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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12682870
Enrollment
1880
Registered
2020-07-09
Start date
2019-10-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood obesity, lifestyles, socioeconomic vulnerability, inequalities Other

Interventions

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

Sponsors

Gasol Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Intellectual or physical characteristics that incapacitate their enrollment in the evaluation procedures

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 7, 2026