FIVALIN (fitness, values and healthy lifestyles) project: a family-based intervention to prevent childhood obesity among low socioeconomic status school aged children in Barcelona, Spain
| ISRCTN | ISRCTN12682870 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12682870 |
- Submission date
- 22/06/2020
- Registration date
- 09/07/2020
- Last edited
- 31/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The childhood obesity rates among the general population are alarmingly high and are even higher in socioeconomically deprived populations. In high-income countries, low socioeconomic position (SEP) is associated with a 16% higher risk of overweight and a 43% higher risk of obesity in children aged 0–15 years. A wide range of interventions has been implemented and tested to prevent obesity in children, but there is low evidence on the effects of interventions addressed to low socio-economic populations. For this reason, the aim of the FIVALIN study is to study the effects of obesity prevention and healthy lifestyle promotion intervention among vulnerable children (8-12 years old) and their families from community child centers.
Who can participate?
Family with children aged 8 to 12 years old who participate in community child centers
What does the study involve?
Sixty community child centres are allocated to an intervention group and a comparison group. The intervention group received 8-months healthy lifestyle promotion Intervention, while the control group received usual care provided in Community Child Centers (CCC) program plus two evaluation sessions (pre-evaluation and post-evaluation), and one family workshop at the middle of the project.
The intervention group actions involve children, adults and CCC educators. Children participate in 32 1-hour sport education sessions implemented by the CCC educators at each center. Adults and children participate in 8 2-hours family workshops implemented by Gasol Foundation staff. They also received 32 text messages plus 8 promotional videos in their smartphone and 4 packs of pedagogical material. CCC educators participate in 3 5-hours training during the project development, 6 follow-up online meetings and received an activity guide and a sport material box to promote healthy lifestyles and implement the sport educational sessions.
What are the possible benefits and risks of participating?
Regarding the benefits of participating in the study, the intervention group receive those incentives: pedagogical material, a T-shirt and a water bottle. The comparison group receive two incentives: a water bottle and a basketball. Participants family from the intervention group will also have benefits regarding the following points:
- Children are participating free of charge in sport educative sessions during the school year.
- Families are participating free of charge in family workshop that promote family cohesion, healthy role models and parenting practices.
A healthy lifestyles reinforcement or positive evolution and a positive weight status evolution is expected among the individuals that participate in the project activities.
No risks have been identified from the participation in this study.
Where is the study run from?
The Gazol Foundation (Spain)
When is the study starting and how long is it expected to run for?
September 2019 to September 2024
Who is funding the study?
NIKE Made To Play (USA)
Who is the main contact?
Dr Gómez Santos, sgomez@gasolfoundation.org
Contact information
Scientific
Gasol Foundation
Jaume I street, 26-28, First Floor
Sant Boi de Llobregat
08830
Spain
 ORCID ID |
0000-0003-3352-2510 |
|---|---|
| Phone | +34 8346600 |
| sgomez@gasolfoundation.org |
Scientific
Jaume I Street, 26-28, Office First Floor
Sant Boi de Llobregat
08830
Spain
| ORCID ID |
0009-0002-6355-6463 |
|---|---|
| Phone | +34 (0)938 34 66 00, +34 (0)669319411 |
| pberruezo@gasolfoundation.org |
Scientific
Gasol Foundation
Jaume I street, 26-28, First Floor
Sant Boi de Llobregat
08830
Spain
| ORCID ID |
0009-0002-6355-6463 |
|---|---|
| Phone | +34 (0)938346600 |
| pberruezo@gasolfoundation.org |
Study information
| Study design | Interventional non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The study protocol of the FIVALIN project: A family-based intervention to prevent childhood obesity among low socioeconomic status school aged children in Barcelona, Spain |
| Study acronym | FIVALIN |
| Study objectives | The participation as a family in the intervention group of the FIVALIN project predicts a better evolution of children's weight status and healthy lifestyles - diet, physical activity, sleep and emotional wellbeing - in comparison with children from a family allocated in the control group. |
| Ethics approval(s) | Approved 19/09/2019, CEIm Fundació Sant Joan de Déu (Medical Research Ethics Committee Sant Joan de Déu Foundation, Santa Rosa, 39-57 08950 Esplugues del Llobregat, Barcelona, Spain; +34 936 00 97 51; info@fsjd.org), ref: PIC-169-19 |
| Health condition(s) or problem(s) studied | Childhood obesity, lifestyles, socioeconomic vulnerability, inequalities |
| Intervention | The study has three editions of 10 months each. It is conducted in community child centers (CCC) that vulnerable children attend during leisure time, normally afternoons after school time. The CCC are located in the city and metropolitan area of Barcelona (Spain). Per edition a total of 30 CCC are recruited and per each center a group of 18-20 socioeconomic vulnerable children (8-12 years old) and their families participate. Per each edition, a total of 15 CCC are allocated to the intervention group and 15 others to the comparison group. The recruitment is conducted by Gasol Foundation for convenience being the main criteria to allocate the CCC, their possibility to accomplish during each edition with the intervention commitments. The CCC that participate as a comparison group in one edition is invited to participate as intervention group the next project edition. From the 30 CCC enrolled in each project edition a total of 540 children and 400 parents will be participating in the study, half of participants in the intervention group and in the comparison group. The present study aims to enroll, at the end of the three planned editions, 60 CCC, 1080 children and 800 parents. Some families will start their participation allocated in the comparison group and during the following edition will be allocated to the intervention group. The intervention group received 8-month Healthy Lifestyle Intervention, while the comparison group received usual care provided in CCC program plus two evaluation sessions (pre-evaluation and post-evaluation), and a family workshop at the middle of the project which aim is to motivate their involvement to reduce possible missing cases on the evaluation. The Healthy Lifestyle Intervention was designed based on an ecological perspective to prevent obesity among socioeconomically vulnerable children by promoting healthy lifestyles related on physical activity, healthy eating, sleep quality and duration and emotional wellbeing. The intervention comprised multi-level intervention strategies: child-level educational strategies, family strategies, and centre-level organizational strategies for obesity prevention and healthy lifestyles promotion among vulnerable children. Child strategies: - 32 sport educational sessions for physical activity, healthy eating, sleep quality and duration and emotional wellbeing for 8 months, 8 sport session per healthy lifestyle subject. CCC implement those sessions. Family strategies: - 8 family workshops involving children and adults: two-evaluation sessions, a welcoming workshop, one workshop per each item (physical activity, healthy eating, sleep quality and duration and emotional wellbeing) will be developed and a closure workshop involving all participants families from all CCC in one day healthy event. Gasol Foundation staff implement those workshops in each CCC. - 32 text messages. - 8 promotion videos sent by text messaging. - 4 packs of educative material. Center strategies: - 3 training workshops for two counselors of each CCC. - Delivery of an activity guide and a sport material box to promote healthy lifestyles and implement the sport educational sessions. - 6 follow-up online meetings. |
| Intervention type | Behavioural |
| Primary outcome measure | At baseline and 31 weeks: Body weight and height with the subjects wearing a t-shirt and light trousers and waist circumference elevating the t-shirt at the middle of their thorax. The measurements will be performed without shoes and using an electronic scale (SECA 899), to the nearest of 100 g, a portable SECA 217 stadiometer (to the nearest 1 mm), and a metric tape SECA 201 (to the nearest 1 mm). All measures are performed by trained field researchers. |
| Secondary outcome measures | At baseline and 31 weeks: 1. Children: Self report: 1.1. Physical activity (PA) assessed by the child's Physical Activity Unified - 7 items Screener (PAU-7S) 1.2. The use of accelerometers is still not confirmed but in case that will be used, participants will wear the ActiGraph wGT3X-BT accelerometer for 9 days 1.3. Fitness condition: will be measured by International Fitness Scale (IFIS) 1.4. Health status: will be measured by one question of the self-perceived health status from the questionnaire EQ-5D-Y-5L Report by parents: 1.5. Sedentary behavior: Will be measured by the Screen-time Sedentary Behavior Questionnaire (SSBQ) 1.6. Diet: Adherence to the Mediterranean diet will be recorded by the KIDMED index questionnaire 1.7. Sleep duration: The hours of sleep will be recorded by 4 questions from the Sleep Habits Survey for Adolescents (SHSA) 1.8. Sleep quality (of children) will be evaluated by the BEARS questionnaire 1.9. Emotional wellbeing: Will be measured by Strengths and Difficulties Questionnaire (SDQ) 1.10. Birthweight of children and if they received breastfeeding or not, measured by self-report 2. Parents: Self report: 2.1. Gender; weight and height; birthday; country of origin; number of people in the household; smoking habit; educational level; work situation; general health status; annual income 2.2. Sleep duration: The hours of sleep will be recorded by 4 questions from the Sleep Habits Survey for Adolescents (SHSA) 2.3. PA level and sedentariness evaluated by the REGICOR Short PA Questionnaire 2.4. Diet quality will be evaluated by the short Diet Quality Screener 2.5. Self-perceived stress will be measured by the Perceived Stress Scale (PSS) 2.6. Environmental variables: home address |
| Overall study start date | 10/09/2019 |
| Completion date | 01/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 1080 children and 800 adults |
| Total final enrolment | 2575 |
| Key inclusion criteria | 1. Participate in a CCC 2. Participant family with children aged 8 to 12 years old 3. Have the informed consent signed positively by the parents/legal representatives |
| Key exclusion criteria | Intellectual or physical characteristics that incapacitate their enrollment in the evaluation procedures |
| Date of first enrolment | 01/10/2019 |
| Date of final enrolment | 01/03/2023 |
Locations
Countries of recruitment
- Spain
Study participating centres
Sant Adrià del Besos
08930
Spain
Barcelona
08001
Spain
2a Planta
l'Hospitalet de Llobregat
08905
Spain
Montcada i Reixac
08110
Spain
Montcada i Reixac
08110
Spain
Barcelona
08038
Spain
baixos
l'Hospitalet de Llobregat
08906
Spain
Sant Adrià del Besòs
08930
Spain
l'Hospitalet de Llobregat
08903
Spain
Montcada i Reixac
08110
Spain
Barcelona
08027
Spain
Esc. A, Local
Barcelona
08042
Spain
Santa Coloma de Gramenet
08923
Spain
l'Hospitalet de Llobregat
08902
Spain
Barcelona
08033
Spain
Barcelona
08003
Spain
Sant Boi de Llobregat
08830
Spain
Barcelona
08020
Spain
Barcelona
08031
Spain
Barcelona
08001
Spain
Barcelona
08033
Spain
Sant Adrià del Besòs
08930
Spain
Sant Boi de Llobregat
08830
Spain
Barcelona
08033
Spain
Badalona
08917
Spain
Badalona
08913
Spain
Montcada i Reixac
08110
Spain
Barcelona
08010
Spain
Sponsor information
Charity
Jaume I street, 26-28
First Floor
Sant Boi de Llobregat
08830
Spain
| Phone | +34 938346600 |
|---|---|
| contact@gasolfoundation.org | |
| Website | http://www.gasolfoundation.org |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. All dataset will be available for research organizations since the first edition of the project with no limit data. Interested organization should requested by contacting with Gasol Foundation Head of Programs: - Name: Santiago Felipe Gómez Santos, PhD - E-mail contact: contact@gasolfoundation.org or sgomez@gasolfoundatin.org The research organitzation will be asked to inform of: - Name and legal status of the organization - Contact name and email - Main objective of using the dataset After review this information, if the main objective respect the ethical aspects and contribute on the mission of the Gasol Foundation, before sharing the dataset, the organization will sign a document that specify: - Ethical use of the data - The dataset analysis objective - Commitment to share with the Gasol Foundation the type of analysis |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/05/2021 | 24/05/2021 | Yes | No |
Editorial Notes
31/07/2024: Contact details updated.
29/07/2024: Total final enrolment added. The overall study end date was changed from 30/06/2023 to 01/09/2024.
21/06/2024: The intention to publish date was changed from 30/06/2024 to 01/09/2024.
04/03/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2021 to 01/03/2023.
2. The overall study end date was changed from 30/06/2022 to 30/06/2023.
3. The intention to publish date was changed from 30/06/2023 to 30/06/2024.
4. The plain English summary was updated to reflect these changes.
5. Contact details updated.
24/05/2021: Publication reference added.
10/07/2020: Internal review.
30/06/2020: Trial’s existence confirmed by CEIm Fundació Sant Joan de Déu
