Obesity
Conditions
Keywords
Small Changes, weight loss
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
Interventions
BEHAVIORALSmall 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 grocery spending and habits somewhat
BEHAVIORALStandard behavioral therapy for weight loss
Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight | Baseline,12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in Hemoglobin A1C levels | Baseline, 12 weeks |
| Change in fat mass | 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 | 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 |
Countries
United States
Contacts
Primary ContactLeah Whigham, PhD
Backup ContactJuan Aguilera
Outcome results
None listed