Clinical trial NCT06223386: Total Lifestyle Reconstruction for Body Weight Control and Maintenance
Official title: Total Lifestyle Reconstruction for Body Weight Control and Maintenance: an On-line Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Academia Sinica, Taiwan
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
First posted: 2024-01-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* BMI between 24 and 35

Exclusion Criteria:

* cancer
* 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
* diabetes
* taking medication
* participation in previous weight loss courses of Qunjian Technology Company

Primary outcomes:
measure: Achievement rate of healthy body weight at Month 3 and 6.
timeFrame: Baseline, Month 3 and 6
measure: Change from baseline in fat percent at Month 3 and 6.
timeFrame: Baseline, Month 3 and 6
measure: Change from baseline in diet quality at Month 3 and 6.
timeFrame: Baseline, Month 3 and 6
Secondary outcomes:
measure: Change from baseline in physical activity at Month 3 and 6.
timeFrame: Baseline, Month 3 and 6
measure: Change from baseline in sleep quality at Month 3 and 6.
timeFrame: Baseline, Month 3 and 6
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Biomedical Sciences, Academia Sinica
Study officials:
affiliation: Institute of Biomedical Sciences, Academia Sinica
name: Wen-Harn Pan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: