Total Lifestyle Reconstruction for Body Weight Control and Maintenance
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedStudy Start
First participant enrolled
February 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedAugust 13, 2024
August 1, 2024
7 months
January 12, 2024
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Achievement rate of healthy body weight at 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.
Baseline, Month 3 and 6
Change from baseline in fat percent at Month 3 and 6.
Baseline, Month 3 and 6
Change from baseline in diet quality at 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.
Baseline, Month 3 and 6
Secondary Outcomes (2)
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
Study Arms (4)
Traditional model
PLACEBO COMPARATORDesigned course A with 3-month consultation with the dietitians
Multi-oriented lifestyle education
EXPERIMENTALDesigned course B with 3-month consultation with the dietitians
Multi-oriented lifestyle education with dietary assessment
EXPERIMENTALDesigned 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
EXPERIMENTALDesigned course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians
Interventions
Educational materials on weight reduction will be provided at the beginning of the 3-month intervention. Participants can consult with the dietitian via the APP on their mobile phones during the intervention period. These materials will encompass dietary and physical activity guidelines by the government in Taiwan.
Educational materials on weight reduction will be provided every weekday for 8 weeks. Participants can consult with the dietitian via the APP on their mobile phones during the 3-month intervention period. These materials will encompass various aspects such as dietary habits, physical activity, and daily routines, all designed to impart online lifestyle education.
Educational materials on weight reduction will be provided every weekday for 8 weeks. Participants can consult with the dietitian via the APP on their mobile phones during the 3-month intervention period. These materials will encompass various aspects such as dietary habits, physical activity, and daily routines, all designed to impart online lifestyle education. In addition, dietitians assess participants' daily diet for 3 months.
Educational materials on weight reduction will be provided every weekday for 8 weeks. Participants can consult with the dietitian via the APP on their mobile phones during the 6-month intervention period. These materials will encompass various aspects such as dietary habits, physical activity, and daily routines, all designed to impart online lifestyle education. In addition, dietitians assess participants' daily diet for 6 months.
Eligibility Criteria
You may qualify if:
- BMI between 24 and 35
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Biomedical Sciences, Academia Sinica
Taipei, 115, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wen-Harn Pan, Ph.D.
Institute of Biomedical Sciences, Academia Sinica
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Research Fellow
Study Record Dates
First Submitted
January 12, 2024
First Posted
January 25, 2024
Study Start
February 26, 2024
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
August 13, 2024
Record last verified: 2024-08