Bambú multicomponent early parenting program to prevent childhood obesity in vulnerable families
Evaluation of a Tailored Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families (Bambú Project): Randomized Controlled Trial With a Hybrid Type 1 Effectiveness-implementation Design
This program tests whether the Bambú multicomponent early parenting intervention in primary care can help prevent excess weight in children aged 6 months to 3 years from vulnerable families where at least one parent has overweight or obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 526 (estimated) |
| Sex | All |
| Sponsor | Avedis Donabedian Research Institute Academic / other |
| Locations | 3 sites (Barcelona, Catalonia and 2 other locations) |
| Trial ID | NCT07529704 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Primary caregivers aged 18 or older of a healthy term child aged 6 months to 3 years, living in vulnerable socioeconomic circumstances and with at least one parent who has overweight or obesity are ideal candidates.
Not a fit: Families with children born at low birth weight (<2500 g), from multiple births, or who do not meet the defined vulnerability criteria or cannot attend participating Spanish primary-care sites are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could help children maintain a healthier weight and establish better feeding, activity, and sleep habits that reduce long-term obesity risk.
How similar studies have performed: Previous randomized early-life multicomponent parenting interventions have shown mixed but promising results for modest reductions in childhood overweight, so this approach builds on emerging evidence but is not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥2 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 this trial is running
Barcelona, Catalonia and 2 other locations
- 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)
Study contacts
- Principal investigator: Carola Orrego, PhD — Avedis Donabedian Research Institute
- Study coordinator: Helena Vall Roqué, PhD
- Email: hvall@fadq.org
- Phone: +34932076608
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.