Total Lifestyle Reconstruction for Body Weight Control and Maintenance

NCT ID: NCT06223386

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Traditional model

Designed course A with 3-month consultation with the dietitians

Group Type PLACEBO_COMPARATOR

Designed on-line course A with 3-month consultation with the dietitian

Intervention Type BEHAVIORAL

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.

Multi-oriented lifestyle education

Designed course B with 3-month consultation with the dietitians

Group Type EXPERIMENTAL

Designed on-line course B with 3-month consultation with the dietitian

Intervention Type BEHAVIORAL

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.

Multi-oriented lifestyle education with dietary assessment

Designed course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians

Group Type EXPERIMENTAL

Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians

Intervention Type BEHAVIORAL

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.

Multi-oriented lifestyle education with longer period of dietary assessment

Designed course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians

Group Type EXPERIMENTAL

Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians

Intervention Type BEHAVIORAL

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.

Interventions

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Designed on-line course A with 3-month consultation with the dietitian

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.

Intervention Type BEHAVIORAL

Designed on-line course B with 3-month consultation with the dietitian

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.

Intervention Type BEHAVIORAL

Designed on-line course B with 3-month consultation with the dietitians + 3-month daily dietary assessment by the dietitians

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.

Intervention Type BEHAVIORAL

Designed on-line course B with 6-month consultation with the dietitians + 6-month daily dietary assessment by the dietitians

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role collaborator

Academia Sinica, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Wen-Harn Pan

Distinguished Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wen-Harn Pan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Biomedical Sciences, Academia Sinica

Locations

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Institute of Biomedical Sciences, Academia Sinica

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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EC1121001-E

Identifier Type: OTHER

Identifier Source: secondary_id

AS-IRB-BM-23059

Identifier Type: -

Identifier Source: org_study_id

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