Primary Prevention of Rapid Weight Gain in Early Childhood: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 802
- 试验地点
- 1
- 主要终点
- BMI z score
研究概览
简要总结
Obesity is one of the biggest threats to health in the 21st century. Rapid weight gain in the first year of life tends to lead to overweight in children, which in turn leads to overweight in adults. This rapid early weight gain occurs most often at weaning when eating patterns emerge. Infant sleep problems also appear to be associated with the risk of becoming overweight, and contribute to maternal post-natal depression. We propose to undertake a 4-arm randomised controlled trial to determine whether extra education and support for families around weaning and development of early food and activity habits, with or without intervention to improve infant sleep, will decrease the current risk patterns of rapid excessive early childhood weight gain in New Zealand. This would provide strong evidence for the value of such a strategy in the long term control of the obesity epidemic and its consequent complications.
This is a two-year intervention with follow-ups at 3.5, 5 and 11 years of age.
详细描述
We plan on undertaking a 4-arm randomised controlled trial to test the following hypotheses:
- That anticipatory guidance and extra education and support in infancy around weaning and decreasing/avoiding television watching will delay the timing of introduction of solid foods, will be associated with more successful introduction of nutrient dense foods with appropriate portion size and decrease small screen exposure leading to a lower number of children with excessive weight velocity in infancy and early childhood.
- That anticipatory guidance, education and extra support around the early development of infant sleeping patterns will decrease sleep problems, increase infant sleeping time, decrease arousals at night and lower sleep latency which will in turn influence rate of early infant weight gain.
- That interventions 1 and 2 will interact additively with regard to infant and early childhood weight gain.
- That intervention 2 will lead to lower rates of maternal depression and increased family well being.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers booked for delivery in Dunedin, New Zealand
排除标准
- •Women booked after 34 weeks gestation,
- •Identified congenital abnormality likely to affect feeding and/or growth
- •Home address outside of metropolitan Dunedin or Invercargill,
- •Families who are likely to shift out of metropolitan Dunedin or Invercargill in the next 2 years.
- •Unable to communicate in English or te reo Maori.
研究组 & 干预措施
Standard well child care
Standard Well Child Care (SWCC) - 8 Core visits at 2-4 weeks, 6 weeks, 3, 5, 8-10 and 15 months, 2 and 3 years.
Food Activity Breast feeding support
FAB (Food Activity Breast feeding support) 8 extra parent contacts for augmented education and support around breast feeding, food and activity
干预措施: FAB (Behavioral)
Sleep
Prevention of sleep problems in first 6 months and then active early intervention for sleep problems from 6 months to 24 months
干预措施: Sleep (Behavioral)
FAB + Sleep
combination of interventions used in arms 2 and 3
干预措施: FAB (Behavioral)
FAB + Sleep
combination of interventions used in arms 2 and 3
干预措施: Sleep (Behavioral)
结局指标
主要结局
BMI z score
时间窗: Follow-up at 11 years of age
BMI z score derived from height and weight and using WHO reference data
BMI z score
时间窗: 24 months (end of intervention)
BMI z score derived from ht and weight and using World Health Organisation (WHO) growth standards
BMI z score
时间窗: 60 months of age (followup at 5 years of age)
BMI z score derived from ht and weight and using WHO growth standards
次要结局
- Physical activity (PA)(24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up))
- Dietary intake(24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up))
- Parental depression score(Measured at multiple timepoints between pregnancy and 24 months (end of intervention) and 60 months (end of follow-up))
- Television viewing(24 months (end of intervention) and 60 months (end of follow-up))
- Sleep(24 months (end of intervention) and 60 months (end of follow-up) and 11 years (further follow-up))
- Major/ Moderate sleep problems(24 months (end of intervention))
- Duration of exclusive and any breast feeding(24 months)
- Number of night awakenings(24 months (end of intervention) and 60 months (end of follow-up))
- Self-regulation(42 and 60 months)
- Body composition(60 months and 11 years (further follow-up))
研究者
Barry Taylor
Professor
University of Otago