Respiratory Tract InfectionsSTUFFYNCT00448981
Stopping Upper Respiratory Infections and Flu in the Family: The Stuffy Trial
A study testing Education, Hand Sanitizer and Face Masks in people with Respiratory Tract Infections and Common Cold, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Common Cold
- What is being tested?
- Education, Hand Sanitizer and Face Masks
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,788 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Jun 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Households with at least three members
- At least one preschool or elementary school-aged child in the household
- Residence in Northern Manhattan
- Ability to speak English or Spanish
- Access to a telephone
- Willingness to participate in regular symptom reporting and home visits
- Not routinely using alcohol-based hand sanitizer at baseline
Who cannot join
- Households with fewer than three members
- No preschool or elementary school-aged child in the household
- Inability to communicate in English or Spanish
- No access to a telephone
- Unwillingness or inability to comply with study procedures
- Routine use of alcohol-based hand sanitizer prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University School of Nursing
New York, New York, 10032
About this study
Official title: Stopping URIs and Flu in the Family: The Stuffy Trial
Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan and each household will be randomly assigned to one of these three groups. We will then follow these households for 15 months to see how often they get cold and flu symptoms. We will also look at antibiotic use practices for symptoms of colds and influenza ; household member knowledge of prevention and treatment strategies for pandemic influenza and viral URIs; and rates of influenza vaccination among household members. When someone in the study has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a nasal culture (by swabbing the nose) to see if there is flu virus present.
Read the detailed description
Although 'colds' and seasonal influenza are clinically very different diseases from pandemic influenza, they share common transmission pathways and the community level interventions needed to reduce both seasonal flu, common viral upper respiratory infections and pandemic influenza are likely to be similar.
Aims of this project are to compare the impact of two household level interventions (an alcohol based hand sanitizer with or without face masks) on six outcomes: incidence and strains of virologically confirmed influenza in study households; rates of symptoms; number of secondary cases in households; antibiotic use practices for symptoms of influenza and other viral upper respiratory infections; household member knowledge of prevention and treatment strategies for pandemic influenza and viral upper respiratory infections; and rates of influenza vaccination among household members.
450 households in northern Manhattan (primarily recently immigrated Hispanics) will be randomized to three groups: control (receiving only a pamphlet on influenza prevention), alcohol hand sanitizer, and sanitizer plus face masks. Symptoms of influenza will be monitored daily for 15 months using ecological momentary assessment technology. Virologic cultures will be obtained from persons with flu symptoms (fever >100 degrees F., sore throat and/or cough). Antibiotic use practices, knowledge, and vaccination rates will be assessed by survey using piloted, psychometrically sound instruments. For this cluster randomization design with randomized intervention on the household level, outcomes will be measured at the individual and household level using generalized linear mixed model for counts response with a Poisson distribution and other appropriate multivariate techniques to control for confounding.
Comparison(s): The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: comparison of transmission in groups receiving educational material only to a group receiving educational material and instructed to use alcohol hand sanitizers to a group receiving educational material and instructed to use alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu
- Conditions
- Respiratory Tract Infections, Common Cold
- Being tested
- Education, Hand Sanitizer, Face Masks
- Keywords
- Preventing upper respiratory tract infections, Preventing influenza, Preventing the common cold, Hand hygiene and upper respiratory infections, Mask use in preventing upper respiratory infections
- Medical subject headings
- Respiratory Tract Infections, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza.
Hand SanitizerDevice
Alcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school.
Face MasksDevice
Surgical face masks with instructions for use when a household member develops influenza-like illness (ILI).
| Study group | Role | What they receive |
|---|---|---|
| Education (Control Group) | Other | Participants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza. Receives: Behavioral: Education |
| Education + Hand Sanitizer | Other | Participants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school. Receives: Behavioral: Education; Device: Hand Sanitizer |
| Education + Hand Sanitizer + Face Masks | Other | Participants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI). Receives: Behavioral: Education; Device: Hand Sanitizer; Device: Face Masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of virologically confirmed influenza and influenza vaccination
Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report.
Measured: Throughout 19-month follow-up period
Rates of influenza-like symptoms
Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat).
Measured: Throughout 19-month follow-up period (symptoms reported at least twice weekly)
Knowledge and attitudes about influenza and the common cold and antibiotic use practices.
Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment.
Measured: Baseline and end of study (up to 19 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startNov 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,788 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elaine Larson, RN,PhD, Principal investigator, Columbia University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448981
- Sponsor's protocol ID
- CDC-NCEZID-5033
- Other IDs
- 1U01CI000442-01
- Acronym
- STUFFY
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2007
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen B, Ferng YH, Wong-McLoughlin J, Jia H, Morse SS, Larson EL. Predictors of flu vaccination among urban Hispanic children and adults. J Epidemiol Community Health. 2012 Mar;66(3):204-9. doi: 10.1136/jech.2009.099879. Epub 2010 Sep 29.
PubMed 20881023
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stopping URIs and Flu in the Family: The Stuffy Trial
- ClinicalTrials.gov ID
- NCT00448981
- Acronym / sponsor ID
- STUFFY / CDC-NCEZID-5033
- Conditions
- Respiratory Tract Infections, Common Cold
- Keywords
- Preventing upper respiratory tract infections, Preventing influenza, Preventing the common cold, Hand hygiene and upper respiratory infections, Mask use in preventing upper respiratory infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,788 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Nov 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Mar 2007 (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.
Colds and flu cause much loss of work and school. The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: some educational material, educational material and use of alcohol hand sanitizers, and educational material and use of alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu. We will recruit 450 households in Northern Manhattan and each household will be randomly assigned to one of these three groups. We will then follow these households for 15 months to see how often they get cold and flu symptoms. We will also look at antibiotic use practices for symptoms of colds and influenza ; household member knowledge of prevention and treatment strategies for pandemic influenza and viral URIs; and rates of influenza vaccination among household members. When someone in the study has serious flu symptoms such as a high fever and cough or sore throat, we will also obtain a nasal culture (by swabbing the nose) to see if there is flu virus present.
Detailed description
Although 'colds' and seasonal influenza are clinically very different diseases from pandemic influenza, they share common transmission pathways and the community level interventions needed to reduce both seasonal flu, common viral upper respiratory infections and pandemic influenza are likely to be similar.
Aims of this project are to compare the impact of two household level interventions (an alcohol based hand sanitizer with or without face masks) on six outcomes: incidence and strains of virologically confirmed influenza in study households; rates of symptoms; number of secondary cases in households; antibiotic use practices for symptoms of influenza and other viral upper respiratory infections; household member knowledge of prevention and treatment strategies for pandemic influenza and viral upper respiratory infections; and rates of influenza vaccination among household members.
450 households in northern Manhattan (primarily recently immigrated Hispanics) will be randomized to three groups: control (receiving only a pamphlet on influenza prevention), alcohol hand sanitizer, and sanitizer plus face masks. Symptoms of influenza will be monitored daily for 15 months using ecological momentary assessment technology. Virologic cultures will be obtained from persons with flu symptoms (fever >100 degrees F., sore throat and/or cough). Antibiotic use practices, knowledge, and vaccination rates will be assessed by survey using piloted, psychometrically sound instruments. For this cluster randomization design with randomized intervention on the household level, outcomes will be measured at the individual and household level using generalized linear mixed model for counts response with a Poisson distribution and other appropriate multivariate techniques to control for confounding.
Comparison(s): The purpose of this study is to try to reduce the transmission of colds and flu among household members with one of three interventions: comparison of transmission in groups receiving educational material only to a group receiving educational material and instructed to use alcohol hand sanitizers to a group receiving educational material and instructed to use alcohol hand sanitizers as well as face masks when somebody has symptoms of the flu
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education (Control Group) | Other | Behavioral: EducationParticipants received written educational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza. |
| Education + Hand Sanitizer | Other | Behavioral: Education, Device: Hand SanitizerParticipants received the same educational materials plus alcohol-based hand sanitizer (multiple sizes) for use at home, work, and school. |
| Education + Hand Sanitizer + Face Masks | Other | Behavioral: Education, Device: Hand Sanitizer, Device: Face MasksParticipants received educational materials, hand sanitizer, and surgical face masks with instructions for use when a household member developed influenza-like illness (ILI). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Households with at least three members
- At least one preschool or elementary school-aged child in the household
- Residence in Northern Manhattan
- Ability to speak English or Spanish
- Access to a telephone
Key exclusion criteria (6 listed)
- Households with fewer than three members
- No preschool or elementary school-aged child in the household
- Inability to communicate in English or Spanish
- No access to a telephone
- Unwillingness or inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducational materials (English or Spanish) on prevention and treatment of upper respiratory infections (URIs) and influenza. | Behavioural | Education (Control Group), Education + Hand Sanitizer, Education + Hand Sanitizer + Face Masks |
| Hand SanitizerAlcohol-based hand sanitizer provided in multiple sizes for use at home, work, and school. | Device | Education + Hand Sanitizer, Education + Hand Sanitizer + Face Masks |
| Face MasksSurgical face masks with instructions for use when a household member develops influenza-like illness (ILI). | Device | Education + Hand Sanitizer + Face Masks |
Primary outcome
Rates of virologically confirmed influenza and influenza vaccination
Time frame: Throughout 19-month follow-up period
Incidence of laboratory-confirmed influenza based on nasal swab specimens analyzed by viral culture or PCR; vaccination rates assessed via participant report.
Rates of influenza-like symptoms
Time frame: Throughout 19-month follow-up period (symptoms reported at least twice weekly)
Incidence of ILI episodes defined using CDC criteria (fever ≥37.8°C with cough and/or sore throat).
Knowledge and attitudes about influenza and the common cold and antibiotic use practices.
Time frame: Baseline and end of study (up to 19 months)
Change in knowledge, attitudes, and practices (KAP) score based on a 10-item survey assessing understanding of transmission, prevention, and treatment.
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 5 May 2026.
- Derived from this study: PubMed 20881023Cohen B, Ferng YH, Wong-McLoughlin J, Jia H, Morse SS, Larson EL. Predictors of flu vaccination among urban Hispanic children and adults. J Epidemiol Community Health. 2012 Mar;66(3):204-9. doi: 10.1136/jech.2009.099879. Epub 2010 Sep 29.
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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.
Elaine Larson, RN,PhD principal investigator
Columbia University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Hand Sanitizer and Face Masks in people with Respiratory Tract Infections and Common Cold, run by Centers for Disease Control and Prevention at 1 site 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 7 inclusion and 6 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Rates of virologically confirmed influenza and influenza vaccination (time frame: Throughout 19-month follow-up period). The study lists 3 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 NCT00448981, which also lists 1 linked publication.
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 5 May 2026.