Children, Families With Infants, Obesity & Overweight, Vulnerable Families
Conditions
Keywords
Pediatric obesity, Prevention, Vulnerable populations, Randomized controlled trial, Primary health care, Early intervention, Parenting interventions
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 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
BEHAVIORALBambú 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
Helena Vall Roqué
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. Age- and feeding-stage-appropriate versions of the questionnaire will be administered: (a) the specific FPSQ-28 version for children aged ≥2 years; and (b) the FPSQ version for children aged \<2 years, either the FPSQ milk-feeding version (for caregivers predominantly feeding their child with milk) or the FPSQ (semi-)solids version (for caregivers predominantly feeding their child with solid food. Each subscale is scored separately (range 1-5). No overall total score is calculated. Higher scores indicate greater endorsement of the feeding practice represented by the subscale. |
| 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) | The Movement Behavior Questionnaire is a self-administered questionnaire that measures physical activity, screen time and sleep in infants, toddlers and preschoolers. The two age-specific versions of the questionnaire will be used: the MBQ-Baby (MBQ-B) for infants who have not yet reached the walking milestone, and the MBQ-Child (MBQ-C) for children who are able to walk. The closed-ended versions of the MBQ will be used. The questionnaire does not produce a total score. It assesses individual movement behaviours (e.g., tummy time, physical activity, screen time, restrained time, sleep duration). Interpretation depends on the behaviour measured and its alignment with age-specific movement guidelines. |
| 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) | The Brief Physical Activity Assessment Tool is a self-administered 2-item questionnaire to identify "inactive" patients in primary care settings. Responses to the two items are combined into a total score ranging from 0 to 8. Higher scores indicate a better outcome, reflecting higher levels of physical activity and adherence to recommended activity guidelines. |
| 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) | Parents' eating patterns will be measured with the self-administered Dutch Eating Behavior Questionnaire. The questionnaire comprises three subscales (Restrained Eating, Emotional Eating, and External Eating), each scored separately by averaging item responses (range 1-5). No overall total score is calculated. Higher scores indicate greater endorsement of the eating behaviour measured by each subscale; the interpretation of whether this represents a more or less desirable outcome depends on the subscale. |
| Changes from baseline to post-intervention and each follow-up in infant sleep | 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. The complete BISQ will not be administered because the original questionnaire is not appropriate for the full age range of the study population. Sleep parameters derived from selected BISQ items will be analyzed individually. No total sleep score will be calculated; therefore, there is no overall minimum or maximum score. The direction of interpretation depends on the specific sleep parameter assessed (e.g., longer sleep duration is generally considered favorable, whereas more frequent night awakenings or longer nocturnal wakefulness may indicate poorer sleep). |
| Percentage of parents engaging with and finishing the program | 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. |
| Parents' acceptability and satisfaction with the program (evaluated with a Final Participant Satisfaction Questionnaire) | 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. Higher scores indicate greater acceptability and satisfaction with the intervention. |
| Group leaders' fidelity with the program (evaluated with the Leader Checklist) | 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. |
| Parents' and group leaders' overall experiences with the program (evaluated with individual interviews and focus groups) | 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. |
Countries
Spain
Contacts
CONTACTHelena Vall Roqué, PhD
CONTACTNuria Hidalgo
PRINCIPAL_INVESTIGATORCarola Orrego, PhD
Avedis Donabedian Research Institute
Outcome results
None listed