Department of Epidemiology, Institute of Social Medicine, State University of Rio de Janeiro, CEP, 20550-013, Rio de Janeiro, Brazil.
Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
BMC Public Health. 2023 Jul 29;23(1):1453. doi: 10.1186/s12889-023-16356-6.
Clinical trials to treat childhood obesity show modest results, weight regain and high dropout rates. Children with obesity often live in families with habits that contribute to unhealthy weight gain. This study will test whether a family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior, can reduce excessive weight gain. The protocol promotes the intake of in natura products and water and reduces ultra-processed foods, sugar, and sodium. It encourages family lifestyle changes and physical activities, with randomized allocation to experimental and control groups. The responsible family member will be evaluated during follow-up. The control group will receive a print of the Brazilian dietary guideline.
A factorial crossover design will also allocate families to receive reduced sodium salt plus anti-inflammatory herbs and a placebo salt. Both the control and intervention groups will be randomly assigned to the sequence of both salts. The approach aims to reduce body weight expectations and evaluate salt's impact on blood pressure. It includes a 1-month intervention, 1-month washout, and 1-month intervention with monthly clinic visits and teleservice by health professionals. The primary outcomes will be the variation in the Body Mass Index (BMI) of the children. BMI and the variation in the blood pressure of the pair (child/mother or father) as well as waist circumference (WC) and waist-to-height ratio (WHtR) will also be measured.
The project will test the effectiveness of the use of the recommendations of the PHD, physical activity and a salt-reduced sodium. The results of the present study will allow the refinement of interventions aimed at the treatment of childhood obesity and may help develop guidelines for the treatment of obesity in Brazilian children.
The study is registered in the Brazilian Registry of Clinical Trials (RBR-10 mm62vs). Registered 10 February 2023.
治疗儿童肥胖的临床试验结果并不显著，体重易反弹且退出率高。肥胖儿童的家庭通常存在导致体重不健康增加的习惯。本研究将测试一种家庭干预措施，该措施采用巴西适应性行星健康饮食（PHD）和减少食物份量，同时增加身体活动和减少久坐行为，是否可以减少过度体重增加。该方案提倡摄入天然产品和水，并减少超加工食品、糖和钠的摄入。它鼓励家庭生活方式的改变和体育活动，并随机分配到实验组和对照组。在随访期间将对负责的家庭成员进行评估。对照组将收到巴西饮食指南的印刷版。
析因交叉设计还将分配家庭接受低钠盐加抗炎草药和安慰剂盐。对照组和干预组都将随机分配到两种盐的顺序。该方法旨在降低对盐的期望体重，并评估盐对血压的影响。它包括为期 1 个月的干预、1 个月的洗脱期和 1 个月的干预，每月进行诊所就诊和由健康专业人员提供远程服务。主要结果将是儿童体重指数（BMI）的变化。还将测量血压的配对（儿童/母亲或父亲）以及腰围（WC）和腰高比（WHtR）的 BMI 和变化。
该项目将测试 PHD、体育活动和低钠盐的建议的有效性。本研究的结果将允许对治疗儿童肥胖的干预措施进行改进，并可能有助于制定巴西儿童肥胖治疗指南。
该研究在巴西临床试验注册中心（RBR-10mm62vs）注册。注册于 2023 年 2 月 10 日。
