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Active, Not Recruiting

NCT Number: NCT06223386

Total Lifestyle Reconstruction for Body Weight Control and Maintenance

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Biomedical Sciences, Academia Sinica

Taipei, 115, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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

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.

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

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.

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

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.

Primary outcomes

  1. 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.

  2. Change from baseline in fat percent at Month 3 and 6.

    Time frame: Baseline, Month 3 and 6

  3. 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:

    • Whole grains and starchy vegetables
    • Protein foods: soybeans, fish, eggs, and meat
    • Vegetables
    • Fruits
    • Dairy
    • Oils, nuts & seeds.

Secondary outcomes

  1. Change from baseline in physical activity at Month 3 and 6.

    Time frame: Baseline, Month 3 and 6

  2. Change from baseline in sleep quality at Month 3 and 6.

    Time frame: Baseline, Month 3 and 6

Sponsors and collaborators

Lead sponsor

Academia Sinica, Taiwan

Other

Collaborators

  • National Health Research Institutes, Taiwan

Registry information

Official study title

Total Lifestyle Reconstruction for Body Weight Control and Maintenance: an On-line Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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