Small Changes Program for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach called the Small Changes program, designed to help people lose weight and improve health. Researchers aim to compare the program's effectiveness with standard weight loss therapy by examining body weight, blood health markers, and blood pressure. Suitable participants have a Body Mass Index (BMI) of 25 or more, have not experienced significant weight changes recently, and can adhere to a diet plan. Participants must also attend regular in-person and phone appointments over the 12-week study period. As an unphased trial, this study provides a unique opportunity to contribute to innovative weight loss research and potentially enhance health.
Will I have to stop taking my current medications?
The trial requires that you stop taking any anti-obesity or diabetes medications that induce weight loss, such as GLP-1RAs, to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Small Changes program, which promotes minor adjustments in diet and exercise, is generally safe for individuals aiming to lose weight. Studies have found that this method effectively boosts physical activity and reduces calorie intake without major side effects.
Participants in these studies did not report any serious negative effects, indicating that the program is manageable. By suggesting small, manageable steps instead of drastic changes, the program reduces the risks often associated with more extreme weight loss methods. This makes it a safe option for those considering participation in a clinical trial focused on weight management.12345Why are researchers excited about this trial?
Researchers are excited about the Small Changes program for obesity because it takes a fresh approach by emphasizing gradual, manageable adjustments to everyday habits rather than drastic lifestyle overhauls. Unlike standard weight loss treatments that often rely on intensive behavioral therapy, this program encourages small, sustainable changes that are easier for individuals to stick with long-term. This strategy could offer a more accessible and less daunting path to weight loss, potentially leading to better adherence and more lasting results.
What evidence suggests that the Small Changes program could be effective for obesity?
Research has shown that the Small Changes program, which participants in this trial may receive, can aid in short-term weight loss. A review of several studies found that programs like this one, lasting six months or less, helped people lose weight. Another study found that about half of the participants in similar programs lost a significant amount of weight over a year. However, some research suggests that these small changes might not always prevent long-term weight gain. Overall, while the program can initially help with weight loss, its long-term success may vary for each person.12678
Who Is on the Research Team?
Leah Whigham, PhD
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Small Changes program or standard behavioral therapy for weight loss
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Small Changes program
Trial Overview
The 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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Published Research Related to This Trial
Citations
A small change approach to prevent long-term weight gain ...
We found that the SCA was not more effective than MA in preventing weight gain at 2 or 3 years in adults with overweight or obesity. We had ...
Weight Loss in Short-Term Interventions for Physical ...
This meta-analysis of 14 RCTs found that interventions lasting 6 months or less were effective at achieving weight loss. Each study showed ...
Weight Loss Patterns and Outcomes Over 12 Months on a ...
This commercial weight loss program was shown to be effective, with 1 in 2 members achieving clinically significant results after 1 year.
Effect of an Online Weight Management Program ...
Even though the overall weight loss was modest, the mean weight loss among patients in the combined intervention group at 12 months was 3.0%, ...
Small Changes and Lasting Effects (SCALE) Trial
This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and ...
Can a small-changes approach help address the obesity ...
The small-changes approach has been shown to be effective at increasing total physical activity, decreasing total energy intake, and preventing or reducing ...
Behavior‐change lifestyle interventions for the treatment of ...
This scoping review discusses optimal behavior-change lifestyle interventions in the treatment of overweight and obesity in children and adolescents.
Weight Loss Treatment and Longitudinal Weight Change ...
These findings suggest WMT can support 5% or greater weight loss for individual patients, but low utilization limits their population-level potential.
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