基于成瘾的数字减肥干预:一项多中心随机对照试验

IF 2.7 3区医学 Q1 PEDIATRICS

Pediatric Obesity Pub Date : 2022-12-09 DOI:10.1111/ijpo.12990

Alaina P. Vidmar, Sarah J. Salvy, Choo Phei Wee, Robert Pretlow, D. Steven Fox, Jennifer K. Yee, Cambria Garell, Suzette Glasner, Steven D. Mittelman

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引用次数: 0

摘要

本随机临床试验测试了基于成瘾的数字减肥干预的有效性，重点是在有或没有指导的情况下，与面对面的多学科护理模式相比，戒断/戒断自我认定的问题食物、零食和过量膳食，以及不适转移。我们假设，与标准临床组相比，带有指导的数字干预会产生更大的体重减轻和更低的分娩负担，并且比没有指导的数字组有更高的参与者参与度。方法将青少年随机分为app干预组、有指导组、无指导组和面对面多学科肥胖干预组，为期6个月。主要终点是12周和24周时%BMIp95的变化。采用混合效应线性回归模型评估%BMIp95变化与干预组之间的关系。我们还对评估分娩负担、参与者参与度以及评估体重变化与人口特征、情绪、执行功能和饮食行为之间的关系感兴趣。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)，组间体重减轻无显著差异(p = 0.3)。女孩比男孩减重更多，而在控制其他协变量的情况下，基线时的暴食行为与%BMIp95的增加有关。种族、情绪、与大流行相关的干预时间或执行功能与%BMIp95的变化之间没有关联。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。由于这种数字干预的效果并不逊于面对面的多学科护理，因此可以根据青少年和家庭的具体特征，如可及性、资源和沟通方式，为临床医生提供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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An addiction-based digital weight loss intervention: A multi-centre randomized controlled trial

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_p95 at weeks 12 and 24. A mixed-effects linear regression model was used to assess the association between change in %BMI_p95 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_p95 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_p95.

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

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来源期刊

Pediatric Obesity PEDIATRICS-

CiteScore

7.30

自引率

5.30%

发文量

117

审稿时长

6-12 weeks

期刊介绍： Pediatric Obesity is a peer-reviewed, monthly journal devoted to research into obesity during childhood and adolescence. The topic is currently at the centre of intense interest in the scientific community, and is of increasing concern to health policy-makers and the public at large. Pediatric Obesity has established itself as the leading journal for high quality papers in this field, including, but not limited to, the following: Genetic, molecular, biochemical and physiological aspects of obesity – basic, applied and clinical studies relating to mechanisms of the development of obesity throughout the life course and the consequent effects of obesity on health outcomes Metabolic consequences of child and adolescent obesity Epidemiological and population-based studies of child and adolescent overweight and obesity Measurement and diagnostic issues in assessing child and adolescent adiposity, physical activity and nutrition Clinical management of children and adolescents with obesity including studies of treatment and prevention Co-morbidities linked to child and adolescent obesity – mechanisms, assessment, and treatment Life-cycle factors eg familial, intrauterine and developmental aspects of child and adolescent obesity Nutrition security and the "double burden" of obesity and malnutrition Health promotion strategies around the issues of obesity, nutrition and physical activity in children and adolescents Community and public health measures to prevent overweight and obesity in children and adolescents.