Small Changes Clinical Weight Loss Trial

This study is testing two different approaches to weight loss: the "Small Changes program" and "Standard behavioral therapy for weight loss." Researchers want to see how effective the Small Changes program is at helping people lose weight. They will also look at changes in body composition, blood markers (signs in your blood that show how healthy you are), and blood pressure. You might be able to join if you are between 18 and 70 years old, have a Body Mass Index (BMI) of 25 or higher, and your weight has been stable for the past three months. The main goal is to measure how much weight participants lose over 12 weeks. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 52 participants. It compares two behavioral weight loss programs.
What's involved
You would need to follow a written diet plan daily and attend bi-weekly in-person and phone appointments for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your weight will be measured at the beginning and again at 12 weeks.

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NCT06668272

Small Changes Clinical Weight Loss Trial

Not Yet Recruiting
NAAges 18–70InterventionalTreatment
The University of Texas Health Science Center, Houston
~52 participants
Updated 2024-10-31 on ClinicalTrials.gov
What's tested:Small Changes programStandard behavioral therapy for weight loss

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in weight
Measured over Baseline,12 weeks
Obesity
2 sites across 1 states
Texas2
  • Leah Whigham, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

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

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.
  • Change in weightBaseline,12 weeks