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临床试验/NCT06223386
NCT06223386进行中(未招募)不适用

Total Lifestyle Reconstruction for Body Weight Control and Maintenance: an On-line Randomized Controlled Trial

Academia Sinica, Taiwan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Change from baseline in diet quality at Month 3 and 6.

研究概览

简要总结

Obesity stands as a significant health concern of the 21st century. The prevalence of obesity is steadily rising worldwide, and Taiwan is no exception, with nearly four to five out of ten individuals facing issues of overweight or obesity. Additionally, approximately 1.5% of adults suffer from morbid obesity. Presently, lifestyle interventions focusing on body control have shown limited success in maintaining an ideal weight and body composition, and they are predominantly applied within clinical settings for managing morbidly obese patients.

In response to the transformations brought about by the 3C era in connecting with the public, an effective online intervention approach holds promising potential but still requires development and validation. This project endeavors to revolve around "cultivating a healthy lifestyle" by creating educational materials on weight reduction. These materials will encompass various aspects such as dietary habits, physical activity, and daily routines, all designed to impart online lifestyle education. To facilitate the intervention, the investigators plan to employ the application "Cofit" developed by the Cofit Healthcare Inc., targeting individuals with weight reduction needs. Furthermore, the investigators aim to collect research data for the analysis of intervention effectiveness.

Over a three to six-month intervention period, the research participants will receive multifaceted lifestyle education through the online app. Certified nutritionists, trained under the program, will interact with the participants online, guiding them to make changes in their diet, physical activity, and daily routines. The ultimate goal is to help the participants achieve effective weight reduction and maintain a healthy body weight in the long term.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI between 24 and 35

排除标准

  • hospitalization
  • pregnancy
  • depression
  • currently taking weight loss drugs
  • unwilling to give up meal replacement for weight loss
  • unable to cooperate with the data collection and intervention guide of this study
  • stage III kidney disease or above
  • taking medication
  • participation in previous weight loss courses of Qunjian Technology Company

结局指标

主要结局

Change from baseline in diet quality at Month 3 and 6.

时间窗: Baseline, Month 3 and 6

Diet quality is estimated according to the daily intake of nutrients and the distribution of the six food groups, with a qualified food frequency questionnaire. The six food groups include: 1. Whole grains and starchy vegetables 2. Protein foods: soybeans, fish, eggs, and meat 3. Vegetables 4. Fruits 5. Dairy 6. Oils, nuts \& seeds.

Achievement rate of healthy body weight at Month 3 and 6.

时间窗: Baseline, Month 3 and 6

The number of participants whose weight will be reduced to within the range of a personal BMI equal to 22 among all participants.

Change from baseline in fat percent at Month 3 and 6.

时间窗: Baseline, Month 3 and 6

次要结局

  • Change from baseline in physical activity at Month 3 and 6.(Baseline, Month 3 and 6)
  • Change from baseline in sleep quality at Month 3 and 6.(Baseline, Month 3 and 6)

研究者

发起方
Academia Sinica, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Harn Pan

Distinguished Research Fellow

Academia Sinica, Taiwan

研究点 (2)

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