TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women
Phase: NA
Conditions: Obesity
Sponsor: University of Alabama at Birmingham

1 
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older 
Black Women 
Study Protocol 
NCT:  IRB-300004159 
Date of Last Protocol Approval: 12 November 2019 
Pamela G. Bowen, PhD, CRNP, FNP-BC, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 

 
 
 
 
 
 
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 TOSS Feasibility + Fitbit Community = Reduced Obesity 
in Older Black Women 
 
Principal Investigator: Pamela G. Bowen 
Sponsor: National Institute on Minority Health and Health Disparities 
National Clinical Trial (NCT) Identified Number:  IRB-300004159 
 
Version Number:  v1.0 
12 November 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR). The Principal 
Investigator will assure that no deviation from, or changes to, the protocol will take place without prior 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the local Institutional Review Board (IRB) for review and approval. Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form will be IRB approved; a determination will be made regarding whether a 
new consent needs to be obtained from subjects who provided consent, using a previously approved 
consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black 
Women 
Study Description: 
The proposed obesity-reduction intervention is aligned with Stage 1 of the 
National Institute on Aging Stage Model for Behaviors Interventions 
Development. We propose a 2-group randomized controlled, 12-week 
feasibility study in which 30 older, overweight or obese Black women will 
be randomized to receive either the Texting Older Sisters to Step (TOSS) 
PA Text messages Plus Fitbit community group or the Control group. The 
primary goal of our proposed study is two-fold: 1) to test whether the 
TOSS Plus physical activity (PA) intervention is acceptable and realistic, and 
assess attrition rates among older, overweight or obese Black women and 
2) evaluate the TOSS Plus PA intervention influence to potentially increase 
baseline PA behaviors (number of steps and minutes of daily activity). We 
will explore the relationship between the participant’s self-efficacy, 
methods they use to make changes PA behaviors, peer support, and 
quality of life. We hypothesize that older, overweight or obese Black 
women who participate in the TOSS PA intervention group will show 
increases in PA behaviors compared to the control group. We will also 
investigate the effects of the TOSS PA intervention on cardiometabolic risk 
factors: weight, abdominal obesity [waist circumference], body mass 
index, and glycated hemoglobin; and 2) explore the effects of the TOSS PA 
interventions on older, overweight or obese Black women’s overall quality 
of life, lower extremity function, self-efficacy to perform PA, life 
satisfaction, depression, and decisional balance. An intention to treat 
analysis will be used for group comparisons. Results of this study will 

 
 
 
 
 
 
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inform a subsequent R01 in order to fully understand the long-term effects 
of the TOSS PA intervention in the promotion of regular PA among older, 
overweight or obese Black women. 
Objectives: 
 
The purpose of this study was to determine the acceptability and limited 
efficacy of the TOSS random control trial among older, Black women who 
were obese and its impact on increasing baseline PA behaviors compared 
to a control group. 
Endpoints: 
12 weeks post intervention 
Study Population: 
Black women: 60 years and older, with a BMI ≥ 25 kg/m2 and do not meet 
the weekly 150 minutes of physical activity 
Phase: 
n/a 
Description of Study 
Intervention: 
The intervention group will receive a daily text message from the TOSS 
study for 12-weeks. Text messages will be delivered via an automated 
system called Remind.com, which assesses treatment fidelity of the 
intervention by reviewing the text message summaries and provides the 
following data: the number of messages sent, the percentage of messages 
received and read, the percentage of people who experienced errors, and 
the number of undelivered text messages. Women randomized into the 
intervention group will also receive instructions about the FBCs and how 
to use the FBCs within the app. The FBCs are an added a strategy to 
increase peer support for PA self-efficacy and potential sustainability 
among this population. They will also receive a Fitbit to self-regulate and 
self-monitor their PA behavior.  
Study Duration: 
12 weeks 
Subject Duration: 
12 weeks 
 
 
1.2 
SCHEDULE OF ACTIVITIES (SOA) 
 
 

 
 
 
 
 
 
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2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Older, overweight, or obese Black women are less likely to meet the national guidelines for physical 
activity than their White counterparts and this is a major problem. Our proposed study helps fill the gap 
related to whether text messages based on focus group feedback will encourage older Black women to 
engage in regular physical activity and decrease sedentary behavior, which may lead to reductions in 
obesity.  
 
2.2 
BACKGROUND  
 
Black women are disproportionately burdened with obesity, overweight, obesity-related illnesses, 
functional limitations, and the lack of regular physical activity (PA) when compared to other race and 
gender groups in the United States. In Black women, 60 years and older, 58% are classified as obese and 
75% as overweight, compared to 38% (obese) and 60% (overweight) for older White women. Obesity is 
a preventable but complex, chronic, public health problem that involves socioeconomic, environmental, 
behavioral, and metabolic factors. Healthy lifestyle behaviors that include PA can help lower risk of 
many conditions such as obesity, diabetes, cardiovascular disease, anxiety, and reduce risk of 
Alzheimer’s and other related dementias.  
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
The risks and discomforts from participation in this project are no greater than those associated with 
sedentary activities  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
The importance of the knowledge to be gained from the proposed study is great. While studies 
demonstrate the many benefits of physical activity, many older Black women are still less likely to 
engage in regular physical activity. This study represents a new approach to empower older Black women 
to adopt healthier lifestyle behaviors and contribute to the current knowledge by improving our 
understanding of how physical activity text messaging may be a promising strategy to promote physical 
activity among older Black women.   
Insert text> 
 
3 
STUDY DESIGN  
 
3.1 
OVERALL DESIGN 
  
This study utilized a two-group randomized control prospective study design with quantitative and 
qualitative data collection. The 30 women were randomly assigned to either the intervention or the 
control condition (15 each) using a block randomization schedule generated in SAS for 12 weeks. 

 
 
 
 
 
 
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3.2 
END OF STUDY DEFINITION 
 
12 weeks post intervention 
 
 
4 
STUDY POPULATION 
 
4.1 
INCLUSION CRITERIA 
 
60 years and older, who have a BMI ≥ 25 kg/m2. Women who do not meet the weekly 150 minutes of 
PA, have no health conditions that would prevent or limit PA or walking, able to read text, must have 
access to a mobile phone with text receiving capability, and the ability to download a Fitbit app. 
 
4.2 
EXCLUSION CRITERIA 
 
a) concurrent participation in another PA promotion program (research or commercial), b) non-English 
speaking, and c) a contraindication to exercise as indicated by the PA Readiness Questionnaire (PAR-Q) 
unless written permission was provided from the participant’s primary care provider  
 
 
4.3 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Participants, located in Jefferson County, Alabama, were recruited through flyers emailed to community 
contacts, word of mouth, and media (e.g., Facebook, Instagram, and the university newspaper). 
 
5 
STUDY INTERVENTION 
 
5.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
5.1.1 STUDY INTERVENTION DESCRIPTION 
 
TOSS intervention group received text messages previously validated to promote physical activity every 
day for 12-weeks and were placed into Fitbit communities. The control group received a general health or 
nutrition-related text message based on CDC general health information weekly on Sundays. Fitbit-
Inspire provided the number of steps per day and minutes of daily physical activity of the participants. At 
their convenience, participants could view their PA behaviors in real-time either on the actual Fitbit-
Inspire device, or on the Fitbit app on their mobile phone. 
 
5.2 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION 
 
The 30 women were randomly assigned to either the intervention or the control condition (15 each) 
using a block randomization schedule generated in SAS.  
 
 

 
 
 
 
 
 
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6 
STUDY ASSESSMENTS AND PROCEDURES 
 
6.1 
STUDY ASSESSMENTS  
 
Physical Activity Behaviors (number of steps)  
Cardiometabolic health (weight, waist circumference, glycated hemoglobin) 
 
6.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
   
6.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
6.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) is considered “serious” if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes: 
 
• 
Death 
• 
A life-threatening adverse event (of note, the term “life-threatening” refers to an event in which 
the subject was at risk of death at the time of the event, rather than to an event which 
hypothetically might have caused death if it were more severe) 
• 
inpatient hospitalization or prolongation of existing hospitalization 
• 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
• 
or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
 
6.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
6.2.3.1 SEVERITY OF EVENT 
For adverse events (AEs), the following guidelines will be used to describe severity:  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the subject’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 

 
 
 
 
 
 
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• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of 
note, the term “severe” does not necessarily equate to “serious.” 
 
6.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the subject based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below. In a clinical trial, the study 
product must always be suspect.  
 
• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
6.2.3.3 EXPECTEDNESS  
The Principal Investigator will be responsible for determining whether an adverse event (AE) is expected 
or unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the study intervention. 
6.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study subject presenting for medical care, or 
upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Any medical condition that is present at the time that the subject is screened will be considered as 
baseline and not reported as an AE. However, if the study subject’s condition deteriorates at any time 
during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The Study Coordinator will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation.  At each study visit, the Study Coordinator will inquire about the occurrence of 

 
 
 
 
 
 
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AE/SAEs since the last visit.  Events will be followed for outcome information until resolution or 
stabilization. 
 
6.2.5 ADVERSE AND SERIOUS ADVERSE EVENT REPORTING  
All serious adverse events must be reported to the IRB according to regulatory requirements. The 
Principal Investigator will immediately report to the sponsor any serious adverse event, whether or not 
considered study intervention related, including those listed in the protocol or package insert and must 
include an assessment of whether there is a reasonable possibility that the study intervention caused 
the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported 
in accordance with the protocol unless there is evidence suggesting a causal relationship between the 
study intervention and the event (e.g., death from anaphylaxis). In that case, the investigator must 
immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the Principal 
Investigator deems the event to be chronic or the subject is stable. Other supporting documentation of 
the event may be requested and should be provided as soon as possible. 
 
6.3 
UNANTICIPATED PROBLEMS 
 
6.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
6.3.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   

 
 
 
 
 
 
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• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 10 working days of 
the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB within 10 working days of the investigator becoming 
aware of the problem.  
 
 
 
7 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
7.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
7.1.1 INFORMED CONSENT PROCESS 
 
Before the orientation sessions and collecting any data, written informed consent will be obtained from 
each participant in a private office and the participant will be given a copy of the consent form.  The PI 
or a member of the research team will read the consent form to the participants and each participant 
will be given the opportunity to discuss the consent form and ask questions. Each participant will also be 
provided with the PI contact telephone number for further clarification or information regarding the 
study. 
7.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO SUBJECTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
subject and written documentation of informed consent is required prior to conducting study screening 
procedures. A separate screening consent form will not be used. 
 
7.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the subject will be asked to read and review the document. The 
investigator will explain the research study to the subject and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the subject’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research subjects.  Subjects will have 
the opportunity to carefully review the written consent form and ask questions prior to signing. The 
subjects should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The subject will sign the informed consent document prior to any 
procedures being done specifically for the study. Subjects must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice. A copy of the 
informed consent document will be given to the subjects for their records. The informed consent 
process will be conducted and documented in the source document (including the date), and the form 
signed, before the subject undergoes any study-specific procedures. The rights and welfare of the 
subjects will be protected by emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 
7.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 

 
 
 
 
 
 
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provided by the suspending or terminating party to regulatory authorities.  If the study is prematurely 
terminated or suspended, the Principal Investigator (PI) will promptly inform study subjects and the 
Institutional Review Board (IRB), will provide the reason(s) for the termination or suspension.  Study 
subjects will be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the IRB. 
 
7.1.3 CONFIDENTIALITY AND PRIVACY  
Subject confidentiality and privacy is strictly held in trust by the participating investigators and their 
staff. Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the Principal Investigator.  
 
All research activities will be conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB) may inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study. The clinical study site will permit access to 
such records. 
 
The study subject’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB and/or Institutional policies. 
 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, will be 
stored at the UAB Department of Otolaryngology research office. This will not include the subject’s 
contact or identifying information. Rather, individual subjects and their research data will be identified 
by a unique study identification number. The study data entry and study management systems used by 
research staff will be secured and password protected.  
 
7.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 
The site will perform internal quality management of study conduct, data collection, documentation and 
completion.  Quality control (QC) procedures will be completed by the Data Manager during data entry 
into the appropriate CRF. Any missing data or data anomalies will be communicated to the Study 
Coordinator for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated are collected, documented (recorded), and reported in compliance 

 
 
 
 
 
 
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with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and 
applicable regulatory requirements.  
 
The site will provide direct access to all trial related sites, source data/documents, and reports for the 
purpose of monitoring and inspection by local and regulatory authorities. 
 
7.1.5 DATA HANDLING AND RECORD KEEPING  
 
7.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
Principal Investigator. The Principal Investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hard copies of source document worksheets will be used for recording data for each subject enrolled in 
the study.  Data recorded in the case report form (CRF) derived from source documents should be 
consistent with the data recorded on the source documents.  
 
7.1.5.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 3 years after the completion of the study. These 
documents should be retained for a longer period, however, if required by local regulations.  
 
7.1.6 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol requirements. The 
noncompliance may be either on the part of the subject, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the Principal Investigator to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation.  Protocol deviations must 
be sent to the reviewing Institutional Review Board (IRB) per their policies. The Principal Investigator is 
responsible for knowing and adhering to the reviewing IRB requirements.  
 
7.1.7 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.   
 
 
 

 
 
 
 
 
 
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7.2 
ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LSMEANS 
Least-squares Means 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States