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Total Lifestyle Reconstruction for Body Weight Control and Maintenance

A

Academia Sinica, Taiwan

Status

Active, not recruiting

Conditions

Overweight and Obesity

Treatments

Behavioral: Designed on-line course A with 3-month consultation with the dietitian
Behavioral: Designed on-line course B with 3-month consultation with the dietitian
Behavioral: Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians
Behavioral: Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians

Study type

Interventional

Funder types

Other

Identifiers

NCT06223386
EC1121001-E (Other Identifier)
AS-IRB-BM-23059

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups, including a placebo group

Traditional model
Placebo Comparator group
Description:
Designed course A with 3-month consultation with the dietitians
Treatment:
Behavioral: Designed on-line course A with 3-month consultation with the dietitian
Multi-oriented lifestyle education
Experimental group
Description:
Designed course B with 3-month consultation with the dietitians
Treatment:
Behavioral: Designed on-line course B with 3-month consultation with the dietitian
Multi-oriented lifestyle education with dietary assessment
Experimental group
Description:
Designed course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians
Treatment:
Behavioral: Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians
Multi-oriented lifestyle education with longer period of dietary assessment
Experimental group
Description:
Designed course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians
Treatment:
Behavioral: Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians

Trial contacts and locations

1

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Central trial contact

Wen-Harn Pan, Ph.D.

Data sourced from clinicaltrials.gov

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