Total Lifestyle Reconstruction for Body Weight Control and Maintenance

January 23, 2024 updated by: Wen-Harn Pan, Academia Sinica, Taiwan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Traditional model
Designed course A with 3-month consultation with the dietitians
Behavioral: 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.
Experimental: Multi-oriented lifestyle education
Designed course B with 3-month consultation with the dietitians
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.
Experimental: 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
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.
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3 and 6
Change from baseline in fat percent at Month 3 and 6.
Time Frame: Baseline, Month 3 and 6
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.
Baseline, Month 3 and 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in physical activity at Month 3 and 6.
Time Frame: Baseline, Month 3 and 6
Baseline, Month 3 and 6
Change from baseline in sleep quality at Month 3 and 6.
Time Frame: Baseline, Month 3 and 6
Baseline, Month 3 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academia Sinica, Taiwan

Collaborators

National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 22, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS-IRB-BM-23059
  • EC1121001-E (Other Identifier: NHRI IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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