Evaluation of a Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families

Summary

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.

Conditions

• Obesity & Overweight
• Vulnerable Families
• Children
• Families With Infants

Interventions

BEHAVIORAL

Bambú program

The Bambú program is a face-to-face 9-session group-based intervention for parents of children aged 6 months - 3.11 years, where at least one parent has overweight or obesity. Sessions last 2 hours. The first five sessions are delivered weekly and the other four sessions are delivered monthly. Sessions are led by two trained co-leaders (training includes two online sessions and access to a virtual platform with all intervention materials). The program covers six main topics: (1) nutrition: feeding practices and dietary recommendations; (2) physical activity and interactive play; (3) emotion regulation skills and techniques; (4) positive parenting; (5) child sleep; and (6) community support networks. The intervention is structured and includes video visualization and interactive activities. The program has been previously co-designed with families and healthcare professionals aiming to target it to the needs and preferences of vulnerable families with overweight or obesity.

Sponsors & Collaborators

• Loyola University

  collaborator OTHER

• Andalusian Health Service

  collaborator OTHER_GOV

• Hospital Costa del Sol

  collaborator OTHER

• Hospital Universitari Son Espases (Palma de Mallorca. Spain)

  collaborator UNKNOWN

• Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma

  collaborator UNKNOWN

• Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB)

  collaborator UNKNOWN

• Health Research Institute of the Balearic Islands (IdISBa), Palma

  collaborator UNKNOWN

• General Directorate of Public Health, Balearic Island, Palma

  collaborator UNKNOWN

• Public health research group of the Balearic Islands (GISPIB)

  collaborator UNKNOWN

• Universidad de Burgos

  collaborator OTHER

• Instituto de Investigación Biosanitaria de Burgos (IBioBurgos)

  collaborator UNKNOWN

• Gerencia de Atención Primaria de Burgos

  collaborator OTHER_GOV

• Helena Vall Roqué

  lead OTHER

Principal Investigators

• Carola Orrego, PhD · Avedis Donabedian Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-02

Primary Completion

2028-06-30

Completion

2028-09-30

Countries

• Spain

Study Locations