed 19942024Byrd-Bredbenner C, Schaffner DW, Maurer Abbot J. How food safe is your home kitchen? A self-directed home kitchen audit. J Nutr Educ Behav. 2010 Jul-Aug;42(4):286-9. doi: 10.1016/j.jneb.2010.01.008. No abstract available.
PubMed 20579613Cates SC, Kosa KM, Karns S, Godwin SL, Speller-Henderson L, Harrison R, Ann Draughon F. Food Safety Knowledge and Practices among Older Adults: Identifying Causes and Solutions for Risky Behaviors. J Nutr Elder. 2009 Apr;28(2):112-26. doi: 10.1080/01639360902949986.
PubMed 21184361Champion V & Skinner C. The Health Belief Model. In: Glanz K, Rimer B, Viswanath K, eds. Health behavior and health education: theory, research, and practice, 4th Ed. San Francisco: Jossey-Bass, 2008:45-66.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving The Safety And Nutritional Adequacy Of The Home Food Supply Of Elderly Recipients Of Home Delivered Meals
- ClinicalTrials.gov ID
- NCT02719626
- Acronym / sponsor ID
- 10-551Mx
- Conditions
- Food Safety, Nutritive Value, Homebound Persons, Frail Elderly
- Keywords
- senior, nutrition, home delivered meals, food safety, emergency prep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Nutritional Quality Score (QS)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Background: PubMed 23094158Albertson AM, Wold AC, Joshi N. Ready-to-Eat Cereal Consumption Patterns: The Relationship to Nutrient Intake, Whole Grain Intake, and Body Mass Index in an Older American Population. J Aging Res. 2012;2012:631310. doi: 10.1155/2012/631310. Epub 2012 Oct 10.
- Background: PubMed 18082016Aldrich N, Benson WF. Disaster preparedness and the chronic disease needs of vulnerable older adults. Prev Chronic Dis. 2008 Jan;5(1):A27. Epub 2007 Dec 15.
- Background: PubMed 21387952Anderson AL, Verrill LA, Sahyoun NR. Food safety perceptions and practices of older adults. Public Health Rep. 2011 Mar-Apr;126(2):220-7. doi: 10.1177/003335491112600213.
- Background: PubMed 17467379Almanza BA, Namkung Y, Ismail JA, Nelson DC. Clients' safe food-handling knowledge and risk behavior in a home-delivered meal program. J Am Diet Assoc. 2007 May;107(5):816-21. doi: 10.1016/j.jada.2007.02.043.
- BackgroundAltshuler, N & Schimmel, J. USDHHS, Administration on Aging. Aging in Place: Do Older Americans Act Title III Services Reach Those Most Likely to Enter Nursing Homes? Research Brief Number 1, 2010. Available at: http://www.aoa.gov/aoaroot/program_results/docs/2010/AoA1_NursingHomes_012011.pdf Accessed on 06/23/14.
- Background: PubMed 24070034Barile JP, Thompson WW, Zack MM, Krahn GL, Horner-Johnson W, Bowen SE. Multiple chronic medical conditions and health-related quality of life in older adults, 2004-2006. Prev Chronic Dis. 2013 Sep 26;10:E162. doi: 10.5888/pcd10.120282.
- BackgroundBarrett, A & Schimmel, J. USDHHS, Administration on Aging. OAA Title III Services Target the Most Vulnerable Elderly in the United States. Research Brief Number 2, 2010. Available at: http://www.aoa.gov/Program_Results/docs/2010/AoA_2_HealthStatus_041311.pdf Accessed on 06/23/2014.
- BackgroundBlackburn ML, Bruhn CM, Miller LS, Ganthavorn C, Ober BA. Seniors, and their food handlers and caregivers, need food safety and nutrition education. Calif Agric. 2014;68(1):30-37. DOI: 10.3733/ca.v068n01p30.
- Background: PubMed 24103860Bouillon K, Kivimaki M, Hamer M, Shipley MJ, Akbaraly TN, Tabak A, Singh-Manoux A, Batty GD. Diabetes risk factors, diabetes risk algorithms, and the prediction of future frailty: the Whitehall II prospective cohort study. J Am Med Dir Assoc. 2013 Nov;14(11):851.e1-6. doi: 10.1016/j.jamda.2013.08.016. Epub 2013 Oct 6.
- BackgroundBuzby JC. Older adults at risk of complications from microbial foodborne illness. Food Review. 2002;25(2):30-35.
- Background: PubMed 17477272Byrd-Bredbenner C, Maurer J, Wheatley V, Cottone E, Clancy M. Food safety hazards lurk in the kitchens of young adults. J Food Prot. 2007 Apr;70(4):991-6. doi: 10.4315/0362-028x-70.4.991.
- Background: PubMed 19942024Byrd-Bredbenner C, Abbot JM, Cussler E. Nutrient profile of household food supplies of families with young children. J Am Diet Assoc. 2009 Dec;109(12):2057-62. doi: 10.1016/j.jada.2009.09.006.
- Individual participant dataSharing planned: No. Aggregate results will be made available via website (in process).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Hallman, PhD principal investigator
Department of Human Ecology, Rutgers the State University of New Jersey
Carol Byrd-Bredbenner, PhD, RD principal investigator
Department of Nutrition, Rutgers the State University of New Jersey
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Safety and Nutritive Value, run by Rutgers, The State University of New Jersey at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Safety Kitchen Audit Score (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02719626, which also lists 108 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2016.