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

NCT07529704 | Recruiting

• 2 other identifiers: PI24/0103324/291-P
• Study Type: interventional
• Target: 526
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

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

Keywords

Pediatric obesity; Prevention; Vulnerable populations; Randomized controlled trial; Primary health care; Early intervention; Parenting interventions

Outcome Measures

Primary Outcomes (1)

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

  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.

  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)

Secondary Outcomes (10)

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

  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)

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

  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)

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

  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)

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

  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)

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

  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)

Study Arms (2)

Intervention group (Bambú program)

EXPERIMENTAL

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 and Balearic Islands. 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.

Behavioral: Bambú program

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.

Interventions

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.

Intervention group (Bambú program)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (3)

Fundación Avedis Donabedian Para la Mejora de la Calidad Asistencial

Barcelona, Catalonia, 08037, Spain

RECRUITING

Atenció Primària de Mallorca

Palma de Mallorca, 07002, Spain

RECRUITING

Servicio Andaluz de Salud

Seville, 41008, Spain

RECRUITING

Related Publications (4)

• Epstein LH, Wilfley DE, Kilanowski C, Quattrin T, Cook SR, Eneli IU, Geller N, Lew D, Wallendorf M, Dore P, Paluch RA, Schechtman KB. Family-Based Behavioral Treatment for Childhood Obesity Implemented in Pediatric Primary Care: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1947-1956. doi: 10.1001/jama.2023.8061.

  PMID: 37314275 BACKGROUND

• Guerra Toro HI,Jaramillo AP,Caceres VM

  BACKGROUND

• Ciampa PJ, Kumar D, Barkin SL, Sanders LM, Yin HS, Perrin EM, Rothman RL. Interventions aimed at decreasing obesity in children younger than 2 years: a systematic review. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1098-104. doi: 10.1001/archpediatrics.2010.232.

  PMID: 21135337 BACKGROUND

• Blake-Lamb TL, Locks LM, Perkins ME, Woo Baidal JA, Cheng ER, Taveras EM. Interventions for Childhood Obesity in the First 1,000 Days A Systematic Review. Am J Prev Med. 2016 Jun;50(6):780-789. doi: 10.1016/j.amepre.2015.11.010. Epub 2016 Feb 22.

  PMID: 26916260 BACKGROUND

Related Links

• Website of the project

MeSH Terms

Conditions

Obesity; Overweight; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carola Orrego, PhD

  Avedis Donabedian Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helena Vall Roqué, PhD

CONTACT

+34932076608; hvall@fadq.org

Nuria Hidalgo

CONTACT

nhidalgo@fadq.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a cluster randomized controlled trial in which primary care centers (clusters) are randomized to intervention or control arms, and outcomes are measured at the individual participant level.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 14, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)