Effectiveness of a behavioural intervention to prevent excessive weight gain during infancy (The Baby Milk Trial): study protocol for a randomised controlled trial.
Effectiveness of a behavioural intervention to prevent excessive weight gain during infancy (The Baby Milk Trial): study protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-015-0941-5
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发表时间：
2015-10-06
期刊：
影响因子：
2.5
通讯作者：
Ong KK
中科院分区：
文献类型：
--
作者：
Lakshman R;Whittle F;Hardeman W;Suhrcke M;Wilson E;Griffin S;Ong KK
婴儿期是快速生长和习惯形成的时期，因此可能是预防肥胖的关键时期。婴儿期体重增加过多与后来的肥胖有关，与母乳喂养的婴儿相比，配方奶粉喂养的婴儿更容易增加体重。主要试验结果是从出生到1岁体重标准差评分的变化。我们将招募650至700名在婴儿出生后14周内引入配方奶喂养的父母参加一项单盲（评估者）平行组个体随机对照试验。干预的重点是照顾者（通常是母亲），主要结果的重点是婴儿。干预组将接受行为干预，目的是减少配方奶的摄入量，促进反应性喂养和健康断奶，并防止婴儿期体重过度增加。干预是基于社会认知理论和行动计划（“实施意图”）。它由三个部分组成：（1）动机部分，以加强父母的动机，以遵循婴儿奶粉喂养指南，（2）行动计划部分，以帮助将动机转化为行动，和（3）应对计划部分，以帮助父母处理困难的情况。它将由经过培训的促进者（研究护士）在6个月内通过三次面对面接触、两次电话接触和书面材料提供。对照组将与协调员进行相同数量的接触，并讨论有关喂养的一般问题。在基线、标准操作程序后6个月和12个月，将由经过培训的研究人员在不知道分组的情况下测量人体测量结局。经验证的问卷将评估牛奶摄入量、气质、食欲、睡眠、产妇生活质量和产妇心理因素。将在8个月时完成4天食物日记。试验结果将有助于为婴儿喂养指南提供信息，并了解婴儿喂养、行为、食欲和生长之间的联系。ISRTCN20814693。登记日期2011年1月13日。
Infancy is a period of rapid growth and habit formation and hence could be a critical period for obesity prevention. Excess weight gain during infancy is associated with later obesity and formula-fed babies are more likely to gain excess weight compared to breastfed babies. The primary trial outcome is a change in the weight standard deviation score from birth to 1 year. We will recruit 650 to 700 parents who introduce formula-milk feeds within 14 weeks of their baby's birth to a single (assessor) blind, parallel group, individually randomised controlled trial. The focus of the intervention is the caregiver (usually the mother), and the focus of the primary outcome is the infant. The intervention group will receive the behavioural intervention, which aims to reduce formula-milk intake, promote responsive feeding and healthy weaning, and prevent excessive weight gain during infancy. The intervention is based on Social Cognitive Theory and action planning (‘implementation intentions’). It consists of three components: (1) a motivational component to strengthen parents’ motivation to follow the Baby Milk feeding guidelines, (2) an action planning component to help translate motivation into action, and (3) a coping planning component to help parents deal with difficult situations. It will be delivered by trained facilitators (research nurses) over 6 months through three face-to-face contacts, two telephone contacts and written materials. The control group will have the same number of contacts with facilitators, and general issues about feeding will be discussed. Anthropometric outcomes will be measured by trained research staff, blind to group allocation, at baseline, 6 months and 12 months following standard operating procedures. Validated questionnaires will assess milk intake, temperament, appetite, sleep, maternal quality of life and maternal psychological factors. A 4-day food diary will be completed at 8 months. The results of the trial will help to inform infant feeding guidelines and to understand the links between infant feeding, behaviour, appetite and growth. ISRTCN20814693. Registration date 13 January 2011.