Homs et al. BMC Pediatrics (2021) 21:246 https://doi.org/10.1186/s12887-021-02697-x STUDY PROTOCOL Open Access Family-based intervention to prevent childhood obesity among school-age children of low socioeconomic status: study protocol of the FIVALIN project C. Homs1,2, P. Berruezo1, G. Según1, L. Estrada3, J. de Bont4,5,6,7,8, J. Riera-Romaní2, E. Carrillo-Álvarez9, H. Schröder5,10, R. Milà9 and S. F. Gómez1,11* Abstract Background: Childhood obesity represents a global public health crisis: the number of obese children and adolescents (aged 5–19 years) worldwide has risen tenfold in the past four decades. The vast majority of overweight and obese children live in high-income countries, and low socio-economic status (SES) is a significant risk factor. Family Based Interventions (FBI) have demonstrated positive results in preventing obesity, although these results are strongly influenced by SES. Moreover, we still poorly understand how FBI can determine a positive trend in weight status in low-income communities. Therefore, there is an urgent need to define and evaluate innovative and multi-target projects to reduce obesity risk behaviors and health inequalities and the present study aims to present the study protocol of FIVALIN a FBI that pretends to achieve this goal. Methods: We will conduct a quasi-experimental design within 60 Community Child Centers (CCC) in Barcelona metropolitan area. Each cluster (CCC) will be assigned by convenience to the intervention and control groups. For the whole study, a total of 810 children aged 8–12 years and 600 parents will be recruited during 3 consecutive editions (1st – 2019/2020; 2nd – 2020/2021; 3rd – 2021/2022) of 10 months each. The action is a regular multicomponent health-promotion intervention targeting children, families, and CCC. All activities are based on the Motivational Interviewing (MI) approach and will focus on promoting good dietary habits, physical activity, appropriate screen time and sleep duration, and psychological well-being. The control group participate in a unique workshop on general awareness of healthy lifestyles for families. We will perform a comparative analysis of the evolution of weight status, healthy lifestyles, and socioeconomic variables, between the intervention and control groups. Discussion: There is a need for more evidence on how to target and evaluate holistic interventions in low SES families. Our multi-targeting intervention for obesity prevention tackles risky behaviors that go beyond diet and physical activity (PA). Therefore, future interventions can effectively promote all the behavioral domains that determine trends in the weight status. * Correspondence: sgomez@gasolfoundation.org 1 Gasol Foundation, Sant Boi de Llobregat, Spain 11 GREpS, Health Education Research Group, Nursing and Physiotherapy Department, University of Lleida, Lleida, Spain Full list of author information is available at the end of the article © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Homs et al. BMC Pediatrics (2021) 21:246 Page 2 of 14 Trial registration: ISRCTN Registry: ISRCRN12682870. Registered 9 July 2020. Retrospectively registered. Protocol version: 30 April 2021, version 5. Keywords: Pediatric obesity, Primary prevention, Low-income population, Health status disparities, Healthy lifestyle Background factors, such as food advertising and marketing [25]; ii) Pediatric obesity is considered one of the most serious community factors, like neighborhood [26] (demon- public health issues of the twenty-first century [1]. In strated in the Spanish context) [27]; and iii) individual Spain, there is a special concern due to the high preva- lifestyles factors, such as daily PA [28]. However, family lence of overweight and obesity affecting the 34.9% of environment also plays an important role in the develop- children aged 8–16 years [2]. This prevalence is one of ment of obesity in children [14]. Family Based Interven- the highest rates in Europe [3]. Overweight and obesity tions (FBI) demonstrated positive results in preventing have several consequences, as almost every organ system childhood obesity, but SES contributes to the complexity can be severely damaged, leading to cardiovascular and of reaching positive results [14, 29]. More evidence is musculoskeletal diseases, metabolic complications, gastro- needed to better understand parents’ influence on school intestinal disorders, and pulmonary dysfunction [4]. In age children’s lifestyles from disadvantaged backgrounds, addition, in children and adolescents, these health condi- which evidence suggest a strong relationship from early tions are related to psychosocial disorders, such as depres- childhood [30]. Moreover, only a limited number of sion, anxiety, and low self-esteem [5, 6]. These disorders FBIs-targeted risk behaviors other than diet and PA [31, are caused by an interaction between individual and con- 32]. The successful FBI that pretend to produce a posi- textual factors [7]. There is a well-studied association be- tive effect on weight status and lifestyles should follow a tween obesity and some personal determinants, such as multicomponent and multilevel approach [33–35]. This dietary habits [8], physical activity (PA) [9], sleep [10, 11], means that educational family interventions should also and psychological well-being [12, 13]. Similarly, environ- tackle political and social factors. Moreover, they should mental variables, such as parental and socioeconomic involve the key sectors where families spend their daily characteristics, likely contribute to the problem [13–15]. time such as school, primary care centers, sport organi- Indeed, higher levels of childhood obesity have been con- zations, leisure time facilities, etc. in order to build full sistently found in children with a low socio-economic sta- community-based interventions. tus (SES), leading to health inequalities [16]. The FIVALIN study protocol will use a multiple be- Inequalities in childhood obesity seem to have in- havioral approach to simultaneously target diverse risk creased in developed countries during the last two de- behaviors, such as healthy eating, PA, screen time, sleep cades [16, 17]. These imbalances are related to economic quality and duration, and psychological wellbeing. In this development, cultural factors, and social and health pol- way, our study will give a more comprehensive view of icies [18, 19]. In high-income countries, low SES is asso- the value of FBIs in preventing childhood obesity among ciated with 16% higher risk of overweight, and 43% low SES families. higher risk of obesity in children aged 0–15 years [20]. In Spain, the percentage of 2- to 17-year-old children Methods with obesity is 11.45% higher in families where mothers Study design have a lower SES [21]. In particular, in Catalonia, 0- to To determine the effects of the FIVALIN project, we will 14-year-old children of mothers with a low level of edu- perform a quasi-experimental design with a control cation have a 5.33% higher level of obesity, in compari- group. son to children of highly educated mothers [22]. A recent study in Catalonia between 2006 and 2016 Aim showed that this health condition tends to increase or be The aim of this manuscript is to describe the study maintained in children from deprived areas, whereas protocol of the FIVALIN (Acronym of FItness, VAlues richer regions showed a downward trend [23]. In par- and Healthy LIfestyles) project. This is an FBI to prevent ticular, in Barcelona city, different factors play an im- pediatric obesity in 8- to 12-year-old children, through portant role on childhood obesity prevalence: social promoting healthy lifestyles, among low-income families class, geographical origin, family status, and the district in Barcelona. of residence [24]. The reasons why children from low SES are at higher Subjects risk of becoming overweight are likely to be multifaceted The study will involve low SES children aged 8–12 years and determined by different parameters: i) structural and their families from 60 Community Child Centers Homs et al. BMC Pediatrics (2021) 21:246 Page 3 of 14 (CCC) in the metropolitan area of Barcelona. A CCC is impossible to implement the assessment protocol a childcare center that promotes the education of chil- and project activities. dren from low income families by providing them aca- demic support and emotional education after school. A Sample size calculation total of 810 children and 600 parents will be included in We estimate that it will be necessary to include 270 the intervention groups, and likewise for the control children and their parents, both in the intervention and groups. These population samples will be distributed control groups, per edition of the FIVALIN project. We among three consecutive editions of the FIVALIN pro- expect a statistically significant decrease in body mass ject (2019–2020, 2020–2021, and 2021–2022), and will index (BMI) z-score of 0.15 in the intervention group, in include at least one adult and one child per low-income comparison to the control group. From the PRE to family. A total of 30 CCC (15 in the intervention group POST evaluations, for each of the three editions. Previ- and 15 as controls) will be involved per edition. CCC ous community intervention [35] that aimed to prevent from control group will be invited to be part of interven- childhood obesity through the promotion of healthy life- tion group on the subsequent edition, and15 new CCC styles, and were carried out in the same geographical will be recruited in the control groups of the second and context and among children of the same ages. They third editions. In total, after the three edition, 60 CCC showed a mean zBMI reduction of 0.10. The FIVALIN will be enrolled in the project (see Table 1). It is not ex- project is a more intense intervention and, for this rea- pected that CCC participating in the intervention group son, we expect a higher zBMI reduction. during first or second edition will continue providing We assume a 0.05 alpha risk, a 0.2 beta risk in a bilat- the intervention in subsequent editions. 18 socioeco- eral contrast, and 20% loss to follow-up. We expect to nomic vulnerable children (8- to 12-year-old) and their recruit significantly less families with 2 children in the families will participate per CCC. Therefore, considering age range of 8 to 12 years, than families with one child. the intervention and control groups, we expect a total Therefore, we performed a simplified approximation of participation of 540 children and 400 adults per edition. the sample size by counting only for one outcome (zBMI Participants will be recruited by CCC, by inviting fam- of one child). The sample size was calculated using the ilies that are already participating in their activities. They online sample size and power calculator GRANMO receive communicative material (flyers and leaflets) to (IMIM-Spain). introduce the project and motivate them to participate. For convenience, recruitment and allocation will be con- Intervention ducted by Gasol Foundation (GF), considering the char- The FIVALIN project is an FBI addressed to school age acteristics of the CCC: activities, number of educators, children (8- to 12-year-old) and their parents/caregivers. parents’ involvement, etc. It has been created to be part of a Multi-Level Multi Component (MLMC) intervention that pretends to prevent childhood obesity from early ages, and along all Inclusion and exclusion criteria for participants the developmental stages, until adulthood. The pre- Inclusion parameters adolescence stage is a key period to sustain the healthy lifestyles promotion activities to prevent a deterioration – Children aged 8–12 years and their families from a at subsequent stages. low SES. The FIVALIN project will be developed in three edi- – Enrollment in a CCC. tions (1st – 2019/2020; 2nd – 2020/2021; 3rd - 2021/ – Informed consent signed by parents/legal 2022) of 10 months each. The plan will be coordinated representatives. by the multidisciplinary health team of the GF, sup- ported by educators of the CCC and a trained team of Exclusion parameters volunteers. We expect that the GF team will be stable. To ensure intervention consistency, we will activate dif- – Children or parents/legal representative showing ferent strategies (see Additional file 1). Volunteers will psychological or physical disadvantages that make it be recruited by GF. They will contact the entity and, Table 1 Number of CCC per FIVALIN edition CCC from the 1st edition 2nd edition 3rd edition Intervention group 1 to 15 CCC (new) CCC from the control group of CCC from the control group of the 1° edition the 2° edition 16 to 30 CCC 31 to 45 CCC Control group 16 to 30 CCC (new) 31 to 45 CCC (new) 46 to 60 CCC (new) Homs et al. BMC Pediatrics (2021) 21:246 Page 4 of 14 after a welcoming training, they will be involved in the The following strategies will be applied to promote ad- project activities. herence and prevent attrition during the project planifica- The study will be conducted after school time in CCC tion and implementation: i) carry out a qualitative session in the metropolitan area of Barcelona. In CCC, parents in each participant CCC and community before starting the are encouraged to be part of their children’s education. intervention; ii) facilitate the logistics for attending the For the intervention group, we define two modalities of workshops by choosing CCC located in the families’ own participation (low and high), depending on the project communities and providing a childcare service for children intensity. The main difference between the two modal- under 5 years; iii) implement participative and respectful ac- ities is that children participating in the high intensity tivities during the family workshops, to highlight each posi- modality will do an extra activity, attending 32 sports tive lifestyle behavior, independently of the cultural educational sessions implemented by CCC educators. background, helping to generates a positive family attach- Each CCC will choose the modality that best fits their ment; iv) deploy a process evaluation protocol to identify internal organization (see Table 2 and Figs. 1, 2 and 3). areas for improvement, considering families, educators, and Additionally, educational material, mobile messages, and CCC opinions; v) consider various individual strategies videos will be sent to families in order to reinforce the based on the Motivational Interviewing principles directly health behaviors promoted during the workshops and addressed to parents (making individual follow up calls, sport educational sessions. Moreover, mobile messages using incentives, sending mobile messages to recall and will remind workshops date and hour to promote the thanks their participation in the project family workshops). participants attendance. CCC participating in the control In conclusion, the plan consists of a multicomponent group will be invited to be part of the intervention group intervention with strategies at different levels (children’s in the next edition. The control group will receive the education, families, and centers’ organization), that in- usual care provided in the CCC program plus a pre- clude several activities. evaluation and post-evaluation session. Moreover, they will receive a family workshop aimed to generate healthy Data collection lifestyle awareness and engagement, in order to reduce Anthropometric variables shortcomings in the post-evaluation. Weight will be recorded to the nearest 100 g using an The project uses theoretical models based on social cog- electronic scale (SECA 899), and height will be recorded nitive theory, such as: i) ASE (Attitude, Social influence, to the nearest 1 mm (without shoes) using a portable and Efficacy) model [36]; ii) Transtheoretical model [37]; SECA 213 stadiometer. Waist circumference will be and iii) Motivational interviewing (MI) [38]. Furthermore, assessed in the narrowest zone between the lowest rib the study will also use the Resiliency Theory [39] (see and iliac crest, in the vertical position, with a flexible Additional file 2). Finally, we will implement a multiple non-stretch tape measure (SECA 201). Every device is behavioral approach that considers dietary habits, PA and systematically calibrated and all measurements will be sport, screen time, sleep duration and quality, and psycho- performed by a GF-trained researcher. logical wellbeing, among children and their parents. Healthy lifestyles will be implemented by using a peda- gogical metaphor for the determinants of childhood Online questionnaires obesity, the Healthy Galaxy [40]. The metaphor is based All lifestyle data will be reported using online question- on a fantastic recent human story, where healthy habits naires. Parents will report information on screen time, decided to take off from planet Earth for a new Healthy diet, sleep duration and quality, and psychological well- Galaxy, where they created 4 planets: PA, healthy eating, being of their children. They will also take a question- sleep quality and duration, and emotional wellbeing (see naire on their own lifestyles and sociodemographic Figs. 4, 5 and 6). This story will motivate and promote characteristics. Children will complete a self-assessment families’ participation, while relating all the activities to questionnaire on PA and physical condition, with the one aim: families must return the healthy habits to the help of GF researchers and CCC educators. earth by travelling to the Healthy Galaxy. They will go around the galaxy on a spacecraft called FIVALIN and, The online questionnaires back on the planet Earth, they will have another mission: spread the word about everything they learned. A FIVALIN causal pathway was created based on I- A. Data collection for Children Change Model [41] (an integration of ASE model and Transtheoretical model) to clarify the logical framework 1. Diet Quality (KIDMED questionnaire) that relates the intervention, behavioral mechanisms, be- 2. Physical Activity (Physical Activity Unit- 7 Items - haviors, and weight status (see Fig. 7). PAU-7S) Homs et al. BMC Pediatrics (2021) 21:246 Page 5 of 14 Table 2 FIVALIN project activities description by participation options Activity description Intervention Control High intensity Low Intensity CCC Email and phone calls to invite CCC to participate in the project. Yes Yes Yes Communication material delivered: 1 poster per CCC and 1 project introduction Yes Yes No leaflet to each participant family. 1 qualitative session implemented with CCC educators (2 h) before the project Yes Yes No starts in the CCC to know participants’ family sociodemographic characteristics, their healthy lifestyles, and the CCC particularities. 3 training (4 h/training): face to face training with all the CCC participants educators Yes Yes No every 2 months in the GF headquarter to promote the FIVALIN community, and share project methodology, theoretical basis, and project follow-up indicators. Sport educational sessions guide delivered to CCC. The guide contains all the Yes No No sport educational sessions that should be implemented by the CCC educators. For each healthy habit, the guide includes: i) Health messages definition; and ii) Sport educational sessions description: 8 sport educational sessions for health topic. Sport material box delivered to CCC with all material needed to implement the Yes No No sport educational sessions. Follow-up online meetings (1 h/meeting) with CCC educators. Yes. 6 meetings Yes. 3 meetings No Children 32 sport educational sessions (1 h/session) implemented by CCC educators using Yes No No the sport educational sessions guide and sport material delivered. For each healthy habit, 4 health messages are promoted. For each healthy habit, 2 sport educational sessions are implemented. Family (children and adults) 8 family workshops Yes. 8 Workshops: Yes. 3 Workshops: (2 h/workshop) involving a group of 15 to 20 children and parents from each CCC (1) Baseline evaluation (1) Baseline evaluative implemented in the CCC by GF staff with the support of CCC educators. (2) Welcoming (2) General health (3) Sleep duration and quality awareness (4) Healthy Diet (3) Final evaluation (5) Emotional Wellbeing (6) PA & Sport (7) Closing (8) Final evaluation 32 mobile messaging sent to participants’ families by using text, images, and Yes Yes No infographics methods: (1) 8 mobiles messages, 1 before each family workshop, to recall families and promote their attendance. (2) 8 mobile messages, 1 after each family workshop, to reinforce the health topics promoted in the workshops. (3) 16 mobile messages, 1 after each cycle of 2 sport educational sessions dedicated to each healthy habit to reinforce it. 8 challenges videos done by high profile supporters (such as professional athletes Yes Yes No and celebrities) posing a healthy challenge as a family related to one health topic. Health promotion educational material shared with families after each workshop Yes Yes Yes to reinforce the health messages shared in the sessions and workshops. GF staff Weekly meeting (1 h) with project coordinators. Yes Yes Yes 3 training (4 h/training): face to face training with all GF staff that coordinate and Yes Yes Yes implement the project. Voice message report after each family workshop. Yes Yes Yes Ongoing support with project coordinators to tackle all the project needs. Yes Yes Yes Homs et al. BMC Pediatrics (2021) 21:246 Page 6 of 14 Fig. 1 FIVALIN High intensity intervention group modality Fig. 2 FIVALIN Low intensity intervention group modality Homs et al. BMC Pediatrics (2021) 21:246 Page 7 of 14 Fig. 3 FIVALIN control group modality 3. Physical Condition (The international Fitness Scale adherence to the Mediterranean diet in children and - IFIS) young adults. It is based on principles that are aligned or 4. Screen time-based and Sedentary Behavior (Screen not with the Mediterranean dietary pattern. The index time-based sedentary behaviour questionnaire - ranges from − 4 to 12 and is based on a 16-question test. SSBQ) Answers indicating a negative or positive behavior with 5. Sleep Hours (Sleep-Habits Survey for Adolescents respect to the Mediterranean diet are assigned a value of questionnaire - SHSA) − 1 or + 1, respectively. The sums of these values are 6. Sleep Quality (Bedtime Issues, Excessive Daytime classified into three levels: i) > 8, optimal Mediterranean Sleepiness, Night Awakenings, Regularity and diet; ii) 4–7, improvement needed to adjust intake to Duration of Sleep and Snoring questionnaire - Mediterranean patterns; iii) < 3, poor diet quality. BEARS) 7. Behavior (Strengths and Difficulties Questionnaire - Physical activity Level of PA will be evaluated by using SDQ) the Physical Activity Unified-7 item Screener (PAU-7S) (see Additional file 3), which is self-reported by the child Diet quality Diet quality will be evaluated using the (validity results sent for publication and currently under KIDMED index [42], which is based on 16 items with a review). The PAU-7S consists of 7 questions referring to dichotomous (yes/no) response format, reported by the week before the test. Questions 1–3 address different parents. The KIDMED test was created to estimate types of PA, such as walking, team sports, and individual Fig. 4 The Healthy Galaxy characters Homs et al. BMC Pediatrics (2021) 21:246 Page 8 of 14 Fig. 5 The Healthy Galaxy Communication material. Poster and Flyer example activity, respectively. Questions 4–6 address the context and flexibility. They will rank themselves as “very poor”,” where the PA was practiced: schoolyard, after school poor”, “average”, “good” or “very good”. The appraisal of and on weekends, and physical education classes, re- a good/very good overall physical condition, CRF, or spectively. The last question refers to whether the child SP–AG indicates a healthy cardiovascular profile. was ill during the previous week or was unable to per- form PA for some reason. Questions 1–6 will be an- Screen time and sedentary behavior Sedentary behav- swered according to 5 possible options that refer to time iors will be assessed using the Screen-Time-based spent (no activity = 0 min, < 30 min, 30–60 min, 60–90 Sedentary Behavior Questionnaire (SSBQ) [44], which is min, and > 90 min). The questionnaire will give the total reported by parents. 6 questions inquire about behaviors amount of minutes dedicated to PA during the week be- such as: i) watching TV; ii) playing computer games; iii) fore the test. playing console (video) games; iv) using internet for non-study reasons (hobbies); v) using for study reasons; Physical condition Children’s physical condition will be and vi) studying (outside the school schedule). Parents assessed using the International Fitness Scale (IFIS) self- will separately answer the 6 questions for weekdays and rating questionnaire [43]. IFIS is composed of five weekends, and will indicate the usual time devoted to Likert-scale questions on children’s shape, in compari- the 6 habits: 0 min; < 30 min; 30–60 min; 60–120 min; son to that of their friends. Children will evaluate their 120–180 min; 180–240 min; and > 240 min. The number own overall physical condition, cardiorespiratory fitness of sedentary minutes per day will be rated according to (CRF), muscular fitness (MF), speed–agility (SP–AG), the following categories: 1 = 0 min, 2 = 15 min, 3 = 45 Fig. 6 Educational material included in family activities Homs et al. BMC Pediatrics (2021) 21:246 Page 9 of 14 Fig. 7 FIVALIN causal pathway min, 4 = 90 min, 5 = 150 min, 6 = 210 min, and 7 = 241 attributes: 5 scales including 5 items each. The scales min, respectively. Weekly sedentary time is calculated by consist in: i) emotional symptoms; ii) conduct problems; taking the mean time in the selected category and apply- iii) hyperactivity/ inattention; iv) peer relationship issues; ing this formula: [(weekdays*5) + (weekend days*2)]/7. and v) prosocial behavior. Parents have three possible The total sedentary score is obtained by summing the choices for each item on these scales: Not True, Some- time reported in each category. Higher scores indicate what True, and Certainly True. For all scales, higher higher levels of screen time and sedentary behavior. scores indicate more problems, except for the last scale, where higher scores correspond to fewer difficulties in Sleep duration and quality Sleep patterns will be prosocial behavior. In addition, children will answer a assessed using the BEARS Questionnaire [45], which will brief self-report question on their own health. be completed by parents to evaluate potential sleep problems in children. We will consider 5 major sleep do- Other data collected We will collect data on birth mains, such as: B = Bedtime issues; E = Excessive daytime weight and breastfeeding using a standard questionnaire sleepiness; A = night Awakenings; R = Regularity and to be completed by the adults. duration of sleep; and S = Snoring. Parents will give a yes or no response for each domain. B. Data collection for Parents Parents will also complete a Sleep-Habits Survey for Adolescents (SHSA) [46], which will serve to estimate 1. Diet Quality (short Diet Quality Screener - sDQS) children’s sleep duration. 4 questions will inquire about 2. Physical Activity (REGICOR Short Physical Activity usual sleeping and waking behaviors. Parents will report Questionnaire) the time their children go to bed and wake up during 3. Sleep Duration school days and at weekends. 4. Perceived Stress (Perceived Stress Scale - PSS) Psychological wellbeing For behavioral screening, the Diet quality Diet quality will be analyzed by using a Strengths and Difficulties Questionnaire (SDQ) [47], a self-report questionnaire: the short Diet Quality Screener brief questionnaire for 3- to 16-year-old children, will be (sDQS) [48]. Parents will be asked to base their re- completed by parents. The SDQ collects data on 25 sponses on their dietary behaviors over the previous 12 Homs et al. BMC Pediatrics (2021) 21:246 Page 10 of 14 months, reporting their usual intake of 18 food items, actions implemented in the CCC. The latter will be col- grouped in 3 categories. These categories are based on lected at the beginning of the project. Moreover, we will recommended frequencies of food intake. Consumption also collect CCC staff data on the following parameters: frequency will be rated 1, 2, or 3 for healthy food items, (i) socio demographic characteristics; (ii) educational and 3, 2, 1 for the unhealthy food items. All scores will level and studies; and (iii) grade of motivation and be added up. Outcomes will range from 18 (low quality awareness through healthy lifestyle promotion, at the be- diet) to 54 (high quality diet). ginning and at the end of each edition. Physical activity PA will be assessed by using a self- Evaluation plan report REGICOR [49] questionnaire on exercise type, We will collect all data for each edition at baseline and frequency (days per month), and duration (minutes per 10 months after the intervention (post-evaluation). day). The questionnaire also provides categorical infor- Moreover, a follow up evaluation will be performed in mation about PA at work or in everyday life and gives a the intervention group 12 months after the post- weekly total amount of training minutes. evaluation, to study whether the impact of FIVALIN is sustained in the long term. After the assessment ses- Sleep duration Parents’ sleep duration will be calculated sions, each participating family from the intervention by asking about their usual sleeping and waking times and control groups will receive an incentive (e.g., a re- on weekdays and weekends. usable water bottle, a technical shirt, or a ball). The intervention fidelity and process evaluation indi- Perceived stress The Perceived Stress Scale (PSS) [47] cators will be assessed in different ways, such as: i) peri- will be used to measure the perception of stress. This odical project coordinators meetings; ii) follow-up self-report questionnaire includes several direct queries meetings and evaluation sessions with CCC educators; about current levels of stress experienced. Questions iii) voice audios after project activities recorded by GF refer to feelings and thoughts during the previous educators; iv) registration of family attendance and level month. The complete version of the test contains 14 of satisfaction after each workshop; and v) a qualitative questions with 5 response categories each (0 = never, 1 = assessment at the end of each project edition (focus almost never, 2 = occasionally, 3 = often, 4 = very often). groups and interviews to key stakeholders). The evidence PSS scores are obtained by reversing responses (e.g., 0 = derived from the previous assessment activities will be 4, 1 = 3, 2 = 2, 3 = 1, and 4 = 0) to 4 positively stated used with 2 aims, such as: (i) improve the project man- questions (4, 5, 7, and 8), and then summing the values. agement after each edition; and (ii) incorporate future Scores of 0–13, 14–26, and 27–40 indicate low, moder- improvements to the project basis, once the three edi- ate, and high perceived stress, respectively. tions will be implemented and the final data of the present study will be gathered. The project methodology, Other data collected Additional data will be collected activities, assessment tools, staff profile, and the ex- about the following items: pected outcome will be the same for the 3 editions be- cause a final evaluation of pooled data will be – Socioeconomic status (annual income, and performed. educational and occupational levels) – Smoking status Statistics – Family meals per week We will analyze the pooled data from the three timely – Family PA per week different editions with a 10-month intervention each. – Family postal address Data clean-up will be performed to minimize errors. To – Number of years parents and children have been compare groups, we will use the Student-t test for con- living in Spain tinuous variables and chi-square test for categorical vari- – Household characteristics ables. Allocation to the intervention group will be performed at the CCC level (clusters) by convenience. Therefore, generalized estimating equation (GEE) C. Data collection for educators and CCC models will be fitted to assess intervention effect on BMI z-score and other secondary outcomes at individual We will collect data on CCC characteristics, such as: level. To assess the outcome at family level, we will apply (i) location; (ii) total number and ages of children, and mixed models. family workshop and sport educational sessions attend- Due to the small number of clusters, GEE models esti- ance; (iii) number of people of the staff; and (iv) if ap- mation will be followed by t test with the Kauermann plicable, number and characteristics of health promotion and Carrol-corrected sandwich estimator. In alternative, Homs et al. BMC Pediatrics (2021) 21:246 Page 11 of 14 we will use the Wald t test with the FG-corrected sand- One limitation of the FIVALIN project could be the wich estimator, depending on the variation in cluster self-selection biases. Considering that participation is size (function “saws” from R package saws) [50]. FG- voluntary, parents with concerns about their children’s corrected sandwich estimation is not possible with weight or health behavior might be more interested in mixed models. For this reason, we will apply GEE the study. Moreover, CCC educators’ individual aware- models for the analyses. BMI z-score and other second- ness and motivation could influence the effects of the ary outcomes at baseline will be used as covariates to ad- intervention. The project also poses the challenge of just the models. Final models will be adjusted for how to engage parents. Parents’ involvement has to be baseline covariates such as: age, sex, mother’s educa- considered as a potential “agent of change” in the devel- tional level, adherence to the Mediterranean diet, PA, opment of their children’s health-related behaviors [14]. and the corresponding anthropometric variable (function A systematic review indicated that the level of parental “mgee” from R-packagesaws). A fidelity score will also involvement appeared to positively impact the effective- be included as a covariate in the models. Differences be- ness of interventions on children’s weight and energy tween the intervention and control group were consid- balance-related behaviours [53]. Another compilation re- ered significant if p < 0.05. All analyses will be carried port suggests that interventions promoting participant out using SPSS V21.0 and R. engagement may be more beneficial to disadvantaged groups than to higher literacy/SES status families [54]. Various parental characteristics are associated with low Discussion participation: low SES, single parenthood, difficult living The epidemic of overweight and obesity presents a circumstances, stress, family dysfunction, and belonging major worldwide challenge for chronic disease avoidance to a minority group ethnicity [55]. Therefore, it is im- and health throughout life. Preventing overweight in portant to take these risk factors into account in order children may have the greatest long-term effects [51]. to improve the efficacy of preventive actions [15]. We Pediatric obesity is more common in population groups will undertake several strategies to minimize the effects with a lower SES [20]; therefore, strategies and programs of the above-mentioned barriers as described in the need to prioritize the inclusion of vulnerable groups methods section. The reliance on self-report over object- [52]. The FIVALIN project is an FBI that uses a novel ively measured is a weakness commonly assumed by the approach to prevent overweight among children through intervention studies. Another limitation is not having a promoting healthy lifestyles. The plan targets low-SES complete fidelity assessment to analyze project adher- families and is implemented via CCC. ence and competence beyond family attendance and few A major strength of this project is that we will be able actions related to process assessment. Although the fi- to carry out a follow-up 12 months after the post- delity plan must be improved, we have prioritized the evaluation. Another strength is the multiple behavioral definition and implementation of a feasible assessment approach. A systematic review revealed gaps in the be- plan to not produce an overburden to families and CCC havioral domains targeted in childhood obesity preven- educators. Thus, in the FIVALIN project, we take the tion, with only 16% of the analyzed intervention directed opportunity to implement assessment methodologies as at four behavioral domains (PA, Nutrition, Media use, voice message, that could contribute to future interven- and Sleep) [31]. However, it is important to target and tion addressed to families experimenting vulnerability, to evaluate all the behavioral domains that influence weight establish a feasible strategy to monitor fidelity. status. Indeed, FBI studies measuring secondary out- Finally, the potential bias based on non-randomized comes have found significant changes in two or more CCC group intervention assignment would be also a behavioral aspects [29]. limitation because, the CCC and educators could have a Although the internal features of the CCC prevent us higher level of motivation to participate in the high in- from conducting a properly randomized trial, the socio- tensity modality. As highlighted, this could influence demographic characteristics of the intervention and con- project effectiveness. Data regarding CCC and staff char- trol groups of the first edition of FIVALIN are similar. It acteristics will be collected and are described in methods could be argued that, since lifestyle variables will be mea- section. sured by self-administered questionnaires, the partici- In conclusion, the FIVALIN project will contribute to pants` low level of education may influence their ability to prevent childhood obesity among socioeconomically vul- understand and answer them. Nevertheless, families with nerable families. It will do so by using a multiple behav- the lowest reading and comprehension skills will receive ioral approach to simultaneously target healthy eating, the support of trained researchers to complete the ques- PA, screen time, sleep quality and duration, and psycho- tionnaires, and biases are expected to be similar in the logical wellbeing. Moreover, the behaviors targeted are intervention and control group. considered to be at the same level of importance and Homs et al. BMC Pediatrics (2021) 21:246 Page 12 of 14 will be analyzed as both primary and secondary out- Availability of data and materials comes. This approach will provide evidence on the influ- The datasets used and/or analyzed during the current study will be available from the corresponding author on reasonable request. ence of each behavioral area on the evolution of the weight status [29]. Declarations Abbreviations Ethics approval and consent to participate FIVALIN: Fitness, Values, and healthy Lifestyles; SES: Socioeconomic Status; Written informed consent is requested from each participating family and FBI: Family Based Interventions; CCC: Community Child Centers; GF: Gasol signed by parent or children legal guardian. Children and their families can Foundation; PA: Physical Activity; BMI: Body Mass Index; ASE: Attitude, Social leave the study at any time, and their data will be automatically deleted. influence, and Efficacy; MI: Motivational Interviewing; PAU-7S: Physical The anthropometric data collected will be kept strictly private, and in a Activity Unified-7 item Screener; IFIS: International Fitness Scale; gender-dependent manner. The study protocol was approved by the ethics CRF: Cardiorespiratory Fitness; MF: Muscular Fitness; SP–AG: Speed–Agility; committee (CEIm) of Fundació Sant Joan de Déu, Barcelona, Spain (CI PIC- SSBQ: Screen-Time-based Sedentary Behavior Questionnaire; BEARS: Bedtime 169-19). Any modification of the study protocol will be amended in the trial issues; Excessive daytime sleepiness; night Awakenings; Regularity and registration system (ISRCTN12682870). duration of sleep; Snoring; SHSA: Sleep-Habits Survey for Adolescents; The main results of the FIVALIN project will be disseminated to public SDQ: Strengths and Difficulties Questionnaire; sDQS: short Diet Quality through a press release and a press conference that will reach the main Screener; PSS: Perceived Stress Scale; CEIm: Ethics committee mass media in Spain. At the same time, results will be shared through the social networks of the Gasol Foundation. A summary of the main results will be shared with all the participants families and CCC’s and will be uploaded Supplementary Information to the Gasol Foundation web page. The online version contains supplementary material available at https://doi. A main results full report will be created, distributed and uploaded to the org/10.1186/s12887-021-02697-x. Gasol Foundation web page. This report will recognize all the authors’ contributions and will specify all the participants CCC and supporting Additional file 1. Strategies to train new staff and assure consistency of institutions. the intervention. List of strategies to ensure intervention consistency and train new staff. Consent for publication Not applicable. Additional file 2. Theoretical models applied in the FIVALIN project by project activities. List of project activities where Theoretical models are applied. Competing interests The authors declare that they have no competing interests. FIVALIN project Additional file 3. Physical Activity Unified-7 item Screener (PAU-7S). is financially supported by Nike, a commercial organization dedicated to English version of Physical Activity Unified– 7 items Screener (PAU-7S) ad- sport. ministered to children. Additional file 4. INFORMATION SHEET AND INFORMED CONSENT FIVA Author details 1 LIN STUDY. Gasol Foundation, Sant Boi de Llobregat, Spain. 2Faculty of Psychology, PSIT IC Research Group, Education and Sport Sciences Blanquerna – Universitat Ramon Llull, Císter, 34 08032 Barcelona, Spain. 3Gasol Foundation, Los Acknowledgements Angeles, CA, USA. 4ISGlobal, Barcelona, Spain. 5CIBER Epidemiology and The authors thank Nike Made To Play, who supported the implementation of Public Health (CIBERESP), Carlos III Health Institute, Madrid, Spain. 6Universitat this intervention via a grant. Also, we thank the families, professionals, and Pompeu Fabra, Barcelona, Spain. 7Fundació Institut Universitari per a la entities that have been involved in Gasol Foundation interventions, that recerca a l’Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, allowed us to define the methodology for the FIVALIN project. Thanks to the Spain. 8Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Spain. Gasol Foundation staff and volunteers who are not involved in the scientific 9 Global Research on Wellbeing (GRoW) research group, Blanquerna School of production: their contribution is nonetheless essential for implementation of Health Sciences – Universitat Ramon Llull, Padilla, 326-332 08025 Barcelona, the FIVALIN project. Thanks to entities, staff, and families, that have been Spain. 10Cardiovascular Risk and Nutrition Research Group (CARIN), IMIM involved in “VIDA! Health & Wellness”, “L’Esport Suma”, and “SAFALÍN” (Hospital del Mar Medical Research Institute), Barcelona, Spain. 11GREpS, projects, that allowed us to design the FIVALIN project. Thanks to Isaac Health Education Research Group, Nursing and Physiotherapy Department, Subirana for his collaboration on statistics definition. We appreciate the University of Lleida, Lleida, Spain. English revision by ThePaperMill. 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