对弱势家庭儿童肥胖预防多组分早期干预的评估 (Bambú)
针对弱势家庭儿童肥胖预防的定制化多组分早期干预措施评估(Bambú项目):采用混合型1类有效性-实施设计的随机对照试验
儿童肥胖是一个公共卫生问题。 需要基于证据、多组分、针对幼儿期并根据家庭社会经济背景调整的育儿干预措施来预防儿童肥胖。
本研究旨在评估一项初级保健早期干预措施在预防儿童肥胖方面的有效性,针对母亲和/或父亲超重或肥胖的弱势家庭。
更具体地说,本研究的主要目的是评估该干预措施在维持6个月至3岁儿童健康体重方面的有效性,通过基线、6个月、12个月和18个月时的年龄别BMI z分数来衡量,并与常规护理进行比较。
本研究还旨在评估该干预措施与常规护理相比在以下方面的有效性:促进反应性喂养、改善饮食摄入、提高父母和儿童的体力活动水平、改善父母的饮食风格以及改善儿童的睡眠。
最后,本研究旨在确定实施该干预措施的可行性,并识别实施过程中影响变化的因素和情境因素。
将进行一项务实的整群随机对照试验。 将招募约526个家庭(亲子家庭对),来自76个初级保健中心。 初级保健中心将被随机分配到干预组或对照组。
该干预措施先前已与家庭和医疗保健专业人员共同设计,包括五次每周课程和四次每月课程,每次持续2小时。 它将由先前培训过的医疗保健专业人员或研究团队成员提供,具体取决于初级保健中心专业人员的偏好和可用性。 将进行约38个干预面对面小组,每个分配到干预组的初级保健中心一个。
该研究将在加泰罗尼亚、安达卢西亚和巴利阿里群岛(西班牙)进行。
有效性结果包括儿童体重指数(BMI)z分数、父母喂养实践(使用喂养实践和结构问卷测量)、儿童饮食摄入(使用多次24小时回忆法测量)、父母饮食行为(使用荷兰饮食行为问卷测量)、儿童运动(使用运动行为问卷测量)、父母运动行为(使用简短体力活动评估工具测量)以及儿童睡眠(使用婴儿睡眠简短问卷中的选定项目测量)。
实施和可行性结果将通过干预期间和结束时的访谈、出勤表和最终满意度问卷进行评估。
本研究将提供关于该干预措施在西班牙公共医疗保健系统中实施和有效性的开创性见解。 这将允许未来在更大规模上的潜在实施。
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Helena Vall Roqué, PhD
- 电话号码:+34932076608
- 邮箱:hvall@fadq.org
研究联系人备份
- 姓名:Nuria Hidalgo
- 邮箱:nhidalgo@fadq.org
学习地点
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Palma de Mallorca、西班牙、07002
- 招聘中
- Atenció Primària de Mallorca
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接触:
- Joana Ripoll Amengual
- 电话号码:+34626748937
- 邮箱:joana.ripoll@ibsalut.es
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Seville、西班牙、41008
- 招聘中
- Servicio Andaluz de Salud
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接触:
- Rosario Vigo Ortega
- 电话号码:+34955016700
- 邮箱:rosario.vigo.sspa@juntadeandalucia.es
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Castille and León
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Burgos、Castille and León、西班牙、09006
- 尚未招聘
- Gerencia de Atención Primaria de Burgos
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接触:
- Noelia Gallego-Ausín
- 电话号码:33794 34947240013
- 邮箱:ngallego@saludcastillayleon.es
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Catalonia
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Barcelona、Catalonia、西班牙、08037
- 招聘中
- Fundación Avedis Donabedian Para la Mejora de la Calidad Asistencial
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接触:
- Helena Vall Roqué, PhD
- 电话号码:+34 932076608
- 邮箱:hvall@fadq.org
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接触:
- Carola Orrego, PhD
- 电话号码:+34 932076608
- 邮箱:corrego@fadq.org
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 年龄在18岁或以上的母亲和/或父亲。
- 足月出生(妊娠≥37周)、年龄在6个月至3岁健康儿童的主要照顾者。
- 至少有一名家长超重或肥胖(根据BMI标准定义)。
- 处于脆弱状况的家庭,定义为满足以下≥2项标准:(1) 至少一名家长教育水平较低(≤初中或同等学历);(2) 过去一年就业状况不稳定;(3) 过去一年感知到经济困难;(4) 住房条件不安全或不稳定;(5) 单亲家庭或主要照顾者之一长期缺席;(6) 近期移民(≤10年)且无稳定支持网络或存在语言障碍。
排除标准:
- 6个月至3岁低出生体重(<2500克)儿童的父母
- 6个月至3岁多胎出生(如双胞胎、三胞胎)儿童的父母
- 6个月至3岁患有先天性疾病、慢性病或严重残疾,可能影响喂养、生长或参与研究的儿童的父母/照顾者
- 患有严重身体或心理健康问题,可能限制其参与干预或评估能力的父母或照顾者
- 研究期间计划搬离研究区域的家庭
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:对照组
对照组将不会接受干预。 被分配到对照组的家庭将接受他们通常的护理。 在研究过程中,不会对家庭或初级保健中心获取其他培训和支持服务施加任何限制,但此信息将作为潜在的混杂因素进行监测。 被分配到干预组的初级保健中心将被要求在研究结束前不要与对照组的其他中心分享干预内容。 |
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实验性的: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. |
Bambú项目是一项面向6个月至3.11岁儿童家长的面授团体干预计划,共设9次课程,要求至少一方家长存在超重或肥胖情况。每次课程时长为2小时。前五节课每周进行,后续四节课每月开展。课程由两名经过培训的协同带领者主持(培训包含两次线上课程及可访问包含所有干预材料的虚拟平台)。 该计划涵盖六大主题:(1) 营养:喂养实践与膳食建议;(2) 体育活动与互动游戏;(3) 情绪调节技巧与方法;(4) 积极育儿;(5) 儿童睡眠;(6) 社区支持网络。 干预方案为结构化设计,包含视频演示与互动活动。 该项目此前已与家庭及医疗专业人员共同设计,旨在满足超重或肥胖弱势家庭的需求与偏好。 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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从基线到干预后及每次随访期间身体质量指数(BMI)z值的变化
大体时间:在基线(项目启动前)和干预后(基线后6、12和18个月)对干预组和对照组进行测量
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BMI z 分数将使用 WHO 儿童生长标准进行测量。
对于五岁以下儿童,“有超重风险”、“超重”和“儿童肥胖”分别定义为 BMI z 分数 >1 且 ≤2、>2 且 ≤3,或 >3 个标准差,基于 WHO 生长标准确定的中位数。
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在基线(项目启动前)和干预后(基线后6、12和18个月)对干预组和对照组进行测量
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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从基线到干预后及各随访期的儿童膳食摄入变化
大体时间:在基线时(计划启动前)和干预后(基线后6、12和18个月)对干预组和对照组进行给药
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儿童膳食摄入量将采用多次回顾24小时膳食回忆法进行测量,该方法是由参与本项目的医疗保健专业人员进行的简短访谈。
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在基线时(计划启动前)和干预后(基线后6、12和18个月)对干预组和对照组进行给药
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参与并完成该计划的家长比例
大体时间:通过干预完成(9次课程,约6个月)
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每次课程结束后,将使用签到表记录家长的出席情况。
这些数据将用于计算整个干预期间的整体依从性和参与度。
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通过干预完成(9次课程,约6个月)
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项目负责人对计划的忠实执行情况(通过负责人检查表评估)
大体时间:至干预完成(9次干预,约6个月)
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每次课程结束后,将使用小组负责人填写的《负责人核对表》评估对项目的忠实度。
所有课程的忠实度将被汇总,以评估对干预方案的遵守情况。
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至干预完成(9次干预,约6个月)
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家长和小组负责人对该计划的整体体验(通过个人访谈和焦点小组进行评估)
大体时间:通过干预完成(约6个月)
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将在干预期间和最终课程结束后,与家长和小组负责人进行半结构化个人访谈和焦点小组讨论,以探讨干预措施的障碍和促进因素,以及干预措施的可接受性、采纳度、适当性、可行性、渗透性和可持续性。
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通过干预完成(约6个月)
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Changes from baseline to post-intervention and each follow-up in the Feeding Practices and Structure Questionnaire (FPSQ)
大体时间: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)
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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. |
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)
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Changes from baseline to post-intervention and each follow-up in the Movement Behavior Questionnaire (MBQ)
大体时间: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)
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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. |
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)
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Changes from baseline to post-intervention and each follow-up in Brief Physical Activity Assessment Tool (BPAAT)
大体时间: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)
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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.
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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)
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Changes from baseline to post-intervention and each follow-up in the Dutch Eating Behavior Questionnaire (DEBQ)
大体时间: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)
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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. |
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)
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Changes from baseline to post-intervention and each follow-up in infant sleep
大体时间: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)
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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). |
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)
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Parents' acceptability and satisfaction with the program (evaluated with a Final Participant Satisfaction Questionnaire)
大体时间:Administered to the intervention group at intervention completion (approximately 6 months after baseline)
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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. |
Administered to the intervention group at intervention completion (approximately 6 months after baseline)
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合作者和调查者
合作者
调查人员
- 首席研究员:Carola Orrego, PhD、Avedis Donabedian Research Institute
出版物和有用的链接
一般刊物
- 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.
- 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.
- 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.
- 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.
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PI24/01033
- 24/291-P (其他标识符:Ethics Committee for Research with Medicines (CEIm) of IDIAP Jordi Gol)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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