Small Changes Clinical Weight Loss Trial
Not Applicable
Not yet recruiting
- Conditions
- Obesity
- Registration Number
- NCT06668272
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in weight Baseline,12 weeks
- Secondary Outcome Measures
Name Time Method Compliance as measured by the percentage of meals that follow the diet plan as reported in a daily food log From baseline to week 12 Attrition as assessed by number of participants that complete the study week 12 Change in lean body mass baseline, week 4, week 8, week 12 Change in fat mass baseline, week 4, week 8, week 12 Change in Hemoglobin A1C levels Baseline, 12 weeks Change in triglycerides levels Baseline, 12 weeks Change in total cholesterol levels Baseline, 12 weeks Change in HDL cholesterol levels Baseline, 12 weeks Change in fasting blood glucose levels Baseline, 12 weeks
Trial Locations
- Locations (2)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Texas Tech University
🇺🇸Lubbock, Texas, United States