School of Public Health, Sydney Medical School, University of Sydney, Sydney, NSW 2006, Australia.
BMJ. 2012 Jun 26;344:e3732. doi: 10.1136/bmj.e3732.
To assess the effectiveness of a home based early intervention on children's body mass index (BMI) at age 2.
Randomised controlled trial.
The Healthy Beginnings Trial was conducted in socially and economically disadvantaged areas of Sydney, Australia, during 2007-10.
667 first time mothers and their infants.
Eight home visits from specially trained community nurses delivering a staged home based intervention, one in the antenatal period, and seven at 1, 3, 5, 9, 12, 18 and 24 months after birth. Timing of the visits was designed to coincide with early childhood developmental milestones.
The primary outcome was children's BMI (the healthy BMI ranges for children aged 2 are 14.12-18.41 for boys and 13.90-18.02 for girls). Secondary outcomes included infant feeding practices and TV viewing time when children were aged 2, according to a modified research protocol. The data collectors and data entry staff were blinded to treatment allocation, but the participating mothers were not blinded.
497 mothers and their children (75%) completed the trial. An intention to treat analysis in all 667 participants recruited, and multiple imputation of BMI for the 170 lost to follow-up and the 14 missing, showed that mean BMI was significantly lower in the intervention group (16.53) than in the control group (16.82), with a difference of 0.29 (95% confidence interval -0.55 to -0.02; P=0.04).
The home based early intervention delivered by trained community nurses was effective in reducing mean BMI for children at age 2.
Australian Clinical Trial Registry No 12607000168459.
评估家庭为基础的早期干预对儿童 2 岁时体重指数(BMI)的有效性。
随机对照试验。
2007-2010 年期间,澳大利亚悉尼社会经济弱势群体地区进行的健康开端试验。
667 名初次生育的母亲及其婴儿。
由经过专门培训的社区护士进行八次家访,提供阶段性家庭为基础的干预措施,一次在产前期间,七次在婴儿出生后 1、3、5、9、12、18 和 24 个月进行。访问的时间安排旨在与幼儿发育里程碑相吻合。
主要结局是儿童的 BMI(2 岁儿童健康 BMI 范围为男孩 14.12-18.41,女孩 13.90-18.02)。次要结局包括 2 岁时婴儿喂养方式和电视观看时间,根据修改后的研究方案。数据收集员和数据录入人员对治疗分配情况不知情,但参与的母亲不知情。
497 名母亲及其子女(75%)完成了试验。对招募的 667 名参与者进行意向治疗分析,以及对 170 名失访者和 14 名缺失者的 BMI 进行多重插补,显示干预组的平均 BMI(16.53)明显低于对照组(16.82),差异为 0.29(95%置信区间-0.55 至-0.02;P=0.04)。
由经过培训的社区护士提供的家庭为基础的早期干预措施有效降低了儿童 2 岁时的平均 BMI。
澳大利亚临床试验注册中心号 12607000168459。