A Wearable Device and AI-Supported Diet and Exercise Intervention

NCT06630663 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-25

No results posted yet for this study

Summary

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

  • Obesity and Obesity-related Medical Conditions

Interventions

BEHAVIORAL

A Wearable Device and AI-Supported Diet and Exercise intervention

The standard dietary education encompasses instruction on the calculation of total caloric intake and emphasizes the principles of the Mediterranean diet. Tailored dietary concepts are developed based on individual patient habits to give practical advice. Each participant who chose an extra wearable device downloaded the APP to connect with the health management platform. User interface of the health management platform collected data on the number of steps walked, distance, and heart rate spontaneously. Participants recorded a dietary diary every day with a smartphone APP. All collected information was uploaded to the health management platform, too. The well-trained case managers offered a platform to coach the participants to set-up a better self-managed lifestyle modification through strategies of emphasize reminders, tracking / monitoring/ feedback and goals / rewards.

BEHAVIORAL

standard care

The standard dietary education encompasses instruction on the calculation of total caloric intake and emphasizes the principles of the Mediterranean diet. Tailored dietary concepts are developed based on individual patient habits to give practical advice. Each participant who chose an extra wearable device downloaded the APP to connect with the health management platform. User interface of the health management platform collected data on the number of steps walked, distance, and heart rate spontaneously. Participants recorded a dietary diary every day with a smartphone APP. All collected information was uploaded to the health management platform, too. The well-trained case managers offered a platform to coach the participants to set-up a better self-managed lifestyle modification through strategies of emphasize reminders, tracking / monitoring/ feedback and goals / rewards.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • CW LU, A.P. · National Taiwan University Hosital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-10
Primary Completion
2027-01-10
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630663 on ClinicalTrials.gov