Prevention of Weight Gain Among Normal Weight, Obesity Susceptible, Pre-school Children - a Randomized Controlled Interventions Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,202
- 试验地点
- 2
- 主要终点
- Anthropometric measurements
研究概览
简要总结
Obesity prevention should remain a priority, although there is some evidence of a possible leveling off in some age groups across European countries and in USA, Japan and Australia. Besides adult health problems such as type-2 diabetes and cardiovascular diseases, obesity in childhood is associated with psychological and social problems, low self-esteem, stigmatization and being teased and bullied by friends. Danish research suggests that the causes behind the increase in obesity occurrence are present already in early childhood, and that prevention of obesity therefore has to start early. Research has suggested that at least three sub-groups can be considered susceptible to develop obesity: Children with obesity among their 1st degree relatives; children with a high birth weight or children coming from socially disadvantaged families (low socioeconomic status). Earlier intervention programs has showed little effect in preventing excessive weight gain and knowledge on how to develop effective intervention programs that reduce overweight and obesity remains limited. It has been suggested that future prevention programs may be more successful if specifically targeting groups that are at high risk, as mention above, of excessive weight gain.
Based on these suggestions, the "Sund Start" project was initiated. The purpose of the study was to determine whether aiming prevention towards 2-6 years old Danish children who were yet normal weight, but were considered susceptible to develop overweight or obese could prevent later on risk of becoming overweight or obese. Furthermore, to investigate if it was possible to improve diet habits, increase physical activity, reduce stress and improve sleeping habits among children at high risk for later on overweight and obesity.
The "Sund Start" project will contribute with knowledge about whether targeting normal weight, predisposed children is effective in preventing overweight and obesity, and if reduced stress and improved sleep, should be considered important new obesity prevention tools. Moreover, the project will contribute with knowledge about how to change lifestyle and its effects on development of overweight and obesity in high risk Danish preschool children.
详细描述
In 2009, data on all births between 2004 and 2007 in 11 selected municipalities from the greater Copenhagen area was obtained from the Danish national birth register at the National Board of Health. This register contains information on all births, whether at hospital or home, on factors such as birth weight and length, height and pre-pregnant weight of the mother, parity, and Central Personal Registry number (CPR-number). Data on socioeconomic status was obtained from the administrative birth forms. This was done manually using the CPR-numbers obtained from the birth register.
After selection of the children eligible for participation, the children were allocated to three groups, (intervention group, control group, shadow group) using computer based randomization. All siblings were allocated to the same group. After the random allocation, children from the intervention group and the control group were sent a letter with an invitation to participate in the project. Children from the shadow group were also identified, and their general practitioners were contacted and asked for information on each child's height and weight.
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 (Participant)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born between 2004-2007
- •Born in 11 selected municipalities in the greater Copenhagen area
- •Classified as susceptible to overweight and obesity (At least one of the following risk factors present: A high birth weight (> 4000 grams), maternal pre-pregnancy obesity (BMI > 28 kg/m^2), or maternal low education (<= 10 years)
- •Normal weight at baseline examination
排除标准
- •Moved to another municipality after birth,
- •Had requested protection from participation in statistical or scientific surveys based on data delivered from the Danish Central Person Registry
- •No permanent address
- •Lived in a children's home
- •Had emigrated
- •Registered in the Danish Central Person Registry as being disappeared or had unknown life status
- •Not speaking Danish
- •Overweight (including obesity) at baseline examination
结局指标
主要结局
Anthropometric measurements
时间窗: 10 years
Changes between baseline and 10 years follow.up per intervention year in: Height in cm Weight in kg BMI in kg/m\^2 BMI z-score in SD
次要结局
- Dietary intake(1.3 years)
- Priority of serving fruit and vegetables(1.3 years)
- Physical activity(1.3 years)
- Sleep duration(1.3 years)
- Child stress level(1.3 year)
- Parental stress level(1.3 years)
- Sleep quality(1.3 year)
- Daily physical activity: Enjoys being active(1.3 years)
- Meal habits: Eating breakfast together(1.3 years)
- Sleep quality: Difficulties falling asleep(1.3 years)
- Sleep quality: Bedtime routines(1.3 years)
- Meal habits: Eating dinner together(1.3 years)
- Meal habits: Appetite(1.3 years)
- Sleep quality: Difficulties waking up(1.3 years)
- Sleep quality: Sleep onset latency(1.3 years)
- Sleep quality: Dreams(1.3 years)
- Meal habits: Mealtime situation(1.3 years)
- Meal habits: Pickiness(1.3 years)
- Sleep quality: Joining parents' bed(1.3 years)
- Sleep quality: Falling asleep(1.3 years)
- Daily physical activity: Activity compared to other children(1.3 years)
- Daily physical activity: Activity with parents(1.3 years)
- Daily physical activity: Means of transportation(1.3 years)
研究者
Berit Lilienthal Heitmann
Professor, Ph.D.
Bispebjerg Hospital