A Novel Intervention for Weight Loss in Young Adults
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Weight Loss
- Sponsor
- University of Chicago
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Weight loss
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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?
Detailed 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 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.
Investigators
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Weight loss
Time Frame: 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.