METHODS: We aim to recruit 80 children and they randomize either to an intervention group or a control group with standard care. The intervention group receives intensive, family-based diet, and physical activity counseling, delivered by a multidisciplinary team of a pediatrician, a nurse, and a clinical nutritionist. The control group does not receive any lifestyle intervention during the study. The inclusion criteria are age of 6-12 years, weight-for-height ≥ + 40% or ≥ + 30%, and increasing curve. All participants fill out the study questionnaires and plasma samples are taken at baseline and at 12 months. Outcome variables will be compared between intervention and control groups.
CONCLUSIONS: If the effects of this lifestyle intervention are positive and it is also cost-effective, the implication of our study will be of great importance to the treatment of childhood obesity and to improve the health care system.
BACKGROUND: ClinicalTrials.gov NCT06126679. Registered on 25 October 2028 in Finland.
UNASSIGNED: 0009-0009-6659-5290.
方法:我们的目标是招募80名儿童,他们随机分为干预组或对照组,接受标准护理。干预组接受密集治疗,以家庭为基础的饮食,和身体活动咨询,由儿科医生的多学科团队提供,一个护士,和临床营养师.对照组在研究期间不接受任何生活方式干预。纳入标准是6-12岁,身高体重≥+40%或≥+30%,和增加曲线。所有参与者填写研究问卷,并在基线和12个月时采集血浆样本。结果变量将在干预组和对照组之间进行比较。
结论:如果这种生活方式干预的效果是积极的,并且具有成本效益,我们的研究对儿童肥胖的治疗和改善医疗保健系统具有重要意义。
背景:ClinicalTrials.govNCT06126679。2028年10月25日在芬兰注册。
■0009-0009-6659-5290。