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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 526
- 试验地点
- 4
- 主要终点
- Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention group (Bambú program)
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, the Balearic Islands and Castile and León. 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.
干预措施: Bambú program (Behavioral)
Control group
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.
结局指标
主要结局
Changes from baseline to post-intervention and each follow-up in Body Mass Index (BMI) z-score
时间窗: 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.
次要结局
- 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))
- Percentage of parents engaging with and finishing the program(Through intervention completion (9 sessions, approximately 6 months))
- Group leaders' fidelity with the program (evaluated with the Leader Checklist)(Through intervention completion (9 sessions, approximately 6 months))
- Parents' and group leaders' overall experiences with the program (evaluated with individual interviews and focus groups)(Through intervention completion (approximately 6 months))
- 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))
- 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))
- 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))
研究者
Helena Vall Roqué
Principal Investigator
Avedis Donabedian Research Institute