Vekttapstudie for unge voksne
En ny intervensjon for vekttap hos unge voksne
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?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Olivia Hughes
- Telefonnummer: 7737022348
- E-post: bhughes8@bsd.uchicago.edu
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60637
- Rekruttering
- University of Chicago
-
Hovedetterforsker:
- Esra Tasali, MD
-
Ta kontakt med:
- UChicago IRB
- Telefonnummer: 773-702-6505
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Lifestyle Intervention
Diet and exercise coaching |
All participants will receive diet and exercise goals and coaching. |
|
Eksperimentell: Lifestyle Intervention II
Diet and exercise coaching |
All participants will receive diet and exercise goals and coaching. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight loss
Tidsramme: Baseline and 6 months
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Esra Tasali, MD, University of Chicago
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB23-1677
- 1R01DK136214-01A1 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .