S1 Protocol.

14 Pages·2013·0.34 MB·English

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STUDY PROTOCOL Open Access
Evaluation of a family intervention programme
for the treatment of overweight and obese
children (Nereu Programme): a randomized
clinical trial study protocol
Noemi Serra-Paya1*, Assumpta Ensenyat1, Jordi Real2,3, Iván Castro-Viñuales4, Amalia Zapata5, Gisela Galindo2,6,
Eduard Solé-Mir7, Jordi Bosch-Muñoz7, Jose Maria Mur4 and Concepció Teixidó6
Abstract
Background: Obesity is mainly attributedto environmental factors. In developed countries, thetime spent on
physical activity tasks is decreasing, whereas sedentarybehaviour patterns are increasing.
The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-
component intervention(Nereu programme) and compared it to counselling interventionsuch as a health centre
intervention programme for themanagement of children’sobesity.
Methods/Design:The study design is a randomized controlled multicenter clinical trial using two typesof
interventions:NereuandCounselling.TheNereuprogrammeisan8-monthintensivefamily-basedmulti-component
behaviouralintervention.Thisprogrammeisbasedonamultidisciplinaryinterventionconsistingof4components:
physicalactivitysessionsforchildren,familytheoreticalandpracticalsessionsforparents,behaviourstrategysessions
involvingboth,parentsandchildren,andlastly,weekendextraactivitiesforall.Counsellingisofferedtothefamilyin
theformofamonthlyphysicalhealthandeatinghabitssession.Participantswillberecruitedaccordingthefollowing
criteria:6to12year-old-children,referredfromtheirpaediatriciansduetooverweightorobesityaccordingthe
InternationalObesityTaskForcecriteriaandwithasedentaryprofile(lessthan2hoursperweekofphysicalactivity),
theymustliveinornearthemunicipalityofLleida(Spain)andtheirhealthcarepaediatricunitmusthavepreviously
acceptedtocooperatewiththisstudy.Thefollowingvariableswillbeevaluated:a)cardiovascularriskfactors
(anthropometricparameters,bloodtestandbloodpressure),b)sedentaryandphysicalactivitybehaviouranddietary
intake,c)psychologicalaspectsd)healthrelatedqualityoflife(HRQOL),e)cost-effectivenessoftheinterventionin
relationtoHRQOL.Thesevariableswillbethenbeevaluated4timeslongitudinally:atbaseline,attheendofthe
intervention (8 months later), 6 and 12 months after the intervention. We have considered necessary to recruit
100 children and divide them in 2 groups of 50 to detect the differences between the groups.
Discussion: This trial will provide new evidence for the long-term effects of childhood obesity management, as
well as help to know the impact of the present intervention as a health intervention tool for healthcare centres.
Trial registration: ClinicalTrials.gov, NCT01878994
Keywords: Obesity, Children, Physical activity, Nutrition, Behaviour, Health, Sedentary, Paediatric unit
*Correspondence:[email protected]
1NationalInstituteforPhysicalEducationofCatalonia(INEFC)ofLleida,
UniversityofLleida,PartidaCaparrellas/n,25191Lleida,Spain
Fulllistofauthorinformationisavailableattheendofthearticle
©2013Serra-Payaetal.;licenseeBioMedCentralLtd.ThisisanopenaccessarticledistributedunderthetermsoftheCreative
CommonsAttributionLicense(http://creativecommons.org/licenses/by/2.0),whichpermitsunrestricteduse,distribution,and
reproductioninanymedium,providedtheoriginalworkisproperlycited.
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Background hours/intervention) intensity interventions the most ef-
Obesity in children is one of the most important public fectiveones.
health a problem in the 21st century, as it is has been Thus, this increase on physical activity practice needs
voiced for years by the World Health Organization. It is to be linked to changes in other important habits such
considered the most common nutritional or metabolic as nutrition, psychological aspects and the behaviour of
disorder and the main non-contagious illness in devel- the nuclear family [17,19-21], the latter being even more
oped countries.The National Health Survey inSpain [1], necessary inpre-adolescentchildren[20,22].
in its three last editions [2003, 2006, 2010], has shown a These other factors can be responsible for obesity
continuous increase in overweight [18.2- 18.7- 19.2%] maintenanceandoneofthelimitingfactorsinchildhood
and obesity percentages [8.5- 8.9- 9.4%], in children be- obesityinterventions.
tween 2 and 17 years old. More recently, the results of Recent bibliographic reviews [7,14-18,21] show that
Aladinos’ study [2], indicated that 45.2% of children this is a growing research field but there are still ques-
between 6 and 9.9 years of age are either obese or tions to resolve, such as the high percentage of incom-
overweight. plete follow-ups, which make it difficult to assess the
Obesity is a complex and multifactorial cronical ill- long-term effectiveness of the programmes/interven-
ness, with its origin in a behavioural and environmental tions. In addition, paediatric units still lack effective
interaction [3], leading to an imbalance between energy tools totreat obesityinchildren.Inthissense, theNereu
intake and expenditure [4]. It usually begins in child- programme (NP) has been developed in order to give
hood or adolescence and it isconsidered a risk factor for paediatric units a tool to help them in the management
metabolic, cardiovascular and pulmonary diseases [5]. obesitylong-term.
We need to take also into account the psychosocial Theaim of this study is to evaluate the effectivenessof
problemsofobese child[5]andtheirlowerqualityoflife an intensive family-based behavioural multi-component
comparedtotheirhealthy-weightpeers[6]. intervention (NP) compared to counselling intervention
Due to its important health, social and psychological (CG; advice on physical activity and dietary healthy be-
consequences [7], the prevention and treatment ofchild- haviour) as a health centre intervention tool for the
hood obesity has become one of the leading priorities of managementofchildren’sobesity.
public health. It is critical to begin prevention during Secondary objectives are the evaluation of the effect-
childhood as childhood obesity tends to persist into iveness of the intervention changes in the following pa-
adulthood [7]; about 70% of obese children continue to rameters at short, medium and long term following the
beobese intotheiradulthood [8]. intervention referred toasbaseline:
Connely et al. [9] consider that physical activity at
moderate-to-high intensity is the principal factor to dis- a) Cardiovascularriskfactors: Anthropometric
tinguish between effective and ineffective childhood parameters(BMI,BMISDscore,waist-sizeindex
obesity prevention programmes. However, in childhood and waistcircumference),bloodpressure (diastolic
obesity treatment programmes, performing physical and systolicpressure) andbloodtests(LDL
activity 3 times per week was not enough to reduce adi- cholesterol, HDLcholesterol,triglycerides,glucose,
posity [10-12]. According to Trinh [13], focusing treat- insulin,TSHand cortisol).
ment of childhood obesity only in physical activity is not b) Physicalconditionevaluatedbyaphysical fitness
enough, as its relationship to body mass index (BMI) is test.
not clearly quantified. c) Sedentaryand physical activity behaviourand
Reviews from Atlantis [14], McGovern [15] and dietary intake.
Spruijt-metz [16] have shown that 12% -14% of the pro- d) Psychological aspectssuchasself-efficacyand
grammes treating childhood obesity that include physical self-concept.
exercise have a positive effect on the amountof adiposity. e) Health relatedqualityoflife(HRQOL).
Oude Luttikhuis et al. [17], after performing a systematic f) Cost-effectivenessoftheintervention inrelation to
review on the interventions to treat obesity in children HRQOL.
and youngsters, showthatthemosteffectiveprogrammes
are those which integrate different strategies in obesity Methods/Design
managementbesidesphysicalactivity.Theyemphasizethe Trialdesign
value of family interventions involving physical activity, The study design is a randomized controlled multicenter
nutrition and behaviour. Furthermore, in a meta-analysis, clinical trial over a period of 20 months (Figure 1) for
Whitlock [18] adds that intervention effectiveness de- overweight and obese children. They will be randomly
pends on the total length of the intervention, consid- allocated to study groups previous to participant’s re-
ering moderate (26–75 hours/intervention) to high (>75 cruitment. The study is children and family-based and
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16 Healthcare Paediatric Units
from 7Health Centres
nt nts Potential candidates who meet inclusion criteria according
e a
m p BMI z score and age from each Paediatricians
ol ci
r ti
n r
E a Randomization to groups
P
Confirmation of medical eligibility
Refuse to Excluded (not
participate Eligible inclusion criteria)
n
o Agree to
i
t participate
a
c
o
l
l
A
Counselling Group Nereu Programme
Baseline assessment Baseline assessment
n
s o CounsellingGroup Nereu Programme
h i
nt nt 8 months intervention 8 months intervention
o ve
m r
8 te
n
i
CounsellingGroup Nereu Programme
Measurementsend of Measurementsend of
intervention intervention
s
t
p n
u me
w- e CounsellingGroup Nereu Programme
o r
l u 6 months follow up 6 months follow up
Fol eas
m
CounsellingGroup Nereu Programme
12 months follow up 12 months follow up
Figure1Flowdesign.
includesan8monthinterventionofphysicalactivityses- researchers or HPU professionals blinded to the allo-
sions for children, family sessions for parents, behaviour catedstudygroup.
strategy sessions for children and parents, and weekend After the follow-up period, the children in the control
extra activities. Briefly, at least 100 obese children will group will be offered to participate in the next season of
be randomly allocated to either NP or CG. An assess- theNP.
ment will be made before the intervention, 8 months
later (at the end of the intervention), and 6 and Participants
12 months of the follow-up period. All measurements Eligible participants will be children aged between 6 and
will be taken at the same research unit and by trained 12 years old who are overweight or obese according the
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International Obesity Task Force Criteria (IOTF) defined Samplesize
by Cole et al. [23]. They are sedentary (less than 2 hours The aim of the research team is to recruit 50 subjects
per week of physical activity outside school hours), live per group, computing a total of at least 100 participants.
in or near the municipality of Lleida (Spain) and their The calculation of the sample size takes as its primary
healthcare paediatric unit (HCP) has previously accepted outcomeinterventionefficacy -the reductionofBMISD
tocooperate inthis study. In addition,at leastone ofthe scores after the intervention, as specified in a published
parents or guardians of the child must accept to actively meta-analytic review of trials [24]. The sample size was
participateinthestudy. calculated in order to detect one BMI SD scores reduc-
Exclusion criteria are: a) medical co-morbidities, such tion (effect size=0.60 [24]), according an 80.0% statis-
as Cushing disease, hypotiroidism, cardiovascular dis- tical power, 5% significance level to detect differences
eases or other serious chronic illnesses; b) use of medi- between groups with two independent samples. It is as-
cation that might have an effect on weight loss or sumeda20%dropoutrate wasestimated.
adaptations to exertion; c) previous enrolment in other
obesity treatment interventions; d) regular participation Ethicalaspects/Considerations
inphysical exercise programsinthe past6months. The study will be carried out according to the principles
ofthe“DeclarationofHelsinki”andsubsequentrevisions
[25] and to the Guidelines for Good Practice in Primary
Randomization
Care Research of the IDIAP [26]. This protocol has
On a first phase, professionals of the HCP in Lleida are
been approved by the Clinical Research Ethics Commit-
informed of the purpose and the methodology of the
tee (CEIC) of the Primary Care Research Institute
study and are invited to participate in it. Sixteen HCPs
(IDIAP) Jordi Gol. The study methods are in agreement
acceptedtocooperateinthisstudy.EachHPUisrespon-
with the CONSORT guidelines for reporting rando-
sible for the recruitment of participants and for the
mizated trials [27].
checking of their eligibility. Randomization will be cen-
tralized at the Primary Care Research Institute (IDIAP)
Intervention
Jordi Gol in Lleida. Each cooperating healthcare paediat-
Nereuprogramme
ric unit (HPU) will provide a random list of their
The NP is an 8-month intensive family-based behav-
patients/children fulfilling age and BMI SD scores inclu-
ioural multi-component intervention (from October to
sion criteria according to the data from their health clin-
May, that is, an academic year), consisting of 4 com-
ical records. These eligible children will be randomly
ponents (Table 1): (a) physical activity sessions for chil-
assigned to one of the study groups. Randomization will
dren, (b) family theoretical and practical sessions for
insure that patients are distributed to the 2 groups
parents,(c)behaviourstrategysessions,thatinvolveboth
homogenously in terms of age and gender. Group homo-
parental and child participation and (d) weekend extra
geneity with regard to age will be assured by stratified
activities.
randomization according to the age group: 6,7,8,9,10,
The whole intervention will take place in 3 different
11,12yearsold(7groups)ineachHPU(16HPU).
school centres and health care centres, which have been
recruited especially for the intervention and with a stra-
Recruitmentstrategy tegic localization around the city, in order to facilitate
Next, each HPU will phone/contact eligible families and their accessibility. The children’s physical activity ses-
will invite them to participate in the study. At that point sions will take place using the sport equipments of the
participants will be informed about their study/case school, the theoretical sessions for parents at the same
group. HPUs will recruit participants consecutively and school or at the health care centre next to the school,
on an alternate list mode basis, i.e. once they have re- and the behaviour strategy sessions will be performed in
cruited one eligible child from the intervention group both places. Parents’ and children’s sessions will be per-
list, they move on to recruit another participant from formed simultaneously in order to facilitate their attend-
the CG list. Families of eligible children that accept to ance. All intervention groups will have a maximum of
participate will be referred to their healthcare paediatric 15childrenandparents.
unit office for anin-depth explanation, followed by a The4structuredcomponentsare:
medical assessment (basic exploration and blood test to
check for inclusion and exclusion criteria). Children’s a).Physicalactivity sessionsforchildren
assent and written parental informed consent will be ob- Thephysicalexerciseprogrammeofferedtochildren
tained from children who fulfil the inclusion criteria and willconsistof90 sessions(3sessions perweek,each
with no exclusion criteria. The family will be finally in- lasting60minutes).Themainaim ofthesessions is
cluded inthe study. toenhanceaphysical activebehaviour,tolookfor
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Table1Contentsoftheassemblyofchildren,thefamilytheoreticalcounselingsessionsforparentsandthebehavior
strategiessessionsforboth
Target/term Parents/children Parents’sessionscontents Children’sassembly
Phase N Behaviorchangestrategy contents
Explainingexpectations Presentingtheprogramme WhatisNereuProgramme?
1 Informationonhealth Understandingtheexpectations
oftheparentsatthebeginning Whatdoyouwanttoknow?
componentsoftheprogramme
oftheNereuProgramme
Informationabouthealthyfood Reflectingonthecurrentdiet
2 Benefitsofhealthyfood
Barrieridentification andhealthyfoodbenefits
1(OstctToebremr-December) C(Aotntecinetniocina)tion 3 Informationonoutcomes MimapkoinrgtanthceemofaPwAareofthe Winhsyposhrto?uldwetakepart
Gettinginformed
Provideinformationabout Knowingthebehavioursandactions Let'sgotoeathealthy
4
healthierdiet thathelpusimproveourdiet andfunny!
Provideinformationabout Becomingfamiliarwiththeirlifestyle
5 HowcanIgototheschool?
healthierbehaviour andhowtomakeitmoreactive
Explaininghowthe
6 programmeaimstoencourage Settingshort-termgoals (behaviourstrategysessionI)
healthierlifestyles
Understandingandknowingeat
7 Instructionsaboutnutrition Thetrafficlightgame
quantities
Waysinwhichtheycanachieve Becomingfamiliarwiththeir
amoreactivelifestyle/Identifying availabilityandrequirementsin Familyphotography!!Which
8 barrierstoparticipation ordertobemorePA.Whatwe sportwillyouTakepartin?
Self-monitoringofexistingPA shouldbedoing!
Provideinformationabout Whatdoweknowabout
9 Mythsrelatedtonutrition
healthiereating nutrition?
Usingdifferenttoolstobecome Theweatherisgood,
10 Encouraginghealthierlifestyle moreactive let’sgoandhavefun!!
2ndTerm
Modelation
(January-March) Givingoptionstoeatonspecificdays
Becomingaware (Retention) 11 Overcomespecificbarriers (Christmas,restaurants…) Ticket-aaaa!!!Eatingoutside!!
Behaviourmodificationstrategies Wherearewegoing
12 Socialsupportandchange
day-to-day nextweekend?
13 Provideinstructionsabout knowledgeabouthowtointerpret Let’sgotobuy!
healthierfood advertisingandhowbuyfood
Providefeedbackon Waysinwhichtheycanincorporate Whydoweusethe
14
performance PAintotheirlifestyle. elevator?
Encouragementandsetting
15 goalsonPAandnutrition Settingmedium-termgoals(behaviourstrategysessionII)
Maintainingbehaviourstrategies
Provideknowledgeabout
16 Learningtomakeabalancedmenu Howdoabalancedmenu?
healthiereating
Autonomy
(Reproduction) Specificencouragement
17 RelationbetweenPAandfoodintake Burningsweets!
Decisionalbalance
3rdTerm(April-Mai)
Committingand 18 Self PAevaluation EvaluatingtheimplementationofPA Howactivearewe?
keepingup Evaluation 19 Self-Dietevaluation EvaluatingtheimplementationofDiet Howwellyoueat?
(Motivation) EncouragingPAandnutrition Keepingupmediumandlong-termbehaviour
20
Maintenancebehaviourstrategies (behaviourstrategysessionIII)
Closure 21 Enjoyingahealthydaytogether ClosingParty
Encouragingactivebehaviourin
1eachterm 3weekend – anexperientialmannerand 3extrafamilyphysicalactivities:Ski,FCBarcelona,Aquaparty
extraactivities
socialsupport
greater enjoymentduringphysicalactivitytasksand Allsessions areplannedtobeperformedina
meet andpractisenewsportsandgamesinorderto friendlyuncompetitiveatmosphereandadaptedto
keeppractisingthem foralong time. theparticipants’needs,because motivating and
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encouragingobese childrentobephysicallyactive Table2Contentsofphysicalactivitytrainingforchildren,
cannotbeachievedfollowingthe sameapproachas familytheoreticalandpracticalsessionsandbehaviour
fornormalweight children[28].Obese children are changestrategies
physiologically differentfrom thosewhoare normal Term Childrenphysicalactivitysessions
weight,and they alsohavesignificant emotional Personalknowledgegames
differences[29].Inthat sense, thesessions have
Interactiongroupactivities
beenplannedbyspecialistswith atleast4yearsof 1stTERM(October-December)
Collaborationgames
experience inphysical activity with overweight and GETTINGINFORMED
Traditionalgames
obese childrenand followingthephysicalactivity
guidelinesforchildren[30-32].Allthesessions will Balance
beperformed bytwocoacheswhohavethe sport Differentkindsofadaptedsports
withoutcompetition
sciencedegreewith specific knowledge and
experience insporttreatmentforchildrenwith Gameswithalternativeequipment
2ndTERM(January-March)
overweight and obesity andwhohavealsoattended BECOMINGAWARE Aerobicgames
thespecificNereucourse.TheNereu coursehas Jointmobility
beenaddressedspeciallytoteach and helpcoaches,
Strengthgames
nursesand physical activity professionalsbefore
Motorandphysicalabilities
starting withthe intervention, with specificcontents
Aerobictasks
aboutobesitymanagement.
3rdTERM(April-Mai)
Allphysicalactivitysessions havea similar structure COMMITTINGANDKEEPINGUP Strengthexercise
butdiffer intheir contents.Sessionshaveafour-part Differentkindsofsportsandactivities
structure:assembly,warm-up,workoutandcool Outdoorsportsandgames
down periods.Duringtheassembly,the coach
explains theday’strainingtask,attemptstomotivate
childrenand introducescontentsrelatedtohealth
behaviourbasedonbehaviourchange strategies. The oneselfandmovinginorderforchildrentogetrid
assembly’scontents(Table1)arethesameasthe graduallyoftheirfearandreluctancetosports.The
family theoreticaland practicalsessions’contentsfor cool-downperiodiscomprisedbyrecoveryexercises
parents,but taught inaplayfuland experimental andstaticstretchingallowingparticipantstorecover.
atmosphere.Teaching the samehealthbehaviour Inaddition, each session fromtheworkoutparthas
contentsandonthe sameday andatthesame time beenplannedtobeamoderate-high intensity
tobothparentsand childrenlooksforan activity.Inthat sense, onesession every twoweeks
improvementintheeffectivenessofthese contents ineach centrewillberecorded byanaccelerometer
and theirapplicationathomebythe familyunit. and heart ratemonitor andfollowedwith an
Afterwards,duringthe warm-up part,dynamic assessment inordertobesurethat childrenfrom
activities suchaswalkingor joggingwillbe the3PAcentresfollow andreach thesame
performed atlowintensitieslooking fortheir indicationsinterms ofintensity.
activationbeforethe mainpart.Themainpart of
thesession(workout)isprimarilyfocusedonbeing b).Familytheoreticaland practicalsessions forparents
physicallyactive,but asoverweight and obese Thefamilyprogramme consistsof21 theoreticaland
childrengenerally arenotespecially fitandtend practicalcounsellingsessions with adurationof
bothtobesedentaryandtend tohavehadpoor 60minuteseach. Thesessions willbeingroupand
experiences withsport[33],exerciseswillbe willtakeplaceonce aweekatthesametimeastheir
plannedinshortperiodsofduration suchas4– children’ssessions,giving the family theopportunity
5minutes ofmoderate-highintensityactivities toexchangeexperiencesand establish shared
intersectedbyperiodsoflowintensity.Shortbouts compromiseslater athome.
ofintermittentexerciseare consideredmost Thesessions willbe carriedoutbytrainednurses
appropriateforthispopulation[34].Thesessionsare and physical activity educationprofessionalsskilled
alsodesignedlookingfortheirenjoymentthrough inmultidisciplinarybehaviourincluding physical
practisingandlearningdifferentkindsofsports, activity,nutritionand healthybehaviours(Table1).
activitiesandabilities.Trainingtaskswillbemainly Theoverallfocusofthe parental sessions istohelp
aerobic,butstrength,jointmobilityandbalancewill familiestomakebetterhealthybehaviourchoices
bealsoincluded(Table2).Thesehavebeenplanned mainlyinterms ofphysical activity andnutrition
accordingto3essentialpillars:playing,enjoying insidethefamilyunit.
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c).Behaviourstrategysessions,involvingchildrenand squared (m2) height and standard deviation score (BMI
parents SD score) will be determined from the LMS method
Thethreebehaviourstrategiessessionsforparents [40]. Waist circumference (WC) will be measured in
and children, oneeachterm,havebeen plannedto centimetres with an anthropometric tape (precision:
reinforcetheacquisitionof healthierphysicalactivity 0.1 mm), placed horizontally at the level of the max-
and eatinghabitswithin thefamily inamore imum abdominalprotrusion at the end of agentle expir-
experimental andpracticalmanner(Table1). ation [30]. Waist-to-height ratio (WHtR), will be
Thecontentsofthefamilytheoreticaland practical calculated aswaist circumference(cm)/height(cm).
sessions,thebehaviourstrategies sessions aswellas Triceps and subscapular skinfold thickness will be
theassemblyofphysical activity sessions,are measured at the right side of the body with the child
plannedmainly according tothe Social Cognitive standing up, with a Holtain skinfold calliper (Holtain,
Theory(SCT)ofBandura[35],andthe guidelines of Crymych, United Kingdom) to the nearest 0.2 mm. Tri-
severalinstitutions [32,36-38]. ceps skinfold is a vertical fold measurement performed
on the posterior midline of the upper arm, half way be-
d).Weekend extraactivities tween the acromion and the olecranon processes. Sub-
Additionally,threeextraweekendfamily physical scapular skinfold measurents will be taken about 20 mm
activities (e.g.skior water party) willbeorganized, below the tip of the scapula diagonally (at 45º angle to
oneeachtermfollowingthe schoolcalendar,in the lateral side of the body). Both skinfold measure-
ordertoencourageand achievethismore active ments will be performed with the arm held freely to the
behaviourinanexperiential way(Table1). side of the body. Waist circumference and skinfold mea-
Participants’friendsorrelativeswillbealsoinvited surements will be done in order (not consecutively; ro-
totakepart intheactivities,looking fortheirsocial tating sites) andrepeated threetimes.
and familialsupport.Atthesametime,plansare in
placeto helpthem toachievethe minimum Bloodpressure
recommendationsof60minutesadayofmoderate- Blood pressure assessment will be performed at the level
vigorous physicalactivity[39]. of the brachial artery of the dominant arm using an au-
tomated (i.e. oscillometric) device (Omrom) with chil-
Counsellinggroup dren in a relaxed sitting position, after 3 minutes of rest.
Each family will be offered 8 individual monthly 10- Measurements will be taken in duplicate and the last of
minute-duration meetings. These sessions will take place both measurementswillberecorded.
at the paediatrician’s office and will be delivered by the To determine hypertension, the normative values from
child’snurseor/andpaediatrician. Spanish children published by Fernández-Goula, et al.
The sessions’ contents will be about tips for the pro- [41]willbeused.
motionof healthyeatingandphysicalactivityhabits.
Bloodtests
Measurements With the participants in the sitting position, blood sam-
As the intervention is principally focused on a family- ples will be drawn by venipuncture after an overnight
based behavioural multi-component intervention for fast. These samples will be used to assess cholesterol
children’s obesity, both children and parents will be (LDL,HDL),triglycerides,glucose,insulin,TSHandcor-
assessed. The main measure parameters are described in tisol levels. Blood samples will be analysed with an auto-
Table3. mated method at the laboratory of the Hospital
Measurements will be assessed before and at the end UniversitariArnaudeVilanova,inLleida.
of the intervention, and 6 and 12 months after the end
ofit. Physicalcondition
To evaluate physical activity and fitness levels, children
Children’soutcome will perform the ALPHA fitness test battery [42]. The
Anthropometry ALPHA fitness test was specially created to assess the
Anthropometric parameters will be measured using health-related fitness status in children and adolescents
standard practice: weightwillbemeasuredtothenearest within the European Union. The physical measurements
0.1 kg using an electronic scale (Tanita Model SECA of the ALPHA fitness test that will be measured from
214, Hamburg, Germany) and height (Ht) to the nearest the children are: handgrip strength, standing long jump
of 0.1 cm with a stadiometer (Seca 214, Hamburg, and 4×10m shuttle run test. Procedures will follow the
Germany) with children lightly dressed and barefoot. standard guidelines indicated in the test manual [42]. To
The BMI will be calculated as weight (kg) divided by measure their aerobic capacity, the 6-minute walk
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Table3Measurements
Aim NereuandCounsellinggroupmeasures
Children Parents
Cardiovascularrisksfactors Anthropometry Weight WeightandHeight
Height
BMIzscore
Waistcircumference
Waist-sizeindex
Tricepsskinfold
Subscapularskinfold
Bloodpressure Diastolicandsystolicpressure NOTanalysed
Bloodtest Cholesterol(LDL,HDL),triglycerides,glucose,insulin,TSH NOTanalysed
andcortisol1
Physicalcondition Physicalcondition ALPHAtestset[42]
Behaviours Physicalactivity Seven-daysAccelerometry InternationalPhysicalActivity
QuestionnaireIPAQ[74]
Sevendaysrecallphysicalactivityquestionnaire(PAQ-C)[46]
Nutrition 24hdietaryrecall(x3days) Frequencyconsumption
(CFCA–adultsversion)
Frequencyconsumption(CFCA–childrenversion)
Psychologicalaspects Physiological,physical Physicalactivityself-efficacy[64] Health-specificself-efficacy[82]
andcognitive
Physicalself-concept(MIFA)[66]
Body-image:FigureRatingScale[67]
Physicalactivityenjoyment(PACES)[69]
Healthrelatedquality HRQOL PedsQL4.0[70]
oflife
Healtheconomicdata Cost-effectiveness CHU9D[73] EQ-5DEuroQolGroup[84]
Modifiersvariable Pubertalmaturity Tannerpubertalstage[88]
Socio-economicaland SomequestionsfromdeNationalHealthySurveyforchildren[89]andforparents[90]
demographicparameters
Adherence Attendancelog
Satisfaction Survey
1themeasurementwillbeundertaken2times:atbaselineandattheendoftheintervention.
testwill be used [43]. This test has been validated and EEUU). Age and gender specific cut-off points will be
hasshown reproducibility inobese children[43]. used to categorize behaviours into sedentary, light, mod-
erate and vigorous intensity activity [44]. Before its
Sedentaryandphysicalactivitybehaviours placement, a researcher will give oral and written infor-
Sedentary and physical activity behaviours will be mation about the procedure to the children and family.
assessed by means of a) the objective measurement of Families will be given a contact telephone number in
physical activity levels during seven days and b) the fill- caseofproblemsduringtheperiod.
inginofa self-reportactivityquestionnaire. Additionally, on the day of the accelerometer is re-
The objective measurement of physical activity level moved, children will fill out the Spanish version [45] of
will be done using ActiGraph GT3X+accelerometers the Physical Activity Questionnaire for Children (PAQ-C)
(ActiGraph, Pensacola, EEUU). Accelerometers will be [46]. This is a self-administered questionnaire that as-
worn by participants all day for eight consecutive days; sesses physical activity levels in children during the last
however data from the first day will be discarded for 7 days ofthe school year [46]. The PAQ-C is one of the
analysis. Accelerometers will be placed on a small elastic most widely used questionnaires of physical activity level
belt and positioned on the waist. Data will be collected assessment and its internal consistency and validity for
and stored in 30-second epochs and the mean activity children has been well established [47-50]. The PAQ-C
counts per minute will be calculated and analyzed with providesasummaryphysicalactivityscorederivedfrom9
ActiLife 6.0 software application (ActiGraph, Pensacola, items,eachscoredona5-pointscale,whichisdesignedto
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collect children’s information about different physical ac- active. It is the Spanish version of the physical activity
tivities and moments: (1) spare time activity, (2–8) phys- enjoyment scale [66]. It is a questionnaire composed by
ical education, recess, lunch, right after school, evening, 5 items, especially created for children in order to know
weekends,anddescribes-you-best,(9)takethemeanofall their intention to be physically active after school. The
days of the week. Questionnaires will be analysed using response scale is a Likert scale ranging from 1 (strongly
thescoringofthePAQmanual[51]. disagree)to5(strongly agree).
Body image will be assessed using the Body Figure
Dietarybehaviour Perceptions by Collins [67]. This instrument is useful to
To assess and monitor the dietary status of participants, investigate body figure perceptions and preferences
a dietary 24 h-intake-recall for three days and an eating among young children [67]. This measure consists in
frequencyquestionnairewillbeperformed. seven gender-specific line drawings of increasing size, la-
The dietetic record will be done for three days, in belled from 1 (thinnest figure) to 7 (heaviest figure).
which the families will annotate what the child has Thereisa specificfigure forboys andgirls.
eaten during these days. It will cover two weekdays Evaluation of the physical activity enjoyment will be
and one weekend day, and later a nutritionist will measured according to the Spanish version [68] of the
help them to interpret their annotations and power as physical activity enjoyment scale (PACES) [69]. The
recorded in the program by means of the quantitative questionnaire consists in 16 items rated from 1 (strongly
dietary diary proposed by Burke, as shown by Martin- disagree) to 5 (strongly agree). The PACES is for a single
Moreno [52] revisited and updated by Willet [53,54]. enjoyment factor that can be negative or positive. The
Families will be individually taught how to fill out the results found by Moreno [68] revealed that the scale is a
dietary 24 h-intake form, before they carry it out at valid and reliable tool to measure sport enjoyment in
their own home. Spanishpopulation.
Ontheotherhand, childrenwillalsocomplete theeat-
ing frequency questionnaire CFCA [55]. The question-
Healthrelatedqualityoflife
naire consists of a list of nutrients or group of nutrients.
The HRQOL for children and parent proxy-report will
Children will be asked to indicate the intake frequency
be determined by the Paediatric Quality of Life Inven-
(daily, weekly or monthly) of each component of the list.
tory (PedsQL4.0) [70]. The PedsQL 4.0 is one of the
This may be considered as a report card on the overall
most widely used measures of HRQOL in children and
quality of diet consumed. However, if the information is
adolescents aged 2 to 18 and have proven its validity in
combined with quantitative data about mean portions,
clinical and population samples [70-72]. It has 4 generic
the assessment could be semi-quantitative [56-58]. This
scales (Physical, Emotional, Social, School) and consists
method has already been used in longitudinal nutri-
of 23 items applicable for healthy school, as well as
tional studies in children [59,60] and to assess eating
paediatricpopulations.
patterns in children [61]. Both questionnaires are in-
cluded in the diet assessment survey developed by
Burke and have been performed in longitudinal studies Healtheconomicdataforchildren
of large populations of different ages [62]. The combin- TheChild Health Utility 9D (CHU 9D) [73] will be filled
ation of both methods has also been applied to the out by all the children in order to assess the cost-utility
assessment of eating patterns in Spain [63]. Both ques- of the intervention. The CHU 9D is a validated measure
tionnaires will be conducted by a trained/experienced of paediatric health-related quality of life. It has been
interviewer. specifically developed for use with children aged 7 to
11 years and contains 9 dimensions, each with 5 levels
Psychologicalaspectsandphysiologicalfactors and it is designed to be self-completed by children. The
The physical activity self-efficacy for children [64] will CHU 9D will be administered at baseline, at the end of
be used to provide a self-report of their PA self-efficacy. the intervention (8 months later of the baseline), 6 and
The scale is a specific Spanish scale that consists in 12 12monthspostintervention.
items and a dichotomous scale (yes or no) will be used The present questionnaire will allow for aprospective
instead of the five-point scales commonly used for this economic evaluation alongside the trial with the aim of
type of instruments in order to facilitate their under- estimating the cost-effectiveness of the NP intervention
standing to children [64]. The Cronbach alpha con- versus theCGintervention.
sistencyis.733 andtest-retest reliabilityis.867[64]. For collecting the resource use data and on the cost
The physical self-concept of children will be measured linked to the NP and CG, structured observational re-
with the physical self-concept scale (MIFA) by Moreno search methods, interviews and surveys in a sample of
[65], as a predictor of the intention of being physically childrenwillbe conducted.
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Parents’outcome The fill out analysis of the questionnaire will follow the
Anthropometricparameters user’s guide [87]. As for children, the questionnaire will
Parents’ weight and height will be measured during the be administered at baseline, at the end of the interven-
children assessment appointments, following the proce- tion (8 months later of the baseline), 6 and 12 months
dures previouslyindicated. post intervention.
Information on resource use and on the cost associ-
Sedentaryandphysicalactivitybehaviours atedtothepartoftheprogrammeforparents(economic
Parentalsedentaryandphysicalactivitybehaviourswillbe evaluation) will be also collected using the same struc-
evaluated using the short 7-day-recall self-administered tured asforchildren.
Spanish version [74] of the International Physical Activity
Questionnaire (IPAQ) [74,75]. The IPAQ is one of the Modifiervariables
most widely used questionnaires of physical activity level It has been shown that pubertal development, socio-
assessment and its reliability and validity for adults has economic anddemographicparameters,thedegreeofsat-
been previously established [76]. The short IPAQ allows isfaction and other factors could modulate the outcome.
to compute a total score of the duration (in minutes) and Forthatreason,apartfromoutcomemeasurements,dur-
frequency(days)ofsedentary-intensity,walking,moderate- ing the study, the following control information will also
intensity and vigorous-intensity activities. Guidelines for berecorded.
dataprocessingoftheInternationalPhysicalActivityQues-
tionnaire[77]willbeusedtoanalysethesequestionnaires. Pubertal stage Pubertal stage will be assessed by the
paediatrician using Tanner criteria [88] at baseline, at
Dietaryintake the end of the intervention and during the follow-up
To assess and monitor parents’ dietary status, the adult appointments.
versionoftheeatingfrequencyquestionnaire(CFCA)[55]
will be administered. The main difference between the Socio-economic and demographic parameters To
adult and the children version is that parentalingestion of control the participants’ sample for these parameters, a
drinkscontainingalcoholwillalsoberegistered[78,79]. 10 item-questionnaire has been created. Some questions
This questionnaire has been used previously in longi- have been selected from the National Healthy Survey for
tudinal dietary studies and in studies relating eating pat- children [89] and for parents [90], while some other
terns andbiologicalparameters inadults[80,81]. extra questions have been designed specifically for the
intervention. Briefly, all these extra questions and all the
Psychologicalaspects questionnairesfortheinterventionhavebeensatisfactor-
To assess the nutrition and physical exercise self-efficacy ily implemented in a pilot trial, with a similar sample of
in parents, the health-specific self-efficacy scales will be childrenand parentsduringthe last edition of theNereu
used [82]. The test for the nutrition and physical exer- programme.
cise part has been created following the same semantic
structure: “I am certain that I can do xx, even if yy (bar- Adherence To control adherence rate a registerof chil-
rier)” [83]. The internal consistency (Cronbach’s alpha) dren’s and parent’s attendance to sessions will be carried
for the nutrition self-efficacy scale was alpha=.87 and out. To consider that attendance has been satisfactory
forthe exercise self-efficacy scaleitwasalpha=.88[82]. each children/parent should attend at least 80% of the
scheduled sessions. Those that do not attend the 80% of
Healtheconomicdataforparents the sessions will be excluded of the per protocol
The EQ-5D [84] from the EuroQol Group will be filled analysis.
out by all the parents to measure the cost-utility of the
intervention. The EQ-5D descriptive system comprises Degree of satisfaction At the end of the intervention,
the following 5 dimensions: mobility, self-care, usual ac- children and parents will also fill out a satisfaction sur-
tivities, pain/discomfort and anxiety/depression. Each di- veyabout theinterventionandthe coaches.
mension has 5 levels: no problems, slight problems,
moderate problems, severe problems and extreme prob- Economicevaluation
lems [85]. The EQ-5D also has the EQ visual analogue The economic evaluation analysis of the cost data, the
scale (EQ VAS). The EQ VAS records the respondent’s CHU-9D for the child and the EQ-5D for the parent
self-rated health on a vertical, visual analogue scale questionnaire data and the cost-effectiveness analysis
where the endpoints are labelled ‘Best imaginable health will be conducted according to the current practice
state’ and ‘Worst imaginable health state’ [85]. The EQ- methods for conducting economic evaluation. The pri-
5D has demonstrated a reliability of 0.86 to 0.90 [86]. mary cost-effectiveness outcome will be the percentage