Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns (The COPE-study) - An Non-randomized Intervention Trial Investigating the Efficacy of Dietary Changes in Protein
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 211
- 试验地点
- 4
- 主要终点
- Body Mass Index Standard Deviation Score (BMI-SDS)
研究概览
简要总结
The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Secondary, the investigators want to investigate the effect of frequent follow-up after the intervention, and the overall effect of the lifestyle camp.
Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve quality of life, and risk factors for type 2 diabetes.
详细描述
The study will be performed in collaboration with the staff of the well-established multi-component-overnight camps (Julemærkehjem) in Denmark. The multi-component-overnight camps are intensive weight loss camps to which Danish schoolchildren, from 7-14 years of age, are referred to for 10-weeks intervention focusing on healthy lifestyle, healthy eating, new habits and increased physical activity.
The primary outcome is anthropometry (BMI-SDS, fat mass, fat-free mass). Secondary outcomes are metabolic health and questionnaires investigating quality of life, eating behavior traits, eating habits and eating-related problems i.e., overeating and loss of control eating.
The children will be measured at baseline, 10-weeks and at a 52-weeks follow-up visit.
Furthermore, participants will be invited to follow-up visits 3 years, 5 years, 7 years and 10 years, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
At enrollment the participants have no knowledge of which group they are assigned.
The investigator has no knowledge of or influence on how participants are divided into different groups. Participants are assigned groups by the camp staff.
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child attends a multi-component-overnight camp in Hobro or Fjordmark between October 2020 and March
- •The child is between 7 and 14 years of age (inclusive) while attending camp.
- •At least one parent/guardian submit written and oral consent to participate with his/her child.
- •Parent/legal guardian has submitted oral and written consent to participation of their child. In case of shared custody both parents must submit written and oral consent before their child can participate in the trial.
排除标准
- •The child has a disease, diagnose or eating disorder that require treatment.
- •The child or parent/guardian participate in another clinical trial or plan to do so in the near future.
- •The parent/guardian do not understand the written informed consent.
- •The child or parent/guardian are unwilling to or unable to comply with the study protocol and instruction given by the study staff.
结局指标
主要结局
Body Mass Index Standard Deviation Score (BMI-SDS)
时间窗: Mean changes from baseline to 10-weeks (post camp intervention)
BMI-SDS was calculated using World Health Organization Anthro-Plus software.
Body Weight (kg)
时间窗: Mean changes from baseline to 10-weeks (post camp intervention)
Body weight (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Body Fat (%)
时间窗: Mean changes from baseline to 10-weeks (post camp intervention)
Body fat (%) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
Skeletal Muscle Mass (kg)
时间窗: Mean changes from baseline to 10-weeks (post camp intervention)
Skeletal muscle mass (kg) was measured in light clothing without shoes using a Bioelectric impedance (InBody model 270, Hopkins Medical Products, Grand Rapids, MI, USA).
次要结局
- Body Height (m)(Mean changes from baseline to 10-weeks (post camp intervention))
- Systolic Blood Pressure(Mean changes from baseline to 10-weeks (post camp intervention))
- Diastolic Blood Pressure(Mean changes from baseline to 10-weeks (post camp intervention))
- P-cholesterol(Mean changes from baseline to 10-weeks (post camp intervention))
- ALAT(Mean changes from baseline to 10-weeks (post camp intervention))
- ASAT(Mean changes from baseline to 10-weeks (post camp intervention))
- HDL Cholesterol(Mean changes from baseline to 10-weeks (post camp intervention))
- LDL Cholesterol(Mean changes from baseline to 10-weeks (post camp intervention))
- P-glucose(Mean changes from baseline to 10-weeks (post camp intervention))
- P-tryglyceride(Mean changes from baseline to 10-weeks (post camp intervention))
- GGT(Mean changes from baseline to 10-weeks (post camp intervention))
- Basic Phosphatase(Mean changes from baseline to 10-weeks (post camp intervention))
- HbA1c(Mean changes from baseline to 10-weeks (post camp intervention))
- Albumin(Mean changes from baseline to 10-weeks (post camp intervention))
- CD163(Mean changes from baseline to 10-weeks (post camp intervention))
- Platelets(Mean changes from baseline to 10-weeks (post camp intervention))
- Uric Acid(Mean changes from baseline to 10-weeks (post camp intervention))