A Novel Intervention for Weight Loss in Young Adults

The University of Chicago logo

The University of Chicago

Status

Not yet enrolling

Conditions

Weight Loss

Treatments

Behavioral: Lifestyle
Behavioral: Lifestyle II

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06230744
IRB23-1677
1R01DK136214-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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? * How does the combination of behavioral intervention and technology influence energy intake in young adults?

Full description

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. 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.

Enrollment

320 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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 (apnea-hypopnea index, AHI>5) or history of any other sleep disorder. AHI is a standard metric used in clinical practice to determine the presence and severity of sleep apnea based on the number of times the respiratory upper airway obstructions occur per hour of sleep. An AHI>5 indicates the presence of sleep apnea.
  • Irregular menses, menopausal symptoms or post-menopausal, currently pregnant, trying to get pregnant or nursing
  • Night or rotating shift work
  • 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, illegal drug use
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

320 participants in 2 patient groups

Lifestyle Intervention
Other group
Description:
Diet and exercise coaching
Treatment:
Behavioral: Lifestyle
Lifestyle Intervention II
Experimental group
Description:
Diet and exercise coaching
Treatment:
Behavioral: Lifestyle II

Trial contacts and locations

0

Loading...

Central trial contact

Becky Tucker

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems