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首页> 外文期刊>BMC Public Health >Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study
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Three-year follow-up of a randomised controlled trial to reduce excessive weight gain in the first two years of life: protocol for the POI follow-up study

机译:随机对照审判的三年随访,以减少生命前两年的体重增加:POI后续研究的议定书

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Background The Prevention of Overweight in Infancy (POI) study was a four-arm randomised controlled trial (RCT) in 802 families which assessed whether additional education and support on sleep (Sleep group); food, physical activity and breastfeeding (FAB group); or both (Combination group), reduced excessive weight gain from birth to 2?years of age, compared to usual care (Control group). The study had high uptake at recruitment (58?%) and retention at 2?years (86?%). Although the FAB intervention produced no significant effect on BMI or weight status at 2?years, the odds of obesity were halved in those who received the sleep intervention, despite no apparent effect on sleep duration. We speculate that enhanced self-regulatory behaviours may exist in the Sleep group. Self-regulation was not measured in our initial intervention, but extensive measures have been included in this follow-up study. Thus, the overall aim of the POI follow-up is to determine the extent to which augmented parental support and education on infant sleep, feeding, diet, and physical activity in the first 2?years of life reduces BMI at 3.5 and 5?years of age, and to determine the role of self-regulation in any such relationship. Methods/design We will contact all 802 families and seek renewed consent to participate in the follow-up study. The families have received no POI intervention since the RCT finished at 2?years of age. Follow-up data collection will occur when the children are aged 3.5 and 5?years (i.e. up to 3?years post-intervention). Outcomes of interest include child anthropometry, body composition (DXA scan), diet (validated food frequency questionnaire), physical activity (accelerometry), sleep (questionnaire and accelerometry), and self-regulation (questionnaires and neuropsychological assessment). Discussion Our follow-up study has been designed primarily to enable us to determine whether the intriguing benefit of the sleep intervention suggested at 2?years of age remains as children approach school age. However, cohort analyses will also investigate how BMI, self-regulation, and sleep consolidation develop during the early years. This information will be valuable to researchers and policy makers progressing the field of early childhood obesity prevention. Trial registration ClinicalTrials.gov number NCT00892983 .
机译:背景技术预防婴儿期(POI)研究的超重是在802个家庭中进行了四臂随机对照试验(RCT),其评估了睡眠额外教育和支持(睡眠组);食品,身体活动和母乳喂养(Fab Group);或两者(组合组),与通常的护理(对照组)相比,从出生到2岁以下的重量增益减少到2年。该研究在招聘(58?%)的高度摄取和2年(86?%)。虽然Fab干预在2年内对BMI或体重状况产生显着影响,但尽管对睡眠持续时间没有明显影响,但肥胖的几率减半。我们推测睡眠组中可能存在增强的自我监管行为。在我们的初步干预中没有测量自我监管,但在这种后续研究中已包含广泛的措施。因此,POI随访的整体目标是确定在前2年的婴儿睡眠,喂养,饮食和身体活动中增强父母支持和教育的程度?生活中的3岁以上的BMI?年年龄,并确定自我监管在任何这种关系中的作用。方法/设计我们将联系所有802个家庭,并寻求再次同意参加后续研究。自RCT在2岁时完成以来,家庭没有收到POI干预。当孩子们年龄为3.5和5年龄时,将发生后续数据收集?年(即干预后3年3年)。感兴趣的结果包括儿童人类学,身体成分(DXA扫描),饮食(验证的食物频率调查表),身体活动(加速度),睡眠(问卷和加速度)和自我调节(问卷和神经心理学评估)。讨论我们的后续研究主要是为了使我们能够确定睡眠干预的有趣益处,建议在2年龄在儿童接近学龄。然而,群组分析还将调查BMI,自我监管和睡眠整合在早期的发展。这些信息对于研究人员和决策者来说,这些信息将为幼儿肥胖预防领域的领域。试验登记ClinicalTrials.gov数字NCT00892983。
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