Total Lifestyle Reconstruction for Body Weight Control and Maintenance

Not Applicable

Active, not recruiting

• Conditions: Overweight and Obesity
• Interventions: Behavioral: Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians; 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 A with 3-month consultation with the dietitian; Behavioral: Designed on-line course B with 3-month consultation with the dietitian

• Registration Number: NCT06223386
• Lead Sponsor: Academia Sinica, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-01-25
• Study Start: 2024-02-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-oriented lifestyle education with dietary assessment	Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians	Designed 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	Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians	Designed course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians
Traditional model	Designed on-line course A with 3-month consultation with the dietitian	Designed course A with 3-month consultation with the dietitians
Multi-oriented lifestyle education	Designed on-line course B with 3-month consultation with the dietitian	Designed course B with 3-month consultation with the dietitians

Primary Outcome Measures

Name	Time	Method
Change from baseline in diet quality at Month 3 and 6.	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.	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.	Baseline, Month 3 and 6

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Biomedical Sciences, Academia Sinica; 🇨🇳 Taipei, Taiwan