A Wearable Device and AI-Supported Diet and Exercise Intervention
A legfontosabb adatok
- Ki végzi
- National Taiwan University Hospital
- Hol
- Taipei (Tajvan)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 120 fő, tervezett
- Kezdés
- 2025. aug. 10.
- Várható befejezés
- 2027. dec. 31.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- A Wearable Device and AI-Supported Diet and Exercise intervention
- standard care
- A regiszteradat frissítve
- 2026. szeptember 15.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan túlsúlyos vagy elhízott felnőtteket keres, akiknek van hozzá kapcsolódó egészségi problémájuk is, és tudnak viselhető eszközt és alkalmazást használni.
- Életkor
- 20 éves vagy idősebb.
- Nem
- Bármely nem részt vehet.
- A betegség stádiuma
- 24 kg/m2 vagy magasabb testtömegindex (BMI), és legalább egy elhízással összefüggő betegség, például magas vérnyomás, cukorbetegség, magas vérzsírszint, alvási apnoé vagy nem alkoholos zsírmáj.
A részvétel fő kizáró okai
- Nem tudja kitölteni az önállóan kitöltendő kérdőíveket
- Nem tudja elvégeztetni a testösszetétel-vizsgálatokat, a kézi szorítóerő-tesztet és a vérvételt
- Nem tud a megadott időpontban visszatérni a rendelőbe
A regiszter feltételei, szó szerint
Mind a 7 feltétel megnézéseKevesebb
Ki vehet részt
- At least 20 years of age
- BMI ≥24 kg/m2 plus one or more obesity-related comorbidities such as hypertension, diabetes, hyperlipidemia, sleep apnea syndrome, or nonalcoholic fatty liver disease
- Able to use a wearable device and an app
- Able to sign the informed consent form after receiving a detailed explanation of the study
Ki nem vehet részt
- Unable to finish the self-administered questionnaires
- Unable to complete body composition assessment (bioimpedance analysis and abdominal echo), hand grip test, and blood sampling
- Unable to return to our clinics at the scheduled time
Helyszínek itt: Tajvan
- National Taiwan University HospitalTaipei, TajvanContact: CHIAWEN LU, ASSOCIATED PROFESSORRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- standard careMár használt kezelés, összehasonlításként
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.
- A Wearable Device and AI-Supported Diet and Exercise interventionA vizsgált kezelés
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.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Effectiveness of a Wearable Device and AI-Supported Diet and Exercise Intervention in Obese Adults-a Quasi-experimental Design Study
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
- A regiszteradat frissítve
- 2026. szeptember 15.