Not yet recruiting NCT06668272
Small Changes Clinical Weight Loss Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Small Changes program, Standard behavioral therapy for weight loss.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Behavioral Small Changes program
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 groce - Behavioral Standard behavioral therapy for weight loss
Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.
Primary outcome measures
- Change in weight [Time frame: Baseline,12 weeks]
Secondary outcome measures (9)
- Change in Hemoglobin A1C levels [Time frame: Baseline, 12 weeks]
- Change in triglycerides levels [Time frame: Baseline, 12 weeks]
- Change in total cholesterol levels [Time frame: Baseline, 12 weeks]
- Change in HDL cholesterol levels [Time frame: Baseline, 12 weeks]
- Change in fasting blood glucose levels [Time frame: Baseline, 12 weeks]
- Change in lean body mass [Time frame: baseline, week 4, week 8, week 12]
- Change in fat mass [Time frame: baseline, week 4, week 8, week 12]
- Compliance as measured by the percentage of meals that follow the diet plan as reported in a daily food log [Time frame: From baseline to week 12]
- Attrition as assessed by number of participants that complete the study [Time frame: week 12]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- The University of Texas Health Science Center at Houston — Houston
- Texas Tech University — Lubbock
Identifiers
NCT: NCT06668272 · HSC-SPH-24-0430