You are on page 1of 7

Research Article

Children as Subjects in Nutrition Research: A Retrospective


Look at Their Perceptions
Tamar Kafka, MS, RD; Christina Economos, PhD; Sara Folta, PhD; Jennifer Sacheck, PhD
ABSTRACT
Objective: To explore childrens motivations for and perceived benets and barriers to nutrition research
participation. To explore childrens perspectives on how to improve the research experience.
Design: Seven focus group sessions were conducted during March 2008 with research participants from
a trial that examined the effects of pre-exercise snacks on physical activity and exercise stress in children.
The Health Belief Model for Behavior Change served as the framework for understanding perceived benets and barriers to research participation and cues to action to help childrens readiness for future research
participation.
Setting: Indoor sports center in Acton, Massachusetts.
Participants: Thirty-ve children, 15 males and 20 females, aged 710 years.
Phenomenon of Interest: Childrens participation in nutrition research.
Analysis: Transcripts were reviewed, coded, and sorted according to recurring trends and patterns using
NVIVO software.
Results: Participants were overwhelmingly motivated to participate in research because of nancial
incentives. The biggest barrier to participation was anxiety over nger pricks. Children suggested demonstrating different aspects of data collection during recruitment to reduce trepidation and using distraction
techniques to improve the experience during anxiety-provoking data collection.
Conclusion and Implications: Themes for benets and barriers to research participation were identied. Data also provide a guide to promote readiness and to improve the research experience for children
in future nutrition trials.
Key Words: nutrition, physical activity, children, focus groups, Health Belief Model for Behavior
Change (J Nutr Educ Behav. 2011;43:103-109.)

INTRODUCTION
In the late 1990s, the National Institutes of Health and the Department of
Health and Human Services developed
new guidelines and regulations to
increase the participation of children
in research. This step was taken to
help ensure that treatments for disorders and conditions that affect children
would be developed and substantiated
with data.1,2 To promote enrollment
in trials, it is therefore critical for
researchers to understand perceived
barriers and motivators for children
and to improve communication.
Additionally, investigators should
understand childrens perceptions of

their involvement in research to


improve the experience for this
vulnerable population.
Most of the evidence exploring
motivations for enrolling children in
research studies relies on parental opinion.3-10 These studies exclusively
evaluate the perceptions of parents
who have children with a chronic
condition or disease who were
enrolled in a drug or treatment trial.
The primary reasons cited for why
parents enroll their children as
participants in research are the hope
for a treatment or to altruistically
contribute to medical research. In
a PubMed search from 1990 through
November 2008, only 2 studies were

The Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy, The John
Hancock Center for Physical Activity and Nutrition, Tufts University, Boston, MA
Address for correspondence: Tamar Kafka, MS, RD, The John Hancock Center for Physical
Activity and Nutrition, Tufts University, Jaharis Building, 150 Harrison Ave, Boston, MA
02111; Phone: (778) 322-0602; Fax: (617) 636-3781; E-mail: tkafka@gmail.com
2011 SOCIETY FOR NUTRITION EDUCATION
doi:10.1016/j.jneb.2010.03.002

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011

found that retrospectively investigated


childrens own motivations for
participation in a clinical trial. In
a study by Fogas et al,11 25 children
who had been enrolled in a drug trial
for attention-decit hyperactivity disorder were interviewed about their reasons for participating in the original
trial. Forty-seven percent of the children cited self-interest (for money, to
get once-a-day pills) as the top reason,
and 39% cited altruism (to help science,
to help other kids) as the second most
popular reason for study participation.
Similar responses were seen in another
retrospective study by McGuinness
et al.12 Thirty-six young patients with
type 1 diabetes responded to a questionnaire after having participated in a trial
comparing specic insulin regimens.
Fifty-one percent of children cited selfinterest (to improve blood sugar control, to learn more about diabetes) as
the most commonly cited reason, and
19% reported altruism (to help other
people with diabetes) as the second
most
cited
reason
for
study

103

104 Kafka et al
participation. To the authors knowledge, no studies have explored the motivations of children to participate in
research in the absence of a disease or
condition.
Research looking retrospectively at
childrens perceptions of participating
in research is also limited. The same
studies by Fogas et al11 and McGuinness et al12 were again the only trials
identied that asked children about
their perceptions of participating in
a trial. Fogas et al11 asked the children
how they viewed their involvement
in research, including perceived distress to having blood drawn (33%
reported it did not hurt, and almost
50% responded that it hurt a little),
voluntariness (about 90% of subjects
believed they could have refused trial
participation), and satisfaction with
being involved in the study (over
97% of the children reported being
happy about being involved).
McGuinness et al12 explored childrens impressions of an intervention
modality. They asked participants
about having increased clinic visits
(86% indicated a positive response)
and whether they planned to remain
on the more intensive insulin regimen
established during the trial (97% indicated they intended to maintain the
regimen). No studies could be found
that explored childrens perceptions
of how nutrition research could be improved for other children in the future.
Recent national data show that 32%
of children in the United States are
overweight or obese,13 with prevalence
increasing with age from 2 to 19
years.14,15 Overweight and obesity
increase the risk of many diseases and
health conditions, including type 2
diabetes, coronary heart disease, and
some cancers.16 Balanced nutrition is
one important component of maintaining a healthful body weight, therefore it is important to understand the
factors that motivate childrens participation in nutrition research as well as
their experiences in this research. This
knowledge will help promote enrollment and improve experiences in
nutrition and physical activity-related
trials, as more are being called for in
this population.
In the Health Belief Model for
Behavior Change, 4 constructs
(perceived barriers, perceived beliefs,
perceived susceptibility, perceived
severity) and mediating factors are

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011


explored in attempt to predict health
behaviors.17 Under the framework of
this model, focus groups for the present study were designed to investigate
the perceived benets and barriers
children had that could help explain
why they chose to take part in
a health-related action, in this case,
participation in nutrition research
and to identify potential cues to action, a mediating factor, that could
play a role in activating readiness to
participate in nutrition trials with
other children in the future.

METHODS
Study Design and Population
Focus groups were conducted over 1
weekend in March 2008 with children
who had participated in the Healthy
Snacking for Soccer Playing Kids study
(HSSP) during the previous 6 weeks.
The objectives of the HSSP study were
to examine how the nutrient density
and antioxidant content of 3 snacks
affected exercise intensity, post-game
fatigue, blood glucose, and biochemical
markers of stress and immune status in
7- to 10-year-old recreational and competitive soccer players.18 One hundred
fteen male and female indoor soccer
players were randomized to 1 of the
3 snacks (a nutrient-dense/highantioxidant raisin oatmeal bar, a highsugar/starch graham peanut butter bar,
and a low-antioxidant, higher-sugar/
starch crispy rice marshmallow treat),
which they consumed 1 hour before 1
soccer game. Children were then monitored during the soccer match to examine the effect of each snack on exercise
intensity using accelerometry, on
subjective assessments of physical
and mental fatigue using a selfadministered questionnaire, and on
pre- to post-match changes in blood
sugar with a nger prick and biochemical markers of stress measured by salivary cortisol and immunoglobulin A
collected with a swab. All participants
played in indoor soccer leagues at
a sporting complex in Acton,
Massachusetts (MA). Acton is located
in Middlesex County, MA, where the
population is primarily (87.2%) white
non-Hispanic and the median household income is $91,624 (United States
median is $41,994).19
Focus group participants were
recruited by sending an e-mail to

team coaches whose teams had completed the HSSP study. Coaches then
requested participation from individual participants, also through e-mail.
All of the 14 teams (a total of 101 children) who had completed the HSSP
study at the time the focus groups
were conducted were invited to participate in the focus groups. Focus group
times were then arranged with all
coaches who responded to the e-mail
indicating individual participants
were interested in participating. All
individuals who showed up to participate in the focus groups were included
irrespective of age, sex, or the number
of participants per focus group, in order
to be able to generate responses from as
great a range of participants as possible
including team, age, and sex. Participants received a $10 gift card to a sporting goods store and either a water
bottle or a soccer ball as incentives to
participate in the focus groups.
Participants
provided
written
assent and parents signed informed
consent
forms
before
their
participation in the focus groups.
The Institutional Review Board at
Tufts University gave human subjects
research approval for this project.

Focus Group Methodology


Focus groups were led by 2 focus
group facilitators (a moderator who
led the discussion and a recorder
who took notes) with training and
previous experience in conducting focus groups with children. Each session
was recorded on audiotape for subsequent transcription. Sessions typically
lasted 25 minutes.
Focus group facilitators told children that the purpose of meeting
was to learn how to make research
better for children who are in future
studies. To increase the possibility
that children were comfortable speaking out differently among peers, they
were told at the start of the session
that there were no right or wrong answers to the questions and that they
were to feel free to say exactly what
they thought, even if it was different
than what the other kids thought.
Facilitators explored why children
agreed to participate in research;
what they were nervous about before
participating in the HSSP study; what
they did and did not enjoy while in
the study; and what they felt could

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011


be done to improve studies for children and to make children less nervous in the future.

pated in 7 focus groups. Focus group


participant characteristics are shown
in Table 1.

Data Analysis

Focus Group Findings

The 2 facilitators systematically transcribed the audiotapes and compared


them against the written transcript.
This method enabled errors in
understanding to be corrected. The
transcripts were then reviewed to
identify trends and patterns among
the focus group sessions. Using
NVIVO (version 7, QSR International
Pty Ltd., Doncaster, Victoria, Australia, 2006), data were then coded
and sorted independently by the 2 facilitators according to the recurring
trends and patterns. The 2 facilitators
then met to check codes. Discrepancies were discussed until the facilitators came to a consensus. Key
phrases were coded into the matrix
to allow for a more detailed understanding of the key themes identied
by the facilitators.20

Responses reached saturation after 5


focus group transcripts were analyzed.
A summary of focus group ndings is
shown in Table 2.

RESULTS
Demographics
In total, 35 individuals (average age
9.1  0.8 standard deviation) partici-

Perceived benets before participating in research. Participants were


most excited about participating in
a research study because of the incentive, a $30 gift card to a local sporting
goods store, they would receive upon
study completion. Children also
looked forward to being involved in
the study because of the tests being
conducted: I really had an interest
in that monitor that measures how
much energy you use and [I was
interested in] seeing what the swab
[for saliva analysis] looked like. Few
children were most excited about
trying the study snack that would be
provided.

Perceived barriers before participating


in research. Participants were primarily nervous about having their nger
pricked for the blood sugar reading:

Kafka et al 105
[I was nervous about] getting my nger pricked. I didnt know what it
would feel like. Some were nervous
about the snack they would have to
eat as a participant in the study: [I
was nervous] that I wouldnt like the
snack.

Perceived benets after participating


in research. Getting a gift card was
the highlight of participating in the
study, even after study completion.
Children also enjoyed the process of
being monitored during data collection: I liked knowing that I was
getting tested as that has never happened to me before and [I liked] putting the belt thing on and measuring
how much activity I did.

Perceived barriers after participating


in research. The nger prick remained the least enjoyable aspect of
the study after study completion (I
didnt like the nger prick because it
didnt make me feel good and I
didnt like the nger prick because it
kind of hurt), followed by eating
the study snacks: [I didnt like] having the snack and feeling bad avors
down my throat. Few children said
they enjoyed the saliva test the least:
I didnt like the saliva test because I
didnt like the [swab] in my mouth.

Cue to action to create readiness for


participating in research: improving
the research experience. The majority

Table 1. Participant and Focus Group Characteristics


Total, n (%) (n 35)
Sex
Male
Female
Age (y)
7
8
9
10
Prior participation in a research study
(excluding the HSSP study)
Yes
No

15 (43)
20 (57)
1 (3)
7 (20)
14 (40)
13 (37)

0 (0)
35 (100)
Focus group, n (%) (n 7)

Individuals in each focus group


2
3
5
6
10
HSSP indicates Healthy Snacking for Soccer Playing Kids.

1 (14)
2 (29)
1 (14)
2 (29)
1 (14)

of participants felt the study experience could be improved in the future


by changing the snack. Most wanted
a different healthful snack, with the
most popular suggested alternative
being fruit. Others felt the study
would be a better experience if they
did not have to have a nger prick or
if they got a larger stipend: more
dollars [that could be used] for any
place.

Cue to action to create readiness for


participating in research: reducing
barriers to participation. To reduce
trepidation for participating in research, most children felt that demonstrating the different aspects of data
collection before the study started
would help make other children less
nervous to participate in research in
the future: Show them doing the nger pricks and showing how it doesnt

106 Kafka et al

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011

Table 2. Summary of Focus Group Findings: Motivations for Taking Part in Nutrition
Research Within Context of the Health Belief Model for Behavior Change
Health Belief Model Constructs
Perceived benefits before participating in research
 Receiving a gift card
 Being tested (eg, accelerometer, saliva analysis)
 Eating the study snack
Perceived barriers before participating in research
 Being tested (eg, finger prick)
Perceived benefits after participating in research
 Receiving a gift card
 Being tested (eg, accelerometer)
Perceived barriers after participating in research
 Being tested (eg, finger prick, salivary collection)
 Eating the study snack
Health Belief Model Mediating Factors
Cues to action to create readiness for participating in research: Improving the
research experience
 Improving study snack
 Eliminating finger prick
 Increasing value of gift card
Cues to action to create readiness for participating in research: Reducing barriers to
participation
 Demonstrating data collection methods before data collection day
 Using distraction techniques during data collection (for finger prick and salivary
collection)
 Providing verbal reassurance during recruitment
Cues to action to create readiness for participating in research: Willingness to
participate in future research
 All children reported willingness to be in a research study again in future
 Some children would participate only if received financial compensation

hurt and Demonstrate things you


are going to do instead of just telling
them.
Children also offered suggestions
for making the data collection
methods more comfortable. Distraction techniques were the most common suggestion (When you are
doing the nger prick, you could
have something to squeeze in your
hand or hug something, During
the saliva test, ask them yes or no
questions so they wont really be focused on whats in their mouth,
and Just blow as hard as you can
and it [takes] your mind off the [nger] prick).
Other children suggested highlighting the positive aspects of the
study during recruitment: Tell them
its really easy and its fun. Children
also suggested providing reassurance
for aspects of the study participants
may be most worried about (The nger prick, I would just tell them it hurts

for one second and you might need


a band-aid) and ensuring the children
knew they didnt have to do anything
they didnt want to do on study day
(Tell them just dont do the nger
prick if they dont want to).

Cue to action to create readiness for


participating in research: willingness
to participate in future research. The
majority of children agreed that they
would like to be in a research study
again in the future. Some children,
however, said they would do so only
if they received nancial compensation. None said they would never
want to be a participant in a research
study again in the future.

DISCUSSION
Because children are considered vulnerable subjects, healthy children
may be more likely to be excluded

from research that is nontherapeutic.21 This study explored the perceptions of healthy children and their
involvement in research. A key nding was that healthy children appear
to perceive the same primary benets
of participating in research as children
with a disease or condition who are
involved in drug or treatment trials.
Both this study and the studies by
Fogas et al11 and McGuinness et al12
found that children are motivated to
participate in research primarily for
self-interest, such as for the money,
because they were interested in various tests being done in the study, or
to get different medical treatment.
Mower22 discusses the idea that, in
evolutionary psychology, there are
sex differences in moral interests or
values; justice is a primary value and
dominance a primary interest in
males, whereas care is a primary value
and empathy, fairness, and equality
are primary interests in females,
which suggests that females would
be more motivated by altruism to participate in research. However, in this
study, there was no observed sex difference, as both males and females
were primarily motivated to participate in research for self-interest, in
this case, the nancial incentive.
The use of nancial incentives in
both pediatric and adult research
arouses ethical concerns, especially regarding the potential for money to
inuence subjects to give informed
consent or assent with less regard for
potential risk involved in study participation.23,24 The focus group results
showed that the nancial incentive
to participate in the HSSP study was
the most common motivation for
children of all ages; however, it has
been found that children under 9
years of age do not have an
appreciation for the role of money in
society or as a reward for research
participation.25 This nding suggests
that, since nancial incentives were
found to be the most common motivation for study participation, the
use of this incentive should be carefully considered with all research
involving children as participants. A
2004 report from the Institute of Medicine by a panel responsible for
a review of the system of overseeing
pediatric research stated that research
institutions should adopt explicit
written policies on acceptable and

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011


unacceptable types and amounts of
payments related to research participation.26 However, the challenges
in developing explicit policies have
been documented, and there remains
a need for further empirical research
to support the development of guidelines and policies surrounding the
use of acceptable nancial incentives
for children.23
Although this study demonstrated
that healthy children perceive the
same primary benets of research participation as children with a disease,
there is no known research to date
that compares responses of children
with and without disease involved in
a trial. One potential difference is children with a disease may have a greater
degree of motivation to participate in
attempts to improve or slow a disease
process. Further nutrition research involving children with and without disease together in a trial may be of interest
to determine whether there are potential differences between these 2 groups.
The motivations for research participation reported by children are
congruous with those expressed by
parents of children who consented to
enrolling their children in research.
Parents reported doing so for personal
reasons: in an attempt to help nd
a treatment or a cure for disease, to
learn more about the childs condition, to advance knowledge about the
condition, or to improve access to
treatment.3-10 Understanding both
childrens and parents perceived
benets of research participation is
critical. Knowing that self-interest is
the primary reason children are enrolled in research suggests that recruitment should focus on highlighting the
personal benets for trial participation
for both children and their parents.
The focus groups also revealed that
children felt study investigators could
have done more to prepare them for
what they would encounter during
the study, as well as to ease the data collection, specically the nger pricks, on
the study day. Children wanted prestudy demonstrations of the procedures that would occur during data
collection. They also suggested the use
of distraction techniques to reduce anxiety during study participation. These
suggestions are consistent with developed pediatric psychology literature
on preparation for medical procedures.
This literature discusses preparation

techniques that may be used: encouraging trusting relationships, providing


information about what to expect, using imagery procedures, modeling,
systematic desensitization, distraction,
and positive reinforcement.27,28 A
literature review on strategies to
reduce anxiety before or during
nonurgent medical procedures or
outside of a medical center, however,
revealed limited results. Published
data focus on the use of child life
specialists to help children prepare for
surgery.29,30 Studies on the use of
distraction techniques in children
have focused on preoperative cases.
They have shown reduced reported
anxiety using alternative distraction
approaches,
including
music
therapy31 and the use of toys such as
videogames.32 Increasing childrens
readiness to participate in research by
demonstrating
anxiety-provoking
components of the study may be key
to minimizing nervousness about research participation and may thereby
increase enrollment. Additional research is warranted to better understand techniques that could help
reduce nervousness of children participating in nutrition research, which is
regularly conducted outside of a traditional medical clinic or hospital setting.
The majority of children who participated in the focus groups felt the
study could be enhanced by improving the study snack. They either preferred different healthful snacks or
they would have liked to choose
what they ate from a selection of
snacks. This nding suggests that the
snacks provided in the HSSP study
may not be snacks children would realistically eat prior to participating in
physical activity or throughout daily
activities. Before the study started,
the snacks used were tested for palatability in a population similar to the
children who participated in the
HSSP study. The tested snacks were adjusted based on feedback prior to their
use; however, they were not retested
after adjustments were made. Further,
the children who tested the study
snacks were not asked if they would
be likely to eat the study snacks if
allowed to choose from a variety of
healthful
snacks.
This
nding
suggests that thorough formative
research in nutrition studies is critical
to test food items for likelihood of
consumption as a regular part of

Kafka et al 107
a childs diet if the nutrition intervention is intended to be adopted outside
of a study setting.
The current study uses questions
similar to those used in a previously
administered study to elicit responses
regarding participation in research.11
Although this method has advantages, such as that ndings are salient
to experienced events versus a hypothetical study, it also has disadvantages, such that generalizability may
be reduced to other studies with different nutrition task demands, benets, and barriers. Using the questions
from this study to conduct focus
groups following other nutrition trials
involving children may help improve
the generalizability of the results.
Focus groups, rather than individual interviews, were the chosen
method for identifying patterns of attitudes, beliefs, and barriers toward
health behaviors among the population polled, as children had a shared
experience participating in the HSSP
study and because they were not discussing an especially sensitive topic,
so there was little reason to believe
they would be inhibited from answering questions honestly in a group setting. Further, it was cost effective
because the children were easily gathered in teams before a scheduled soccer
match. However, the focus groups
provide data from a limited sample
population, therefore they are not generalizable to a broader group of children. The focus group sizes in this
study were variable, with 3 of the
groups being small (2 or 3 participants
per group), and the age representative
of primarily 8- to 10-year-olds despite
the HSSP study including 7- to
10-year-olds, as only one 7-year-old
participated in the focus groups. The
sample used in this study was not representative of a more general population based on age, racial background,
and socioeconomic status, which further limits the ability to apply the ndings on a broader level. Additional
studies will be needed to conrm the
results of these focus groups.

IMPLICATIONS FOR
RESEARCH AND
PRACTICE
This research is benecial to a larger
population, as it is the rst to examine

108 Kafka et al

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011

the attitudes of healthy children


toward research study participation
and to do so using constructs and
mediating factors from the Health
Belief Model for Behavior Change.
Identifying and addressing perceived
barriers to and benets of research
participation and exploring ways to
encourage childrens readiness to participate in nutrition research is important as more nutrition and physical
activity research is undertaken, so
that optimal enrollment can be
achieved and this vulnerable population has a positive experience when
participating in research.
To continue to improve the understanding and design of research for
children in the future, the development of a validated survey to evaluate
childrens perceptions of being involved in research could be a valuable
tool. Further, qualitative research with
children who choose not to participate in research should be conducted.
This information will better help
determine perceived barriers for participation and explore suggestions to
encourage readiness to participate in
children who currently choose not to
enroll in research. More effective communication can then be established to
promote enrollment in nutrition
trials; thus, intervention studies can
be successfully conducted to help
improve the health of children, especially given current obesity trends in
younger populations.

and biologic products in pediatric


patients: Final rule. Fed Regist.
1998;63:66631-66672.
Barrera M, DAgostino N, Gammon J,
Spencer L, Baruchel S. Health-related
quality of life and enrollment in phase
1 trials in children with incurable cancer. Palliat Support Care. 2005;3:
191-196.
Harth SC, Thong YH. Sociodemographic and motivational characteristics
of parents who volunteer their children
for clinical research: a controlled study.
BMJ. 1990;26(300):1372-1375.
Van Stuijvenberg M, Suur M, de Vos S,
et al. Informed consent, parental awareness, and reasons for participating in
a randomized controlled study. Arch
Dis Child. 1998;79:120-125.
Sammons
HM,
Atkinson
M,
Choonara I, Stephenson T. What motivates British parents to consent for
research? A questionnaire study. BMC
Pediatr. 2007;7:12.
Hayman RM, Taylor BJ, Peart NS,
Galland BC, Sayers RM. Participation
in research: informed consent, motivation and inuence. J Paediatr Child
Health. 2001;37:51-54.
Tait AR, Voepel-Lewis T, Siewert M,
Malviya S. Factors that inuence parents decisions to consent to their childs
participation in clinical anesthesia
research. Anesth Analg. 1998;86:50-53.
Aby JS, Pheley AM, Steinberg P. Motivation for participation in clinical trials
of drugs for the treatment of asthma,
seasonal allergic rhinitis, and perennial
nonallergic rhinitis. Ann Allergy Asthma
Immunol. 1996;76:348-354.
Rothmier JD, Lasley MV, Shaprio GG.
Factors inuencing parental consent in
pediatric clinical research. Pediatrics.
2003;111:1037-1041.
Fogas BS, Oesterheld JR, Shader RI. A
retrospective study of childrens perceptions of participation as clinical research subjects in a minimal risk study.
J Dev Behav Pediatr. 2001;22:211-216.
McGuinness C, Cain M. Participation
in a clinical trial: views of children and
young people with diabetes. Paediatr
Nurs. 2007;19:37-39.
Barlow SE: Expert Committee. Expert
committee recommendations regarding the prevention, assessment, and
treatment of child and adolescent overweight and obesity: summary report.
Pediatrics. 2007;120(suppl 4):S164-S192.
Ogden CL, Carroll MD, Curtin LR,
McDowell MA, Tabak CJ, Flegal KM.
Prevalence of overweight and obesity

ACKNOWLEDGMENTS
This research was funded by the
California Raisin Marketing Board.
The authors thank Valerie Clark, MS,
RD (Tufts University), Laura Ficker
(graduate student), and Naomi Reyes,
MS (Tufts University) for their help
with the focus groups, audiotape transcription, and data coding.

REFERENCES
1. National Institutes of Health. Policy and
Guidelines on the Inclusion of Children in
Research Involving Human Subjects.
Bethesda, MD: National Institutes of
Health; 1998.
2. Health and Human Services regulations
requiring manufacturers to assess the
safety and effectiveness of new drugs

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

in the United States, 1999-2004.


JAMA. 2006;295:1549-1555.
Ogden C, Carroll M, Flegal K. High
body mass index for age among US
children and adolescents, 2003-2006.
JAMA. 2008;299:2401-2405.
Obesity and Overweight for Professionals: Health Consequences. Centers
for Disease Control and Prevention
Web
site.
http://www.cdc.gov/
obesity/causes/health.html. Updated
August 19, 2009. Accessed July 26, 2010.
Strecher VJ, Rosenstock IM. The
Health Belief Model. In: Glanz K,
Lewis FM, Rimer BK, eds. Health
Behavior and Health Education: Theory,
Research, and Practice. 2nd ed. San Francisco, CA: Jossey-Bass Publishers;
1997:41-59.
Sacheck J, Kafta T, Rasmussen H,
Blumberg J, Economos C. The impact
of pre-exercise snacks on exercise intensity, stress and fatigue in children. Med
Sci Sports Exerc. 2009;41(suppl 1):105.
Middlesex County, Massachusetts
DP-1. Prole of General Demographic
Characteristics: 2000. US Census Bureau Web site. http://lmi2.detma.
org/lmi/pdf/City_and_Town/Acton.pdf.
Accessed July 26, 2010.
Krueger RA. Focus Groups: A Practical
Guide for Applied Research. 3rd ed.
Thousand Oaks, CA: SAGE Publications; 2000.
Coleman DL. The legal ethics of pediatric research. Duke Law J. 2007;57:
517-624.
Mower D. Sex differences in moral interests: the role of kinship and the nature of reciprocity. J Theory Soc Behav.
2009;39:111-119.
Iltis AS, Matsuo H, DeVader SR. Currents in contemporary ethics: ethical
and practical concerns in developing
payment policies for research involving
children and adolescents. J Law Med
Ethics. 2008;36:413-418.
Bentley JP, Thacker PG. The inuence
of risk and monetary payment on the
research participation decision making
process. J Med Ethics. 2004;30:293-298.
Bagley SJ, Reynolds WW, Nelson RM.
Is a wage-payment model for research
participation appropriate for children?
Pediatrics. 2007;119:46-51.
Institute of Medicine. The Ethical Conduct of Clinical Research Involving Children. Recommendation 6.1. Washington,
DC: Institute of Medicine; 2004.
Routh D, ed. Handbook of Pediatric Psychology. New York, NY: Guilford
Press; 1988.

Journal of Nutrition Education and Behavior  Volume 43, Number 2, 2011


28. Wolchik SA, Sandler IN, eds. Handbook of
Childrens Coping: Linking Theory and Intervention. New York, NY: Plenum; 1997.
29. Brewer S, Gleditsch SL, Syblik D,
Tietjens ME, Vacik HW. Pediatric anxiety: child life intervention in a day surgery. J Pediatr Nurs. 2006;21:13-22.

30. Dreger VA, Tremback TF. Management of preoperative anxiety in children. AORN J. 2006;84:778-780, 782
786,788790.
31. Kain ZN, Caldwell-Andrews AA,
Krivutza DM, et al. Interactive music
therapy as a treatment for preoperative

Kafka et al 109
anxiety in children: a randomized
controlled
trial.
Anesth
Analg.
2004;98:1260-1266.
32. Patel A, Schieble T, Davidson M, et al. Distraction with a hand-held video game
reduces pediatric preoperative anxiety. Paediatr Anaesth. 2006;16:1019-1027.