An interventional study of Small Changes program and Standard behavioral therapy for weight loss in Obesity, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's planned enrollment of 52 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Small Changes program
Behavioral: Standard behavioral therapy for weight loss
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
Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.
Change in weight
Time frame: Baseline,12 weeks
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
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston