基于成瘾行为的数字化体重管理干预：一项多中心随机对照试验。
An addiction-based digital weight loss intervention: A multi-centre randomized controlled trial.
机构信息
Department of Pediatrics, Center for Endocrinology, Diabetes and Metabolism, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, California, USA.
Department of Medicine, Cedars-Sinai Medical Center, Research Center for Health Equity Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, USA.
出版信息
Pediatr Obes. 2023 Mar;18(3):e12990. doi: 10.1111/ijpo.12990. Epub 2022 Dec 9.
OBJECTIVE
This randomized clinical trial tested the effectiveness of an addiction-based digital weight-loss intervention, focusing on withdrawal/abstinence from self-identified problem foods, snacking and excessive amounts at meals, and discomfort displacement, with and without coaching, compared to an in-person, multi-disciplinary, care model among adolescents with obesity. We hypothesized that the digital intervention with coaching would yield greater weight loss and lower delivery burden than the standard clinical arm, and greater participant engagement than the digital arm without coaching.
METHODS
Adolescents were randomized to app intervention, with or without coaching, or in-person multidisciplinary obesity intervention for 6 months. The primary outcome was change in %BMI at weeks 12 and 24. A mixed-effects linear regression model was used to assess the association between change in %BMI and intervention arm. We were also interested in assessing delivery burden, participant engagement and evaluating the relationships between weight change and demographic characteristics, mood, executive function and eating behaviours.
RESULTS
All adolescents (n = 161; BMI ≥95th%, age 16 ± 2.5 year; 47% Hispanic, 65% female, 59% publicly insured) lost weight over 24-weeks (-1.29%, [-1.82, -0.76], p < 0.0001), with no significant weight loss difference between groups (p = 0.3). Girls lost more weight than boys, whereas binge eating behaviour at baseline was associated with increase in %BMI when controlling for other covariates. There was no association between ethnicity, mood, timing of intervention in relation to the pandemic, or executive function and change in %BMI .
CONCLUSIONS
Contrary with our hypothesis, our results showed no difference in the change in BMI status between treatment arms. Since efficacy of this digital intervention was not inferior to in-person, multi-disciplinary care, this could offer a reasonable weight management option for clinicians, based on youth and family specific characteristics, such as accessibility, resources, and communication styles.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT035008353.
目的
本随机临床试验旨在测试一种基于成瘾的数字减肥干预措施的有效性，该措施侧重于戒除/戒除自我识别的问题食物、零食和用餐时过量摄入以及不适替代物，同时提供和不提供教练指导，与肥胖青少年的面对面多学科护理模式进行比较。我们假设，带教练的数字干预措施将比标准临床组产生更大的体重减轻效果和更低的交付负担，并比不带教练的数字组产生更大的参与者参与度。
方法
将青少年随机分配到应用程序干预组，带或不带教练指导，或接受面对面的多学科肥胖干预 6 个月。主要结局是在 12 周和 24 周时 BMI 的变化百分比。采用混合效应线性回归模型评估 BMI 变化与干预组之间的关系。我们还对交付负担、参与者参与度以及体重变化与人口统计学特征、情绪、执行功能和饮食行为之间的关系进行了评估。
结果
所有青少年（n=161；BMI≥95%，年龄 16±2.5 岁；47%西班牙裔，65%女性，59%公共保险）在 24 周内体重减轻（-1.29%，[-1.82，-0.76]，p<0.0001），各组之间的体重减轻无显著差异（p=0.3）。女孩比男孩体重减轻更多，而在控制其他协变量后，基线时的暴食行为与 BMI 的增加有关。种族、情绪、干预与大流行的时间关系、执行功能与 BMI 变化之间没有关联。
结论
与我们的假设相反，我们的结果显示治疗组之间 BMI 状态的变化没有差异。由于这种数字干预措施的疗效并不逊于面对面的多学科护理，因此根据青少年和家庭的具体特点（如可及性、资源和沟通方式），这可能为临床医生提供一种合理的体重管理选择。
临床试验注册
ClinicalTrials.gov 标识符：NCT035008353。
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