Overweight and ObesityNCT06223386
Total Lifestyle Reconstruction for Body Weight Control and Maintenance
A study testing Designed on-line course A with 3-month consultation with the dietitian, Designed on-line course B with 3-month consultation with the dietitian and Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians in people with Overweight and Obesity, run by Academia Sinica, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Designed on-line course A with 3-month consultation with the dietitian, Designed on-line course B with 3-month consultation with the dietitian and Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Feb 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 24 and 35
Who cannot join
- cancer
- hospitalization
- pregnancy
- depression
- currently taking weight loss drugs
- unwilling to give up meal replacement for weight loss
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Total Lifestyle Reconstruction for Body Weight Control and Maintenance: an On-line Randomized Controlled Trial
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.
- Conditions
- Overweight and Obesity
- Being tested
- Designed on-line course A with 3-month consultation with the dietitian, Designed on-line course B with 3-month consultation with the dietitian, Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians, Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Designed on-line course A with 3-month consultation with the dietitianBehavioural
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.
Designed on-line course B with 3-month consultation with the dietitianBehavioural
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.
Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitiansBehavioural
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.
Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitiansBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional model | Placebo comparator | Designed course A with 3-month consultation with the dietitians Receives: Behavioral: Designed on-line course A with 3-month consultation with the dietitian |
| Multi-oriented lifestyle education | Experimental | Designed course B with 3-month consultation with the dietitians Receives: Behavioral: Designed on-line course B with 3-month consultation with the dietitian |
| Multi-oriented lifestyle education with dietary assessment | Experimental | Designed course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians Receives: 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 | Designed course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians Receives: Behavioral: Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 3 and 6
Change from baseline in fat percent at Month 3 and 6.
Measured: 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:
- Whole grains and starchy vegetables
- Protein foods: soybeans, fish, eggs, and meat
- Vegetables
- Fruits
- Dairy
- Oils, nuts \& seeds.
Measured: Baseline, Month 3 and 6
Secondary outcomes (2)
Change from baseline in physical activity at Month 3 and 6.
Measured: Baseline, Month 3 and 6
Change from baseline in sleep quality at Month 3 and 6.
Measured: Baseline, Month 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start26 Feb 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Principal investigator, Wen-Harn Pan, Academia Sinica, Taiwan
- Investigators
- Wen-Harn Pan, Ph.D., Principal investigator, Institute of Biomedical Sciences, Academia Sinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223386
- Sponsor's protocol ID
- AS-IRB-BM-23059
- Other IDs
- EC1121001-E
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Lifestyle Reconstruction for Body Weight Control and Maintenance: an On-line Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06223386
- Acronym / sponsor ID
- AS-IRB-BM-23059
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional model | Placebo comparator | Behavioral: Designed on-line course A with 3-month consultation with the dietitianDesigned course A with 3-month consultation with the dietitians |
| Multi-oriented lifestyle education | Experimental | Behavioral: Designed on-line course B with 3-month consultation with the dietitianDesigned course B with 3-month consultation with the dietitians |
| Multi-oriented lifestyle education with dietary assessment | Experimental | Behavioral: Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitiansDesigned 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 | Behavioral: Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitiansDesigned course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI between 24 and 35
Key exclusion criteria (11 listed)
- cancer
- hospitalization
- pregnancy
- depression
- currently taking weight loss drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Designed on-line course A with 3-month consultation with the dietitianEducational 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. | Behavioural | Traditional model |
| Designed on-line course B with 3-month consultation with the dietitianEducational 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. | Behavioural | Multi-oriented lifestyle education |
| Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitiansEducational 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. | Behavioural | Multi-oriented lifestyle education with dietary assessment |
| Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitiansEducational 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. | Behavioural | Multi-oriented lifestyle education with longer period of dietary assessment |
Primary outcome
Achievement rate of healthy body weight at Month 3 and 6.
Time frame: 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.
Time frame: Baseline, Month 3 and 6
Change from baseline in diet quality at Month 3 and 6.
Time frame: 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.
2 secondary outcomes
Change from baseline in physical activity at Month 3 and 6.
Time frame: Baseline, Month 3 and 6
Change from baseline in sleep quality at Month 3 and 6.
Time frame: Baseline, Month 3 and 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Harn Pan, Ph.D. principal investigator
Institute of Biomedical Sciences, Academia Sinica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Designed on-line course A with 3-month consultation with the dietitian, Designed on-line course B with 3-month consultation with the dietitian and Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians in people with Overweight and Obesity, run by Academia Sinica, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement rate of healthy body weight at Month 3 and 6. (time frame: Baseline, Month 3 and 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.