Investigating Withdrawal Symptoms as Barriers to Reducing Sugar-sweetened Beverage Consumption Among Children
Phase: NA
Conditions: Pediatric Obesity, Diet, Food, and Nutrition
Sponsor: George Washington University

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RESEARCH PROTOCOL 
Required Elements
TITLE: Investigating withdrawal symptoms as barriers to reducing sugar-sweetened 
beverage consumption among children: pilot intervention study
IRB #: NCR191271
VERSION DATE: June 3rd, 2019
RESEARCH PLAN
A.
Specific Aims
 
Specific Aims and Hypotheses:
1. Examine the feasibility of removing caffeinated sugar-sweetened beverages (SSB) from 
the child diet. We hypothesize that caffeinated SSB avoidance will be feasible among 
children, but that compliance will be lowest among those assigned to sparkling water, 
devoid of both caffeine and sugar. Compliance with beverage assignments will be assessed 
using daily online questionnaires and weekly dietary recalls.
 
2. Explore the extent to which caffeinated SSB removal induces withdrawal symptoms. We 
hypothesize that replacement of caffeinated SSBs with caffeine-free SSBs, or sparkling 
water will induce withdrawal symptoms compared to control (usual caffeinated SSB 
consumption). Participants will complete a child-adapted version of the validated Caffeine 
Withdrawal Symptoms Questionnaire (CWSQ) at baseline and daily (online) during the 
intervention.
B.
Background and Significance 
Sugar-sweetened beverages (SSBs) significantly contribute to sugar and calorie intakes, 
and their consumption is associated with metabolic disease.1 Sweetened beverages  also 
account for the majority of pediatric caffeine consumption.2 It is well-established that 
habitual caffeine use leads to dependence in adults3 and evidence for sugar dependence 
has been documented.4 However, caffeine and/or sugar dependence related to sweetened 
beverage consumption has not been evaluated, and determinants of their consumption 
among youth are severely understudied. It is critical to elucidate whether they may be 
physiologically or psychologically dependent on these beverages, particularly SSBs, 
which contain both caffeine and sugar.
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The purpose of this pilot study is to replace caffeinated SSB’s with either caffeinated SSBs 
provided by the study team (control) or with caffeine-free and unsweetened alternatives (also 
provided by the study team) for 2 weeks, among children who habitually consume 
caffeinated SSBs.
Lowering SSB consumption is a central component of lifestyle behavior change aimed at 
preventing and managing obesity,5 yet effective reduction of SSB intakes has been met 
with many challenges.6  While their palatability, accessibility, publicity, affordability, and 
social acceptability contribute to frequent and sustained SSB consumption, their caffeine 
and sugar content may further encourage continued intake. Although adverse health 
consequences of excessive SSB consumption are well documented7, the extent to which 
their pleasant taste (due primarily to their sugar content) and post-ingestive effects (due to 
their sugar and/or caffeine content) positively reinforce consumption among children has 
not been elucidated. It is particularly important to understand the determinants of 
caffeinated SSB use in children because beverage consumption habits in childhood will 
likely be sustained into adolescence and adulthood and will contribute to obesity and 
metabolic disease risk later in life. This is particularly important to study among children 
from low-income and minority backgrounds, as these children have the highest rates of 
SSB intake and the highest prevalence of obesity. 
Examining the feasibility of removing caffeinated SSBs and exploring whether this induces 
withdrawal symptoms among youth will enable us to investigate independent and combined 
effects of avoiding sugar, caffeine, or both, which will be integral to the design of a future 
larger scale intervention and to inform ongoing and future efforts for reducing SSB 
consumption. Findings will provide a comprehensive picture of the extent to which children 
are dependent on sugar and/or caffeine in SSBs and will inform whether their removal is 
feasible. If withdrawal symptoms are observed, this will have important implications for 
future efforts to limit consumption.
C.
Preliminary Studies
Not applicable. 
D.
Research Design and Methods 
This study includes an intervention to remove caffeinated SSBs and to explore whether 
caffeinated SSB removal induces withdrawal symptoms in 8-11 year-old (3rd-5th grade) 
male and female children residing in the Washington, D.C. area. We expect that half of 
our total sample will be comprised of boys (n=30) and half of girls (n=30). Children 
under 8 are being excluded because of a lack of cognitive ability to fully understand the 
study components and their potential inability to complete study requirements that take 
place outside of the presence of the GW researchers. We are specifically recruiting 
children 8-11 years old because compared to older children/adolescents, this age range 
generally is under greater parental supervision and thus, these children are more likely to 
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comply with the intervention.  We plan to study older children/adolescents in a future 
study. We will not exclude subjects on the basis of race/ethnicity and we anticipate that 
our study sample will be distributed proportionally to the race/ethnic distribution of the 
greater Washington metropolitan area, from which we will recruit. This research topic 
pertains to children from all race/ethnic backgrounds.  
For the pilot intervention study, the primary purpose is to evaluate the feasibility of the 
intervention and therefore, formal sample size calculations for clinical outcomes were not 
performed. 
Eligible children will be identified through community organizations (e.g. camps, after 
school programs, schools) and word of mouth. The child will be provided with study 
information by Dr. Meni and a trained research assistant (RA) on site. After obtaining 
informed consent (parent/guardian(s)) and assent (child), child volunteers will complete 
a screener questionnaire to determine initial study eligibility. Eligible and interested 
participants will be scheduled for a baseline visit, either at the Milken Institute School of 
Public Health or at a community location (e.g. community center, library) convenient to 
the participant. 
Beginning at the baseline visit (in person) and continuing daily throughout the 
intervention (online), participants will be asked to complete a child-adapted version of the 
validated Caffeine Withdrawal Symptoms Questionnaire (CWSQ). During the baseline 
visit, child participants will taste a small sample of each study beverage in pairs and will 
rate which beverage they like better and which beverage tastes sweeter using the enclosed 
beverage taste testing form. Child participants will be randomized into one of three study 
arms, where they will be instructed to replace their usual caffeinated SSBs with either: 
caffeinated SSB's provided by the study team, caffeine-free SSBs (caffeine-free Pepsi) or 
unsweetened sparkling water (LaCroix), compared to control (regular Pepsi consumption) 
for two weeks. All beverages will be provided by the study team, including drinks for the 
control group. After randomization, participants (child and parent together) will complete 
a daily online compliance questionnaire. 
An outline of the schedule of study activities is below:
Time
Activity
Baseline Study Visit (Day 0)
1.5 hours
 
Consent/assent

Height and weight

Complete in-person Caffeine 
Withdrawal Symptoms Questionnaire 
(CWSQ) with parent and child [this is 
called Daily Feelings Questionnaire in 
the Assent Form for kid-friendly 
language]

Dietary recall (parent and child)
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
Beverage taste testing (child)

Randomization and counseling 
regarding intervention (parent and child)

Provision of study beverages
Intervention (Days 1-14)
Total of 1 hour per week

Parents receive three times weekly text 
message/email/phone reminders (based 
on participant preference) from study 
team

Parent and child together complete daily 
online CWSQ

Parent and child together complete daily 
online compliance survey

Child participant consumes assigned 
study beverages
Mid-intervention Visit Or Telephone 
Check-in (after first week of 
intervention)
 
         ~30-45 minutes

Complete in-person Caffeine 
Withdrawal Symptoms Questionnaire 
(CWSQ, parent and child together)

Dietary recall (parent and child 
together)

Provision of additional study beverages 
if needed

Participants and their parents 
encouraged to ask questions or express 
concerns 
Follow-up visit (Day 15)
1.5-2 hours

Complete in-person Caffeine 
Withdrawal Symptoms Questionnaire 
(CWSQ, parent and child together)

Dietary recall (parent and child 
together)

Beverage taste testing (child participant)

Return empty study beverages 

Qualitative interview (~20 minutes, 
parent and child together)
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Details of all study procedures are described below:
Study Procedure                                       Description 
Height and 
weight
Child participant’s height and weightwill be measured using a 
portable scale and stadiometer. 
Caffeine 
Withdrawal 
Symptoms 
Questionnaire 
(CWSQ)
Parent and child participants will together complete a child-adapted 
version of the validated CWSQ8 in person at baseline, and online 
daily throughout the intervention. Dr. Meni and/or a trained RA will 
assist with CWSQ completion at baseline and will counsel 
participants regarding filling out the online questionnaire.
 
24 hour dietary 
recalls
Participants will be asked (with the help of their parent) to report 
everything that they eat and drink over the past 24 hours. 24-hour 
recalls will be conducted at baseline (in person), after 1 week of the 
intervention (in person or via phone depending on participant 
preference), and at follow-up (in person).  
Beverage taste 
testing
Prior to randomization, child participants will taste pairs each study 
beverage (10 mL) in randomized order and rate which beverage they 
like better and which beverage tastes sweeter using the taste enclosed 
taste testing form. Participants will rinse with water between each 
test. Taste testing will be completed in a private room and supervised 
by trained RAs. Child participants will also complete taste testing at 
follow-up. 
Compliance 
questionnaires
Participants (child and their parent) will complete an online, 4-item 
questionnaire daily throughout the intervention to assess compliance 
(percentage of assigned beverages consumed, assessment of whether 
caffeinated SSB were consumed in violation of the study protocol, 
and if so, the brand and quantity consumed).
Randomization 
and Blinding
Following baseline assessments, child participants will be 
randomized using sex-stratified permuted block randomization into 
one of three arms:  1) caffeine-free SSBs (caffeine-free Pepsi) 2) 
unsweetened sparkling water (LaCroix) or 3) control (Pepsi). 
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Assigned beverages will replace usual caffeinated SSB consumption, 
as assessed at enrollment.
Beverage 
distribution
A two-week supply of beverages (corresponding to randomization 
and the amount of SSBs typically consumed) will be provided. If a 
participant runs out of beverages, the study team will provide 
additional beverages. Children will be counseled to drink only the 
study drinks provided or water and not to consume any other 
beverages during the two week intervention. Parents will also be 
counseled regarding encouraging their child to consume only the 
study beverages or water throughout the two week study period. 
Compliance and 
reminders
Compliance will be assessed by collection of empty beverage 
containers. Empty containers will be picked up by the study team at 
the end of the intervention to minimize participant burden. If a 
participant is provided with additional beverages, empty containers 
will be requested prior to distribution of more beverages. Compliance 
will be further monitored during dietary recalls.
Mitigation of 
withdrawal 
symptoms
If a child experiences headaches, nausea, or other discomfort, they 
will be asked to report symptoms using the CWSQ before taking pain 
or anti-nausea remedies. Children and their parents will be 
discouraged from using over-the-counter medications, unless the 
severity of the symptoms are reported to be above a pre- determined 
threshold (rating of 4 or higher on the CWSQ Likert scale). In 
addition, participants will be strictly instructed not to use any pain 
remedy containing caffeine.
 
           Data analysis:
Caffeine withdrawal scores will be collected using the CWSQ, completed by the child 
and parent together. Peak withdrawal symptoms will be operationalized as CWSQ scores 
reported within the initial 72 hours of the intervention, between the three groups. 
Univariate analyses and one-way ANOVA will be used to assess group differences in our 
primary (measures of compliance with beverage intervention) and secondary (withdrawal 
symptoms) study outcomes. 
Dietary recalls will allow us to assess adherence to the study beverages as replacements 
for habitual caffeinated SSBs and to determine if caffeinated SSB removal impacts 
dietary choices. While we acknowledge limitations inherent to self-report dietary 
assessment, dietary recalls are sufficient for capturing beverage consumption data and 
will enable us to determine whether participants change their diet to compensate for 
caffeine restriction.
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Compliance with beverage consumption will be assessed using beverage/compliance logs 
(completed by the parent and child together). We will operationalize compliance as the 
number of days in which participants consumed the study beverages, the total number of 
study beverages consumed during the intervention period, as well as any consumption of 
caffeinated SSB, juices etc. (in violation of the study protocol). Importantly, participants 
are being instructed simply to consume the study beverages in the same manner that they 
would normally consume their usual caffeinated sugar-sweetened beverages.  They will 
not be assigned to consume a certain number of study beverages, but instead instructed to 
replace their usual beverages with the study drinks  or water throughout the intervention 
period. 
 
Liking of study drinks may affect compliance and we will therefore run exploratory 
multivariable linear regression models including taste ratings as a potential confounder, 
along other potential covariates such as sex, race/ethnicity, age, weight, and volume of 
habitual SSB consumption. While we recognize that we are not sufficiently powered for 
multivariable regression models including a large number of covariates, these data will be 
critical in informing sample size calculations for our subsequent R01 proposal. We will 
use an intention to treat (ITT) approach and will minimize loss to follow-up by 
maintaining close contact with participants. All analyses will be conducted using SAS 
9.4.
 
There are several potential limitations to our proposed study.  The first is that successful 
recruitment and data collection with children presents unique challenges. However, we 
are recruiting from a large sample of children throughout the greater Washington 
metropolitan area and our team has extensive experience conducting research with 
children. Another challenge is that participants in the clinical study may consume 
caffeinated SSBs or other caffeine- and/or sugar-containing products, which would 
minimize the likelihood of observing withdrawal symptoms. We will account for this by 
assessing diet using 24-hour dietary recalls, as well as daily online compliance 
questionnaires. We also acknowledge that those who do not consume still/seltzer water 
may be opposed to consumption. However, we have successfully randomized seltzer 
water naïve participants to consume them previously. It is also possible that the opaque 
wrapper may be insufficient to maintain blinding of study beverage assignments. 
However, transferring commercially available carbonated beverages to a separate and 
unidentifiable container is not possible, as opening containers prior to consumption 
would result in lost carbonation and altered taste.
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E.
Study Population – (Gender and Minority Inclusions):
The subject population will be comprised of 60 children, both male and female, aged 8-11 
(3rd to 5th grade) and their respective parent/legal guardian, for a total of 60 children and 60 
parents. In addition to age range, inclusion criteria consists of reporting regular consumption 
of caffeinated sugar-sweetened beverages, defined in this study as consuming ≥ 12 ounces of 
caffeinated SSB’s per day. Children under 8 years of age will be excluded to ensure that 
participants are able to adequately articulate their reasons for SSB consumption. Children 
who have a poorly managed chronic medical condition, a current or prior eating order 
diagnosis, or who report regular consumption (≥ 1 serving per week) of other caffeinated 
beverages, such as energy drinks, regular coffee, or hot tea will also be excluded to ensure 
that we are adequately able to evaluate study aims and outcomes. 
We will enroll children whose parents speak Spanish, as long as the child speaks English.  
This is necessary because sugar-sweetened beverage consumption is particularly prevalent in 
Hispanic/Latino families. We will protect these subjects by having members of our research 
team who are fluent in Spanish communicate with them throughout the study to make sure 
that completely understand the study rationale and procedures and so that we can easily 
address any of their questions or concerns.
F.
Human Subjects (Risks & Benefits)
 
All sources of research material will be obtained from the human subjects in this study for 
research purposes. Materials consist of self-reported data for the following items:
 
Name

Age

Contact information (phone #, email) – used only for contacting active participants 
to schedule study visits

Race/ethnicity

Gender

24-hour dietary recalls

Daily caffeine withdrawal symptoms questionnaires (CWSQs)

Daily compliance surveys
Additionally, anthropometric measurements of height and weight will be taken on-site at the 
baseline and follow-up visits.
Recruitment Plan
The study will be advertised to parents of children 8-11 years old (3rd-5th grade) through 
on-site recruitment by Dr. Meni and a trained study research assistant (RA). Recruitment 
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will take place in-person at community sites and/or events, while ensuring minimal 
disturbance to site/event flow. If interested in participating, the RA will administer a brief 
eligibility checklist (enclosed), and if eligible, participants will be asked if they are 
interested in participating. Given the large volume of children served by the participating 
sites, we do not anticipate any problems recruiting and retaining a diverse sample of 
children. If the potential participant has questions that the research assistant (RA)/clinical 
study coordinator (CRC) cannot answer, the RA/CRC will immediately contact Dr. 
Meni on her cell phone to provide clarification. Recruitment techniques used will include 
flyers or other print media. Subjects will not be recruited through any use of records.
 
The study team will ensure that this study and all recruitment is conducted in full 
conformity with the Regulations for the Protection of Human Subjects of Research 
codified in 45 Part 46 of the Code of Federal Regulations.
Participant confidentiality is strictly held in trust by the participating investigators, their 
staff, the sponsor and their agents. This confidentiality is extended to cover information 
relating to participants. 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 sponsor.
Informed Consent
At the screening visit, a study team member will explain the study to the parent and child. 
The study team member will first go over the consent form with the parent, prior to going 
over the assent form with the child. 
 
Parents and children will be asked to read and review the consent and assent form, 
respectively. Both (the parent and the child) will have the opportunity to ask any questions 
before signing the respective form. Participant consent (parent) or assent (child) will then be 
documented by having participants sign the document.  All parents and children will receive 
a verbal lay explanation of the purposes, procedures, and potential risks of the study and of 
their rights as research participants. 
 
Children and their parent will be given the opportunity to discuss the study with their friends 
and family members and will be welcome to take the consent or assent form home prior to 
agreeing to participate. The parent will sign the informed consent document(s) and the child 
will sign the assent document prior to any study procedures. The parent may withdraw 
consent at any time throughout the course of the study. A copy of the informed consent 
document will be given to the parent for their records. A copy of the assent document will be 
given to the child.
G.
Risks and Side Effects:
It is important to note that all research studies have some risk; however, risks associated 
with participation in this study are minimal. Potential risks are listed in the table below:
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Risk/Side Effect
Probability
General: The child may find the time needed to complete 
this research study an inconvenience.
Rare
Confidentiality:  It is possible that other participants and 
individuals external to the study may find out that a 
participant took part in the research, in which case, 
information derived may be conveyed to others external to 
the group.
Occasional
Questionnaires: Completing the beverage screener, 
CWSQ, and compliance questionnaires may be 
uncomfortable, burdensome, or embarrassing for some 
participants. 
Occasional
Dietary Recalls:  Completing dietary recalls may also be 
uncomfortable, burdensome, or embarrassing for some 
participants. 
Rare
Beverage Taste Ratings: While performing the taste tests, 
some children may find the taste unpleasant. 
Occasional
Study Intervention: Participants may experience 
withdrawal symptoms such as headaches, fatigue, changes 
in mood, difficulty concentrating, and gastrointestinal 
discomfort.
Common
Consumption of Assigned Study Beverages: Some 
participants may not like the taste of the beverages 
provided and may find consuming them for 2 weeks to be 
uncomfortable. 
Occasional
This study is minimal risk since the procedures do not exceed the probability and 
magnitude of physical or psychological harm than those ordinarily encountered in daily 
life, or in routine medical, or psychological examinations. Because the risks associated 
with the study are minimal, the contribution of our study to understanding effects of 
caffeinated SSB restriction outweighs the risks. Thus, the risk-to-benefit ratio of the study 
is low. The study procedure and the potential risks associated are described below and 
will be disclosed in the study consent and assent forms. 
Steps taken to minimize risk and to protect subjects’ welfare:
General: The majority of procedures will be conducted remotely using the internet or 
telephone, which will reduce participant burden. 
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Dietary recalls: Data collected will be de-identified to ensure that responses are not directly 
linked to the subject’s identity and are linked only through a code retained by the Principal 
Investigator.
Beverage Taste Ratings: We have minimized this risk by asking each subject to consume 
only a very small amount of each study beverage. 
Study Intervention: Withdrawal symptoms will be closely monitored through the completion 
of daily caffeine withdrawal symptoms questionnaire. In the event that adverse side effects 
are observed, Dr. Meni will be contacted immediately and advise appropriate action.
Consumption of Study Beverages: All study beverages are commercially available 
beverages.  Flavored unsweetened sparkling water will be provided to help with palatability 
Confidentiality: We will minimize risks by de-identifying participant data and linking 
research data collected to the participant's name only through a code retained by the 
Principal Investigator.
H.
Benefits:  
There are no direct benefits to participation in this study. However, because the study aims 
to understand whether removal of caffeinated SSBs from the diet is feasible, this pilot study 
will inform the design of future interventions and policies for lowering SSB consumption 
in youth.
I.
Outside Consultants/Collaborators 
Not applicable. 
J.
Contractual Agreements  
  
             Not applicable. 
K.
Costs To Subjects:
The George Washington University will provide the study beverages to subjects for free. 
Subjects will not be charged for anything else we do that is part of the study and as such, 
there are no costs to participants. 
L.
Conflicts Of Interest:
Salary support for this study is provided by the National Institute of Health and the Milken 
Institute School of Public Health at the George Washington University.  REDCap® support 
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is provided by The Clinical and Translational Science Institute (CTSI) at Children’s 
National. All key study personnel will follow the Human Research Protections Program 
Investigator, Study Staff, and Family Member Conflicts of Interest (COI) Policy. The PI nor 
any of the study staff members have conflicts of interest to report. 
M.
Confidentiality:
All procedures will take place in a private room to ensure the participant’s privacy. The 
study participant’s contact information will be securely stored at the study site for internal 
use during the study. At the end of the study, all research records will be stored in a secure 
location for the time period dictated by the sponsor and institutional regulations. The 
research data will not include the participant’s identifying information. Identifiers including 
name, phone number, and email address will be collected for the clinical pilot study; 
however, all data will be de-identified and identifiers will not be disclosed. The study data 
entry and study management systems used by research staff will be secured and password 
protected. Confidentiality of all study information will be maintained by assigning 
participants code numbers, which will be used for entering and storing data electronically. 
Data that have been collected as a part of this study will be retained in secure, password-
protected electronic files until 6 years after enrollment of the last participant.
Participant confidentiality is strictly held in trust by the participating investigators, their 
staff, the sponsor and their agents. This confidentiality is extended to cover information 
relating to participants. 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 sponsor.
Data Storage
All data will be entered and managed using RedCap, a password-protected data management 
system.  Data will be entered by trained research assistants and Dr. Meni will check RedCap 
weekly during periods of active data collection to ensure that data entry is correct and up to 
date. Dr. Meni will keep all study records in a locked cabinet for 6 years after enrollment of 
the last participant.
Data Analysis
Data analysis will take place on-site at The George Washington University. Data security 
will be maintained by precluding personal or identifying data from analysis. Additionally, 
data analysis will take place on password-protected computers and access to data will be 
restricted to participating investigators, their staff, the sponsor and their agents. No 
information concerning the study or the data will be released to any unauthorized third party 
without prior written approval of the sponsor.
Destroying Data/Study Materials
Six years following enrollment of the last study participant, electronic data files will be 
deleted. Paper files will be shredded.
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Protecting the Welfare of Vulnerable Participants
The privilege of confidentiality does not extend to information about sexual or physical 
abuse of a child. If any member of the research team has or is given such information, he or 
she is required to report it to the appropriate authority or agency, such as child protective 
services, a law enforcement agency, or your State’s toll-free child abuse reporting hotline. 
The obligation to report includes past and current alleged or reasonably suspected abuse as 
well as past or current known abuse. Examples of such abuse include physically harming 
your child or having inappropriate sexual contact with your child.
N.
Subject Compensation: 
Pilot study participants will receive compensation of up to $175, including $75 for the 
baseline visit involving consent/assent, questionnaire completion, taste testing, dietary 
recall, $25 for the mid-point visit after Week 1, and $75 for the follow-up visit including 
questionnaire completion, taste testing, dietary recall, and qualitative in-depth interview. 
Participants who withdraw from the study will be appropriately compensated for the 
study activities that they did complete.  In addition, participants will be provided with 
additional compensation to cover the cost of travel to/parking at the GWSPH.
O.
Facilities and Equipment
There is no major equipment required for this project.   The primary facilities that will be 
used are the following:
Food and Nutrition Assessment Core (FNAC): The FNAC is located within the Milken 
Institute School of Public Health and provides state-of-the-art methods for dietary data 
collection from research participants. FNAC services include: 1) collection of dietary 
recall (in person or by telephone) data using the Nutrient Data System for Research 
(NDSR); 2) nutrient analysis of food records, food frequency questionnaires, menus, and 
recipes; and 3) consultation on appropriate data collection approaches for nutrition 
components of research studies. The FNAC interviewing room is approximately 400 sq. 
feet and includes 2 interviewer cubicles, each with a high-speed computer, monitor, 
keyboard, phone, head-set, and desk space. Resource support equipment includes a copy 
machine, printers, a fax machine, and other standard office equipment.  This will allow us 
to conduct dietary recalls in person throughout the study and to rigorously analyze the 
data.
Psychology of Exercise and Nutrition Sciences Lab: There is space in the GWSPH 
building for behavioral studies. This lab space is dedicated for research use and includes 
three desks and two PC computers equipped to perform word processing, as well as 
statistical analyses using SPSS/PAWS software. This lab also includes ample space for 
storage of various research resources including adequate filing cabinets for the use of 
securing and storing hard data.  These computers will be critical for facilitating efficient 
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data entry and regular follow-up with participants via online questionnaires and text 
message reminders.
P.
References & Literature Cited 
1.
Hu FB. Resolved: there is sufficient scientific evidence that decreasing sugar-sweetened 
beverage consumption will reduce the prevalence of obesity and obesity-related diseases. 
Obes Rev. 2013;14(8):606-619.
2.
Knight CA, Knight I, Mitchell DC, Zepp JE. Beverage caffeine intake in US consumers 
and subpopulations of interest: estimates from the Share of Intake Panel survey. Food 
Chem Toxicol. 2004;42(12):1923-1930.
3.
Juliano LM, Griffiths RR. A critical review of caffeine withdrawal: empirical validation 
of symptoms and signs, incidence, severity, and associated features. Psychopharmacology 
(Berl). 2004;176(1):1-29.
4.
Avena NM, Rada P, Hoebel BG. Evidence for sugar addiction: behavioral and 
neurochemical effects of intermittent, excessive sugar intake. Neurosci Biobehav Rev. 
2008;32(1):20-39.
5.
Welsh JA, Lundeen EA, Stein AD. The sugar-sweetened beverage wars: public health 
and the role of the beverage industry. Curr Opin Endocrinol Diabetes Obes. 
2013;20(5):401-406.
6.
Vargas-Garcia EJ, El Evans C, Cade JE. Impact of interventions to reduce sugar-
sweetened beverage intake in children and adults: a protocol for a systematic review and 
meta-analysis. Syst Rev. 2015;4:17.
7.
Malik VS, Popkin BM, Bray GA, Despres JP, Hu FB. Sugar-sweetened beverages, 
obesity, type 2 diabetes mellitus, and cardiovascular disease risk. Circulation. 
2010;121(11):1356-1364.
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Q.
Appendix 
IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

IRB #     Version
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IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019

IRB #     Version
Page 1 of 26
IRB NUMBER: NCR191271
IRB APPROVAL DATE: 06/07/2019