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NCT Number: NCT07529704

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

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 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 4 monthly sessions, lasting 2 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 and the Balearic Islands (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.

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Key information

Conditions

Obesity & Overweight Body Weight Children Families With Infants Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Vulnerable Families

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Avedis Donabedian Para la Mejora de la Calidad Asistencial, Barcelona, Catalonia, Spain

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bambú program

Behavioral

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.

Primary outcomes

  1. Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score

    Time frame: Measured to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    The BMI z-scored will be measured using the WHO Child Growth Standards. "At risk for overweight," "overweight," and "childhood obesity" for children under five are defined as BMI z-scores >1 and ≤2, >2 and ≤3, or >3 standard deviations above the median established by WHO growth standards, respectively.

Secondary outcomes

  1. Changes from baseline to post-intervention and each follow-up in child dietary intake

    Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    Child dietary intake will be measured using the multiple-pass 24-hour recall, which is a brief interview that will be conducted by healthcare professionals who participate in the project.

  2. Changes from baseline to post-intervention and each follow-up in the Feeding Practices and Structure Questionnaire (FPSQ)

    Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    The Feeding Practices and Structure Questionnaire is a self-administered questionnaire that measures parental feeding practices, specifically maternal responsiveness to children's hunger/satiety signals facilitated by routine and structure in feeding.

  3. Changes from baseline to post-intervention and each follow-up in the Movement Behavior Questionnaire (MBQ)

    Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    The Movement Behavior Questionnaire is a self-administered questionnaire that measures physical activity, screen time and sleep in infants, toddlers and preschoolers.

  4. Changes from baseline to post-intervention and each follow-up in Brief Physical Activity Assessment Tool (BPAAT)

    Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    The Brief Physical Activity Assessment Tool is a self-administered 2-item questionnaire to identify "inactive" patients in primary care settings.

  5. Changes from baseline to post-intervention and each follow-up in the Dutch Eating Behavior Questionnaire (DEBQ)

    Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    Parents' eating patterns will be measured with the Dutch Eating Behavior Questionnaire. This is a self-administered questionnaire designed to assess three distinct eating styles: emotional eating, external eating, and cognitive restraint.

  6. Changes from baseline to post-intervention and each follow-up in infant sleep

    Time frame: Administered to the intervention and control group at baseline (prior to program initiation) and after the intervention (at 6, 12 and 18 months after baseline)

    Selected items (applicable to the whole children's age range included in the study) from the Brief Infant Sleep Questionnaire (BISQ) will be used to measure child sleep.

  7. Percentage of parents engaging with and finishing the program

    Time frame: Through intervention completion (9 sessions, approximately 6 months)

    Parents' attendance will be recorded after each session using attendance sheets. These data will be used to calculate overall compliance and engagement across the full intervention period.

  8. Parents' acceptability and satisfaction with the program (evaluated with a Final Participant Satisfaction Questionnaire)

    Time frame: Administered to the intervention group at intervention completion (approximately 6 months after baseline)

    Parents' acceptability and satisfaction with the program will be assessed with a Final Participant Satisfaction Questionnaire. Data will be collected after the last session of the intervention.

  9. Group leaders' fidelity with the program (evaluated with the Leader Checklist)

    Time frame: Through intervention completion (9 sessions, approximately 6 months)

    Fidelity with the program will be assessed after each session using the Leader Checklist completed by group leaders. Fidelity will be summarized across all sessions to evaluate adherence to the intervention protocol.

  10. Parents' and group leaders' overall experiences with the program (evaluated with individual interviews and focus groups)

    Time frame: Through intervention completion (approximately 6 months)

    Semi-structured individual interviews and focus groups will be conducted with parents and group leaders during the intervention and after the final session to explore barriers and facilitators, as well as acceptability, adoption, appropriateness, feasibility, penetration, and sustainability of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Vall Roqué, PhD

CONTACT

[email protected]

+34932076608

Nuria Hidalgo

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Helena Vall Roqué

Other

Collaborators

  • Andalusian Health Service
  • General Directorate of Public Health, Balearic Island, Palma
  • Health Research Institute of the Balearic Islands (IdISBa), Palma
  • Hospital Costa del Sol
  • Hospital Universitari Son Espases (Palma de Mallorca. Spain)
  • Loyola University
  • Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma
  • Public health research group of the Balearic Islands (GISPIB)
  • Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB)

Registry information

Official study title

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

Acronym: Bambú

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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