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A Novel Intervention for Weight Loss in Young Adults

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06230744 ist eine interventionsstudie zur Untersuchung von Gewichtsverlust und hat den Status offene rekrutierung. Die Studie startete am 10. September 2024 und soll 140 Teilnehmer aufnehmen. Durchgeführt von Universität von Chicago ist der Abschluss für 31. August 2028 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 17. November 2025 aktualisiert.
Kurzbeschreibung
Obesity and cardiometabolic risks are significant public health issues, with about two-thirds of U.S. adults overweight or obese. Weight loss can prevent these health problems, but current lifestyle interventions have limited success. New, effective strategies are needed to address this rising issue at the population level. The goal of this clinical trial is to investigate how a behavioral intervention combined with technology impacts weight loss in young adults. The main questions it aims to answer are:

• How does the combination of behavioral intervention and technology influence weight loss in young adults?

Ausführliche Beschreibung
The study team is seeking volunteers to participate in a research study to help better understand how a behavioral intervention combined with technology may impact weight loss. Participation will span approximately 6 months. Participants will be required to attend up to 5 visits at the University of Chicago. Those visits will include daytime visits to a clinic involving fasted blood draws and completion of surveys. During the study, participants will regularly record their weight using a digital scale, input their daily food intake into a smartphone app, and wear a wrist activity monitor to track their physical activity. Participants will also be paired with a trained coach to guide and assist their progress over their 6 months of participation.
Offizieller Titel

A Novel Intervention for Weight Loss in Young Adults

Erkrankungen
Gewichtsverlust
Weitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2024-09-10
Zuletzt aktualisiert
2025-11-17
Studienende (vorauss.)
2028-08-31
Geplante Rekrutierung
140
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
AndereLifestyle Intervention
Diet and exercise coaching
Lebensstil
All participants will receive diet and exercise goals and coaching.
ExperimentellLifestyle Intervention II
Diet and exercise coaching
Lifestyle II
All participants will receive diet and exercise goals and coaching.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Weight loss
Change in weight \[kg\] at 6 months. Weight will be measured by research staff during each visit in the morning in duplicate in the fasted state after voiding using calibrated digital scales, wearing a hospital gown.
Baseline and 6 months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • Overweight or obese (BMI 25.5- 34.9 kg/m2) men and women
  • Ages 18 to 40 years
  • Weight stable (no change >25 lbs in the past 3 months)
  • Owns a smartphone and willing to install the study app

  • Presence of obstructive sleep apnea or history of any other sleep disorder.
  • Irregular menses, menopausal symptoms or post-menopausal, currently pregnant, trying to get pregnant or nursing
  • Regular travel across time zones
  • Subjects who are currently following a weight loss regimen or any other special diet or exercise programs
  • Increased fractional lean body mass (e.g., athletes)
  • Unable to walk, using an assistive device for mobility, or any contraindications to exercise
  • Diabetes
  • Claustrophobia
  • Excessive alcohol (>2 drinks/day) or caffeine (>300mg/day) intake, regular nicotine use, substance abuse.
  • Abnormal findings on screening blood testing.
  • Participants taking any prescription, over-the-counter drugs/supplements that can affect sleep or weight.
  • Major psychiatric or any eating disorder, and any acute or chronic medical condition that increase the risk of interventions (e.g., heart disease)
  • Any underlying disease likely to limit life span and/or increase risk of interventions including cardiovascular disease (e.g. unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class>2), pulmonary disease with dependence on oxygen or daily use of bronchodilators, cancer requiring treatment in the past 5 years unless the prognosis is considered good, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly), hepatitis or other chronic gastrointestinal disease (pancreatitis, inflammatory bowel disease), renal disease, significant anemia, recent surgery or significant abdominal surgery, major psychiatric or any eating disorder, acute coronary syndrome or stroke in the past 6 months
Zentrale Studienkontakte
Kontakt: Olivia Hughes, 7737022348, [email protected]
1 Studienstandorte in 1 Ländern

Illinois

University of Chicago, Chicago, Illinois, 60637, United States
UChicago IRB, Kontakt, 773-702-6505
Esra Tasali, MD, Hauptprüfer
Offene Rekrutierung