Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06630663

A Wearable Device and AI-Supported Diet and Exercise Intervention

Led by National Taiwan University Hospital · Updated on 2026-03-25

120

Participants Needed

2

Research Sites

124 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study implemented a personalized 6-month diet and exercise program to promote weight loss. Participants were recruited from outpatient clinics at the Department of Family Medicine, National Taiwan University Hospital. Overweight and obese adults were eligible, defined as follows: overweight (BMI 24-27 kg/m²), mild obesity (BMI 27-30 kg/m²), moderate obesity (BMI 30-35 kg/m²), and severe obesity (BMI ≥ 35 kg/m²). Exclusion criteria included recent weight changes exceeding 3%, a history of bariatric surgery, untreated psychiatric disorders, or medications affecting body weight. Study design: Of the 171 subjects screened, 29 were excluded due to BMI criteria, leaving 142 participants for baseline body composition and biochemical analysis. Of these, 98 joined the 6-month weight loss program, while 44 remained in the control group. Participants were divided into two groups: one followed a standard diet and exercise program, while the other used a wearable device and AI apps alongside the same program. The wearable device tracked steps, heart rate, and estimated calories burned. Outpatient visits occurred at weeks 0, 12, and 24, with additional diet and exercise education. Phone consultations at weeks 2, 4, and 8 provided 10-minute guidance sessions from case managers. Weight loss medications were not permitted during the study. Data collection: Weight, height, and blood pressure were measured using standard scales and sphygmomanometers. Waist circumference was measured by a trained operator, and bioelectrical impedance analysis was used to assess skeletal muscle, fat mass, and body fat percentage. Blood samples were collected after an 8-hour fast to measure glucose, cholesterol, and triglycerides. Insulin levels were measured, and HOMA-IR was used to assess insulin resistance. Galectin-1 levels were measured using an ELISA kit. Measurements were taken at baseline and at the end of the intervention (week 24). Diet and exercise intervention: All participants followed a standard diet and exercise program. Those opting for the wearable device aimed for 7,500 steps per day, following World Health Organization recommendations for 150 minutes of moderate aerobic activity per week. Dietary education included caloric intake calculations and Mediterranean diet principles. Participants using wearable devices logged daily steps and food intake, which was uploaded to a health management platform. Case managers provided lifestyle coaching through the platform.

CONDITIONS

Official Title

A Wearable Device and AI-Supported Diet and Exercise Intervention

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 20 years of age
  • Body mass index (BMI) of 24 kg/m2 or higher with one or more obesity-related conditions such as hypertension, diabetes, high cholesterol, sleep apnea, or fatty liver disease
  • Able to use a wearable device and smartphone app
  • Able to sign informed consent after study explanation
Not Eligible

You will not qualify if you...

  • Unable to complete self-administered questionnaires
  • Unable to complete body composition tests, hand grip test, or blood sampling
  • Unable to attend clinic visits at scheduled times

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

National Taiwan University Hospital

Taipei, Taipei, Taiwan, 100

Actively Recruiting

2

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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Research Team

C

CW LU, A.P.

CONTACT

K

KC Huang, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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