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

Official 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

Overview

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.

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: feed

Primary outcome measures

• 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)]

Secondary outcome measures (10)

• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• Percentage of parents engaging with and finishing the program [Time frame: Through intervention completion (9 sessions, approximately 6 months)]
• 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)]
• Group leaders' fidelity with the program (evaluated with the Leader Checklist) [Time frame: Through intervention completion (9 sessions, approximately 6 months)]
• Parents' and group leaders' overall experiences with the program (evaluated with individual interviews and focus groups) [Time frame: Through intervention completion (approximately 6 months)]

Eligibility 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 ≥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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Spain · 4 centers

• Gerencia de Atención Primaria de Burgos — Burgos
• Fundación Avedis Donabedian Para la Mejora de la Calidad Asistencial — Barcelona
• Atenció Primària de Mallorca — Palma de Mallorca
• Servicio Andaluz de Salud — Seville

Publications

• 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
• Guerra Toro HI, Jaramillo AP, Caceres VM. Family-Based Interventions for Pediatric Obesity: A Comprehensive Systematic Review and Meta-Analysis of Their Effectiveness. Cureus. 2024 Aug 1;16(8):e65919. doi: 10.7759/cureus.65919. eCollection 2024 Aug. PMID 39221382
• 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
• 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

Identifiers

NCT: NCT07529704 · PI24/01033 · 24/291-P

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗