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Serra-Payaetal.BMCPublicHealth2013,13:1000 http://www.biomedcentral.com/1471-2458/13/1000 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. Serra-Payaetal.BMCPublicHealth2013,13:1000 Page2of14 http://www.biomedcentral.com/1471-2458/13/1000 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 Serra-Payaetal.BMCPublicHealth2013,13:1000 Page3of14 http://www.biomedcentral.com/1471-2458/13/1000 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 Serra-Payaetal.BMCPublicHealth2013,13:1000 Page4of14 http://www.biomedcentral.com/1471-2458/13/1000 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 Serra-Payaetal.BMCPublicHealth2013,13:1000 Page5of14 http://www.biomedcentral.com/1471-2458/13/1000 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 Serra-Payaetal.BMCPublicHealth2013,13:1000 Page6of14 http://www.biomedcentral.com/1471-2458/13/1000 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. Serra-Payaetal.BMCPublicHealth2013,13:1000 Page7of14 http://www.biomedcentral.com/1471-2458/13/1000 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 Serra-Payaetal.BMCPublicHealth2013,13:1000 Page8of14 http://www.biomedcentral.com/1471-2458/13/1000 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 Serra-Payaetal.BMCPublicHealth2013,13:1000 Page9of14 http://www.biomedcentral.com/1471-2458/13/1000 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. Serra-Payaetal.BMCPublicHealth2013,13:1000 Page10of14 http://www.biomedcentral.com/1471-2458/13/1000 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

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informed of the purpose and the methodology of the study and are invited . Table 2 Contents of physical activity training for children, Personal knowledge games .. For collecting the resource use data and on the cost .. ACSM (American College of Sports Medicine): ACSM's Guidelines for Exercise.
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