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
| Registry | NCT07529704, acronym Bambú |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 526 (Estimated) |
| Sponsor | Helena Vall Roqué (Other); collaborators: Loyola University, Andalusian Health Service, Hospital Costa del Sol, Hospital Universitari Son Espases (Palma de Mallorca. Spain), Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB), Health Research Institute of the Balearic Islands (IdISBa), Palma, General Directorate of Public Health, Balearic Island, Palma, Public health research group of the Balearic Islands (GISPIB), Universidad de Burgos, Instituto de Investigación Biosanitaria de Burgos (IBioBurgos), Gerencia de Atención Primaria de Burgos |
| Conditions | Obesity & Overweight, Vulnerable Families, Children, Families With Infants |
| Interventions | Bambú program (Behavioral) |
| Dates | start 2026-03-02, primary completion 2028-06-01 (estimated), completion 2028-09-01 (estimated), first posted 2026-04-14, last updated 2026-08-05 |
| Locations | 4 sites in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Obesity & Overweight All trials for Vulnerable Families All trials of Bambú program
Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity.
This study aims to evaluate the effectiveness of an early intervention in primary care for the prevention of childhood obesity, targeting vulnerable families where the mother and/or the father has overweight or obesity.
More specifically, the primary aim of this study is to evaluate the effectiveness the intervention to maintain a healthy weight in children aged 6 months to 3 years, measured by the BMI-for-age z-score at baseline, 6, 12, and 18 months, compared to usual care.
The study also aims to evaluate the effectiveness of the intervention, compared to usual care, for: promoting responsive feeding, improving dietary intake, improving parents' and children's physical activity levels, improving parents' eating styles, and improving children's sleep.
Finally, the study aims to determine the feasibility of implementing the intervention, and to identify factors influencing change and contextual factors in the implementation process.
A pragmatic cluster randomized controlled trial will be conducted. Approximately 526 families (parent-child family dyads) will be recruited, belonging to approximately 76 primary care centers. Primary care centers will be randomly assigned to either an intervention or control group.
The intervention has been previously co-designed with families and healthcare professionals, and consists of five weekly sessions and four monthly sessions, lasting two hours each. It will be delivered by previously trained healthcare professionals or by members of the research team, depending on the preferences and availability of the primary care center professionals. Approximately 38 intervention face-to-face groups will be conducted, one in each primary care center allocated to the intervention group.
The study will be conducted in Catalonia, Andalusia, the Balearic Islands and Castile and León (Spain).
Effectiveness outcomes include child body mass index (BMI) z-score, parent feeding practices (measured with the Feeding Practices and Structure Questionnaire), child dietary intake (measured with the multiple-pass 24-hour recall), parents' eating behaviours (measured with the Dutch Eating Behavior Questionnaire), child movement (measured with the Movement Behavior Questionnaire), parents' movement behaviours (measured with the Brief Physical Activity Assessment Tool), and child sleep (measured with selected items from the Brief Infant Sleep Questionnaire).
Implementation and feasibility outcomes will be assessed through interviews during and at the end of the intervention, and through attendance sheets and a final satisfaction questionnaire.
This study will provide pioneering insights into the implementation and effectiveness of this intervention within the public healthcare system in Spain. This will allow the potential implementation in the future at a larger scale.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group (Bambú program) | Experimental | Behavioral: Bambú program | This arm will include all primary care centers assigned to the intervention group. All participants (parents) within these centers will receive the Bambú intervention. They will participate in a 9-session group-based face-to-face intervention. Sessions will last 2 hours. The first 5 sessions will be delivered weekly and the following 4 sessions will be delivered monthly. They will be delivered at primary care centers in Catalonia, Andalusia, the Balearic Islands and Castile and León. They will be led by two professionals, either healthcare professionals working at the primary care center (who will be previously trained) or by members of the research team. The following main topics will be covered in the program: (1) nutrition; (2) physical activity and interactive play; (3) emotion regulation; (4) positive parenting; (5) child sleep; and (6) community support networks. Approximately 38 groups will be conducted, and each of them will include around 7 families. |
| Control group | No intervention | The control group will not receive the intervention. Families who are assigned to the control group will receive their usual care. No restrictions will be placed on families or primary care centers regarding access to other training and support services during the course of the study, but this information will be monitored as a potential confounder. Primary care centers who are assigned to the intervention group will be asked not to share the intervention contents with other centers who are in the control group before the end of the study. |
Sex: All, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Gerencia de Atención Primaria de Burgos | Burgos, Castille and León | Spain | Not yet recruiting |
| 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 |