Skip to content

A family-based psychosocial intervention to prevent pediatric obesity and build up healthy lifestyles from preschool ages through the promotion of parents' social skills, self efficacy, and resilience: The PRESAFALIN study

PRESAFALIN study protocol: A randomized controlled trial to evaluate the effects of a family-based psychosocial intervention to prevent pediatric obesity and build up healthy lifestyles from preschool ages through the promotion of parents' social skills, self efficacy and resilience

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15553317
Enrollment
1200
Registered
2024-01-08
Start date
2024-01-10
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Pediatric obesity Not Applicable

Interventions

The PRESAFALIN project will involve at baseline preschool children aged 0 to 5 years and their parents from 40 child day care centers (CDCC) and nursery schools (NS) situated across various regions of

Sponsors

IFA RETAIL, S.A.
Lead Sponsor
Diputació de Barcelona- Àrea d'Educació, Esports i Joventut
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children aged 0 to 5 years and parents living in Spain (Catalonia & Madrid). 2. Enrollment in a selected CDCC&NS. 3. Informed consent signed positively by parents/legal guardians.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
zBMI (kg/m²) and weight status measured using body weight (kg), height (cm) and waist circumference (cm) of each participant. Body weight and height measurements will be taken with participants wearing a t-shirt and lightweight trousers, while waist circumference will be measured by lifting the t-shirt at the mid-torso. The measurements will be conducted without shoes. For children aged 2 to 12 years and adults, an electronic scale (SECA 899) will be used with an accuracy to the nearest 100 grams. For children aged 0 to 2 years, the SECA 384 electronic scale will be employed. Height measurements will be carried out using a portable stadiometer (SECA 217) for children aged 2 to 12 years and adults, with an accuracy to the nearest 1 millimeter. For children aged 0 to 2 years, the SECA 417 stadiometer will be used. Additionally, a metric tape (SECA 201) with an accuracy to the nearest 1 millimeter will be utilized exclusively for children aged 6 to 12 years and adults. All measurements will be performed by trained field researchers.

Secondary

MeasureTime frame
Intervention (phase I): Self-Reported adult variables: 1. Self-efficacy assessed by the 20 items Perceived Maternal Parenting Self- Efficacy (PMP S-E) questionnaire. 2. Resiliency evaluated by Connor-Davidson Resilience 10 items reduced scale. 3. Competencies and Abilities assessed by 20 items ad-hoc questionnaire. 4. Self- perceived stress, measured by the 10 items Perceived Stress Scale (PSS). 5. Sleep duration assessed by 4 questions from Sleep Survey for Adolescents (SHSA) Questionnaire. 6. Diet Quality evaluated by the 18 items short Diet Quality Screener (SDQ) questionnaire. 7. Physical activity (PA) level and sedentariness assessed by the 7 questions REGICOR Short PA questionnaire. 8. For adult demographics: date of birth, gender, birth country, number of years living in Spain, education level, work situation, annual income, and smoking habits using questionnaires. 9. For children’s additional indicators: date of birth, gender, birth country, number of years living in Spain, home address, number of adults (under and older than18 y.o) living in the household, birth weight, weeks of pregnancy, birth typology (natural, vaginal, cesarean, others), and, breastfeeding months using questionnaires. Follow-up (phase II): Self-Reported adult variables: 1. Self-efficacy assessed by the 20 items Perceived Maternal Parenting Self- Efficacy (PMP S-E) questionnaire. 2. Resiliency evaluated by Connor-Davidson Resilience 10 items reduced scale. 3. Competencies and Abilities assessed by 20 items ad-hoc questionnaire. 4. Socioeconomic and environmental variables: education level, work situation, annual income, number of adults (under and older than18 y.o) living in the household and smoking habits. Self-Reported children variables at 8, 10 and 12 years old*: 1. Quality of Diet and Adherence to Mediterranean Diet evaluated by 16 items KIDMED index questionnaire. 2. Sleep duration recorded by 4 questions from the Sleep Habit Survey for Adolescents (SHSA). 3. Sleep quality eva

Countries

Spain

Contacts

Public ContactCristina Ribes Espinosa
admin@gasolfoundation.org+34 938 34 66 00

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026