Small Changes Clinical Weight Loss Trial

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Obesity

Treatments

Behavioral: Standard behavioral therapy for weight loss

Behavioral: Small Changes program

Study type

Interventional

Funder types

Other

Identifiers

NCT06668272

HSC-SPH-24-0430

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance

Enrollment

52 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body Mass Index greater than or equal to 25
Stable weight with less than a 5% body weight change in the past 3 months.
Willingness and ability to follow a written dietary plan.
Ambulatory and capable of attending bi-weekly in-person and phone appointments.
Must reside in the geographic area for the duration of the 12-week study.
Clearance for weight loss by their health care provider.

Exclusion criteria

Pregnant or lactating.
Acute medical conditions such as kidney disease, liver disease, pancreatitis, or cancer.
A history of bariatric surgery or gastrointestinal resection.
Current use of anti-obesity medications or diabetes medications, such as Glucagon-like peptide-1 receptor agonists (GLP-1RAs), that induce weight loss.
A history of commercial weight loss program participation within the last six months.
A history of anorexia nervosa or other eating disorders.
A history of anxiety or depression.
Extreme dietary restrictions or allergies that limit the ability to follow the weight loss plan.