Young Adult Weight Loss Study

A Novel Intervention for Weight Loss in Young Adults

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: Lifestyle; Behavioral: Lifestyle II

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, with an optional 12-month follow-up. 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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Becky Tucker; Phone Number: 7737022348; Email: tuckerb@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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
• Habitual daytime naps
• Regular travel across time zones
• Extreme chronotypes
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lifestyle Intervention; Diet and exercise coaching	Behavioral: Lifestyle; All participants will receive diet and exercise goals and coaching.
Experimental: Lifestyle Intervention II; Diet and exercise coaching	Behavioral: Lifestyle II; All participants will receive diet and exercise goals and coaching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Change in weight (kg) will be determined from Visit 2 (baseline) and Visit 4 (6 months) weights.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University
• Investigators: Principal Investigator: Esra Tasali, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: IRB23-1677; 1R01DK136214-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No