Clinical trial

Small Changes Clinical Weight Loss Trial

Opening soon · Not applicable · 1 countries · Registry ID NCT06668272

Opening soonNot applicableInterventional

What this study is 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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.

Treatments and study arms

Small Changes program

Behavioral

Participants will be asked to track their compliance with their Small Changes diet plan using a simple checklist record . Participants will be asked to follow their diet plan every day. They are encouraged to create a diet plan that is as close to their current diet as possible. Meal options include make-from-scratch recipes, quick "grab-and-go" options,and restaurant options. There may be some time involved in learning the recipes and the routine of their new diet. It also may alter their grocery spending and habits somewhat