Bambú multicomponent early parenting program to prevent childhood obesity in vulnerable families

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized primary-care intervention compares the Bambú multicomponent parenting program to usual care in families identified as socioeconomically vulnerable and with at least one parent having overweight or obesity. The main outcome is children's BMI-for-age z-score measured at baseline and at 6, 12, and 18 months, with secondary outcomes including responsive feeding, dietary intake, parent and child physical activity, parental eating styles, and child sleep. The intervention is adapted to families' socioeconomic context and delivered through primary-care settings. Eligible participants are primary caregivers aged 18+ of a healthy term child aged 6 months to 3 years who meet predefined vulnerability criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Mothers and/or fathers aged 18 years or older.
* Primary caregivers of a healthy child aged 6 months to 3 years, born at term (≥37 weeks of gestation).
* At least one parent with overweight or obesity (as defined by BMI criteria).
* Families in a situation of vulnerability, defined as meeting ≥1 of the following criteria: (1) Low educational level of at least one parent (≤ lower secondary education or equivalent); (2) Precarious employment situation during the past year, (3) Perceived financial difficulties during the past year; (4) Insecure or unstable housing conditions; (5) Single-parent family or prolonged absence of one of the primary caregivers; (6) Recent immigration (≤10 years) without a stable support network or with language barriers.

Exclusion Criteria:

* Parents of a child aged 6 months to 3 years with low birth weight (\<2500 g)
* Parents of a child aged 6 months to 3 years from a multiple birth (e.g., twins, triplets)
* Parents/caregivers of a child aged 6 months to 3 years with congenital conditions, chronic diseases, or severe disabilities that may affect feeding, growth, or participation in the study
* Parents or caregivers with severe physical or mental health conditions that would limit their ability to participate in the intervention or assessments
* Families planning to move out of the study area during the study period

Where it's running

• Fundación Avedis Donabedian Para la Mejora de la Calidad Asistencial
  Barcelona, Catalonia, Spain Recruiting
• Atenció Primària de Mallorca
  Palma de Mallorca, Spain Recruiting
• Servicio Andaluz de Salud
  Seville, Spain Recruiting
• Gerencia de Atención Primaria de Burgos
  Burgos, Castille and León, Spain Not yet recruiting

Study contacts

• Principal investigator: Carola Orrego, PhD — Avedis Donabedian Research Institute
• Study coordinator: Helena Vall Roqué, PhD
• Email: hvall@fadq.org
• Phone: +34932076608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.