K E DuBois, D C Delgado-Díaz, M McGrievy, H Valafar, C Monroe, S Wilcox, G Turner-McGrievy
{"title":"移动饮食和运动生活方式干预（mLife）研究：预防 2 型糖尿病的远程行为减肥随机临床试验方案。","authors":"K E DuBois, D C Delgado-Díaz, M McGrievy, H Valafar, C Monroe, S Wilcox, G Turner-McGrievy","doi":"10.1016/j.cct.2024.107735","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Emerging research has examined electronic and mobile health (e/mHealth) technologies for weight loss and manage of type 2 diabetes mellitus (T2DM), but few studies have focused specifically on ways to target social support behaviors that have proven to be effective. While gamifying an mHealth behavioral weight loss intervention holds promise to promote and sustain social support, there has been very little research in this area. The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote sustained weight loss.</p><p><strong>Objective: </strong>To describe the design of the 12-month mLife study, a randomized clinical trial, which compares the differential long-term effect of a behavioral weight loss program with and without gamification among adults with overweight or obesity.</p><p><strong>Methods: </strong>Participants (target N = 240) in two consecutive cohorts were randomized to either the mLife+points or mLife group. The weight loss intervention for both groups included diet and physical activity (PA) recommendations, education, daily diet logging, visualization of PA and body weight readings captured with a wearable tracker and e-scale, and facilitation of social interaction among participants. The mLife+points group earned points for social support activities. Remote follow-up assessments of weight, anthropometric measures, diet (24 h dietary recalls), PA, social support provision, receipt and enjoyment, factors driving self-monitoring adherence and study compliance/responsiveness occurred at 6 and 12-months post-baseline.</p><p><strong>Conclusion: </strong>The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.</p><p><strong>Trial registration: </strong>This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT05176847.</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107735"},"PeriodicalIF":2.0000,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"The Mobile lifestyle intervention for food and exercise (mLife) study: Protocol of a remote behavioral weight loss randomized clinical trial for type 2 diabetes prevention.\",\"authors\":\"K E DuBois, D C Delgado-Díaz, M McGrievy, H Valafar, C Monroe, S Wilcox, G Turner-McGrievy\",\"doi\":\"10.1016/j.cct.2024.107735\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Emerging research has examined electronic and mobile health (e/mHealth) technologies for weight loss and manage of type 2 diabetes mellitus (T2DM), but few studies have focused specifically on ways to target social support behaviors that have proven to be effective. While gamifying an mHealth behavioral weight loss intervention holds promise to promote and sustain social support, there has been very little research in this area. The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote sustained weight loss.</p><p><strong>Objective: </strong>To describe the design of the 12-month mLife study, a randomized clinical trial, which compares the differential long-term effect of a behavioral weight loss program with and without gamification among adults with overweight or obesity.</p><p><strong>Methods: </strong>Participants (target N = 240) in two consecutive cohorts were randomized to either the mLife+points or mLife group. The weight loss intervention for both groups included diet and physical activity (PA) recommendations, education, daily diet logging, visualization of PA and body weight readings captured with a wearable tracker and e-scale, and facilitation of social interaction among participants. The mLife+points group earned points for social support activities. Remote follow-up assessments of weight, anthropometric measures, diet (24 h dietary recalls), PA, social support provision, receipt and enjoyment, factors driving self-monitoring adherence and study compliance/responsiveness occurred at 6 and 12-months post-baseline.</p><p><strong>Conclusion: </strong>The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.</p><p><strong>Trial registration: </strong>This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT05176847.</p>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":\" \",\"pages\":\"107735\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-11-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cct.2024.107735\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cct.2024.107735","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
The Mobile lifestyle intervention for food and exercise (mLife) study: Protocol of a remote behavioral weight loss randomized clinical trial for type 2 diabetes prevention.
Background: Emerging research has examined electronic and mobile health (e/mHealth) technologies for weight loss and manage of type 2 diabetes mellitus (T2DM), but few studies have focused specifically on ways to target social support behaviors that have proven to be effective. While gamifying an mHealth behavioral weight loss intervention holds promise to promote and sustain social support, there has been very little research in this area. The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote sustained weight loss.
Objective: To describe the design of the 12-month mLife study, a randomized clinical trial, which compares the differential long-term effect of a behavioral weight loss program with and without gamification among adults with overweight or obesity.
Methods: Participants (target N = 240) in two consecutive cohorts were randomized to either the mLife+points or mLife group. The weight loss intervention for both groups included diet and physical activity (PA) recommendations, education, daily diet logging, visualization of PA and body weight readings captured with a wearable tracker and e-scale, and facilitation of social interaction among participants. The mLife+points group earned points for social support activities. Remote follow-up assessments of weight, anthropometric measures, diet (24 h dietary recalls), PA, social support provision, receipt and enjoyment, factors driving self-monitoring adherence and study compliance/responsiveness occurred at 6 and 12-months post-baseline.
Conclusion: The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.
Trial registration: This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT05176847.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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