A Randomized Controlled Trial for Overweight and Obesity in Preschoolers - The More and Less Study Europe
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Change in body mass index (BMI) z-score.
研究概览
简要总结
Obesity interventions in early childhood are recommended as they have been proven to be more effective than interventions later in life. The overall aim of this study is to assess the effectiveness, feasibility, and acceptance of an overweight and obesity intervention in socially disadvantaged families. Participants will be families with children aged 2-6 years (n = 300) with overweight or obesity and will be recruited from three sites: Stockholm, Sweden (n = 100); Timisoara, Romania (n = 100); and Mallorca, Spain (n = 100).
详细描述
The proposed randomized controlled trial has five specific aims:
Specific Aim 1: To determine the effectiveness of a 10 week parent-only group support program focusing on evidence-based parenting practices followed by a mobile health (mHealth) component for 6-months (n = 150) compared to standard care (n = 150) for overweight and obesity in pre-school children (change in BMI z-scores after 9 months primary outcome).
Specific Aim 2: To determine if the intervention can improve body composition (waist circumference), child eating behaviour, physical activity, and parental feeding practices in comparison to the control group.
Specific Aim 3: To assess reversibility of the molecular signatures of obesity following the intervention through epigenetic markers in white blood cells (methylation) and analyzing the role of the gut hormones.
Specific Aim 4: To assess and validate child food intake with metabolic markers in urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •2 to 6 year old children with overweight or obesity according to international cut-offs.
- •Children who have no other underlying medical condition(s).
- •Parent(s) who have the ability to communicate in Swedish (for the Swedish part), Romanian (for the Romanian part), and Spanish (for the Spanish part).
排除标准
- •Parent(s) not owning a smartphone compatible with the MINISTOP app.
结局指标
主要结局
Change in body mass index (BMI) z-score.
时间窗: Baseline, 10 weeks, 9 months, 15 months, 21 months
It is the most commonly used indicator of changes in weight status in pediatric obesity studies and enable comparison between other studies. The children's weight and height will be measured using standardized procedures and BMI z-scores will be derived from Swedish age and gender specific reference values.
次要结局
- Physical activity and sedentary behaviour(Baseline, 9 months)
- Food intake(Baseline, 9 months)
- Waist circumference(Baseline, 10 weeks, 9 months, 15 months, 21 months)
- Feasibility, attrition, and acceptability of the intervention as assessed using semi-structured interviews with parents and health care professionals(Baseline, 4 months)
- Epigenetic and metabolic markers(Baseline, 9 months)
- Eating behaviour(Baseline, 9 months, 15 months, 21 months)
- Parenting behaviour(Baseline, 9 months, 15 months, 21 months)
研究者
Paulina Nowicka
Senior Researcher
Karolinska Institutet