Trial Summary
What is the purpose of this trial?
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
Eligibility Criteria
This trial is for adults with a BMI of 25 or higher who've maintained a stable weight recently, are willing to follow a diet plan, live in the study area, can attend appointments every two weeks, and have their doctor's okay to lose weight. It's not for pregnant women, those with recent commercial dieting history, eating disorders, severe dietary restrictions due to allergies, serious health conditions like kidney or liver disease or cancer; nor people who've had bariatric surgery or take certain diabetes medications.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
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Exclusion Criteria
Pregnant or lactating
History of commercial weight loss program participation within the last six months
History of anorexia nervosa or other eating disorders
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Treatment Details
Interventions
- Small Changes program (Behavioral Intervention)
Trial OverviewThe trial is testing if the Small Changes program helps people lose weight better than standard behavioral therapy. Participants will be monitored over 12 weeks to see changes in body composition, metabolic health markers in blood tests and blood pressure levels. The study also looks at how many stick with it and follow the rules.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Small Changes programExperimental Treatment1 Intervention
Group II: Standard behavioral therapy for weight lossActive Control1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of Texas Health Science Center at HoustonHouston, TX
Texas Tech UniversityLubbock, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center, HoustonLead Sponsor