Marthe Isaksen Aukan, Maria Arlèn Larsen, Tone Iren Melan, Øyvind Olav Salvesen
{"title":"在减肥之外：初级卫生保健机构中超重和肥胖个体行为改变和心理健康的数字治疗——一项随机对照试点研究","authors":"Marthe Isaksen Aukan, Maria Arlèn Larsen, Tone Iren Melan, Øyvind Olav Salvesen","doi":"10.3389/fdgth.2025.1671649","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>Mobile health (mHealth) through digital therapeutics (DTx) offer a promising approach to obesity management. This study evaluated the effectiveness of the Lifeness DTx for obesity care and its effect on anthropometrics, reward-related eating behaviors and quality of life in individuals with overweight and obesity within a community-based healthcare setting.</p><p><strong>Methods: </strong>A 12-week randomized controlled trial was conducted. Adults (BMI ≥ 27 kg/m<sup>2</sup>, and central obesity) were recruited from municipal Healthy Life Centers in Norway. The intervention group (IG) received standard care plus full DTx app with program functionality and digital follow-up, whereas the control group (CG) received standard care with limited app functions and no DTx program. Outcome variables were measured at baseline and after 12 weeks.</p><p><strong>Results: </strong>No significant changes in body weight, or differences between groups were observed at W12. The IG showed reductions in waist circumference (-3.4 cm, <i>p</i> = 0.008, <i>d</i> = -0.926), waist-to-height ratio (-0.02, <i>p</i> = 0.008, <i>d</i> = -0.929), improvements on hedonic eating behavior, indicated by reduced disinhibition (-1.6, <i>p</i> = 0.013, <i>d</i> = -0.907), as well as increased quality of life (+5.0, <i>p</i> = 0.019, <i>d</i> = 0.899). Both groups increased self-esteem (IG +9.8, <i>p</i> = 0.018, <i>d</i> = 0.911, and CG +12, <i>p</i> = 0.050, <i>d</i> = 0.838).</p><p><strong>Conclusion: </strong>The DTx intervention was associated with improvements in central adiposity, reward-related eating behaviors, and psychological well-being beyond weight loss. These findings provide preliminary evidence that digital therapeutics may represent a feasible and scalable approach to support personalized obesity care in primary healthcare settings. Larger, adequately powered trials are needed to confirm these results.</p><p><strong>Clinical trial registration: </strong>clinicaltrials.gov, identifier NCT06667843 (Initial Release: 10/15/2024).</p>","PeriodicalId":73078,"journal":{"name":"Frontiers in digital health","volume":"7 ","pages":"1671649"},"PeriodicalIF":3.2000,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12479526/pdf/","citationCount":"0","resultStr":"{\"title\":\"Beyond weight loss: digital therapeutic for behavioral change and psychological well-being for individuals with overweight and obesity in a primary healthcare setting-A randomized controlled pilot study.\",\"authors\":\"Marthe Isaksen Aukan, Maria Arlèn Larsen, Tone Iren Melan, Øyvind Olav Salvesen\",\"doi\":\"10.3389/fdgth.2025.1671649\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>Mobile health (mHealth) through digital therapeutics (DTx) offer a promising approach to obesity management. This study evaluated the effectiveness of the Lifeness DTx for obesity care and its effect on anthropometrics, reward-related eating behaviors and quality of life in individuals with overweight and obesity within a community-based healthcare setting.</p><p><strong>Methods: </strong>A 12-week randomized controlled trial was conducted. Adults (BMI ≥ 27 kg/m<sup>2</sup>, and central obesity) were recruited from municipal Healthy Life Centers in Norway. The intervention group (IG) received standard care plus full DTx app with program functionality and digital follow-up, whereas the control group (CG) received standard care with limited app functions and no DTx program. Outcome variables were measured at baseline and after 12 weeks.</p><p><strong>Results: </strong>No significant changes in body weight, or differences between groups were observed at W12. The IG showed reductions in waist circumference (-3.4 cm, <i>p</i> = 0.008, <i>d</i> = -0.926), waist-to-height ratio (-0.02, <i>p</i> = 0.008, <i>d</i> = -0.929), improvements on hedonic eating behavior, indicated by reduced disinhibition (-1.6, <i>p</i> = 0.013, <i>d</i> = -0.907), as well as increased quality of life (+5.0, <i>p</i> = 0.019, <i>d</i> = 0.899). Both groups increased self-esteem (IG +9.8, <i>p</i> = 0.018, <i>d</i> = 0.911, and CG +12, <i>p</i> = 0.050, <i>d</i> = 0.838).</p><p><strong>Conclusion: </strong>The DTx intervention was associated with improvements in central adiposity, reward-related eating behaviors, and psychological well-being beyond weight loss. These findings provide preliminary evidence that digital therapeutics may represent a feasible and scalable approach to support personalized obesity care in primary healthcare settings. Larger, adequately powered trials are needed to confirm these results.</p><p><strong>Clinical trial registration: </strong>clinicaltrials.gov, identifier NCT06667843 (Initial Release: 10/15/2024).</p>\",\"PeriodicalId\":73078,\"journal\":{\"name\":\"Frontiers in digital health\",\"volume\":\"7 \",\"pages\":\"1671649\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-09-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12479526/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Frontiers in digital health\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3389/fdgth.2025.1671649\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in digital health","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3389/fdgth.2025.1671649","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0
摘要
目的：通过数字治疗（DTx）的移动医疗（mHealth）为肥胖管理提供了一种有前途的方法。本研究评估了Lifeness DTx对肥胖护理的有效性及其对社区医疗保健机构中超重和肥胖个体的人体测量学、奖励相关饮食行为和生活质量的影响。方法：采用为期12周的随机对照试验。成人（BMI≥27 kg/m2，中心性肥胖）从挪威市政健康生活中心招募。干预组（IG）接受标准治疗加上完整的DTx应用程序，具有程序功能和数字随访，而对照组（CG）接受标准治疗，应用程序功能有限，没有DTx程序。在基线和12周后测量结果变量。结果：W12时体重无明显变化，各组间无明显差异。IG显示腰围减少（-3.4 cm, p = 0.008, d = -0.926），腰高比减少（-0.02,p = 0.008, d = -0.929），享乐性饮食行为改善（-1.6,p = 0.013, d = -0.907），生活质量提高（+5.0,p = 0.019, d = 0.899）。两组自尊水平均提高（IG +9.8, p = 0.018, d = 0.911, CG +12, p = 0.050, d = 0.838）。结论：DTx干预与中枢性肥胖、奖励相关饮食行为和心理健康的改善有关，而不仅仅是体重减轻。这些发现提供了初步证据，表明数字治疗可能是一种可行且可扩展的方法，可支持初级卫生保健机构的个性化肥胖护理。需要更大规模、更有力的试验来证实这些结果。临床试验注册：clinicaltrials.gov，标识符NCT06667843（最初发布：10/15/2024）。
Beyond weight loss: digital therapeutic for behavioral change and psychological well-being for individuals with overweight and obesity in a primary healthcare setting-A randomized controlled pilot study.
Objective: Mobile health (mHealth) through digital therapeutics (DTx) offer a promising approach to obesity management. This study evaluated the effectiveness of the Lifeness DTx for obesity care and its effect on anthropometrics, reward-related eating behaviors and quality of life in individuals with overweight and obesity within a community-based healthcare setting.
Methods: A 12-week randomized controlled trial was conducted. Adults (BMI ≥ 27 kg/m2, and central obesity) were recruited from municipal Healthy Life Centers in Norway. The intervention group (IG) received standard care plus full DTx app with program functionality and digital follow-up, whereas the control group (CG) received standard care with limited app functions and no DTx program. Outcome variables were measured at baseline and after 12 weeks.
Results: No significant changes in body weight, or differences between groups were observed at W12. The IG showed reductions in waist circumference (-3.4 cm, p = 0.008, d = -0.926), waist-to-height ratio (-0.02, p = 0.008, d = -0.929), improvements on hedonic eating behavior, indicated by reduced disinhibition (-1.6, p = 0.013, d = -0.907), as well as increased quality of life (+5.0, p = 0.019, d = 0.899). Both groups increased self-esteem (IG +9.8, p = 0.018, d = 0.911, and CG +12, p = 0.050, d = 0.838).
Conclusion: The DTx intervention was associated with improvements in central adiposity, reward-related eating behaviors, and psychological well-being beyond weight loss. These findings provide preliminary evidence that digital therapeutics may represent a feasible and scalable approach to support personalized obesity care in primary healthcare settings. Larger, adequately powered trials are needed to confirm these results.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
